[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infant-development\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infant-development":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,47,76,108,141,170,195,217,245,268,302,327,365,390,418,442,464,491,522,550,574,604,630,652,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100584679","breastmilk-in-response-to-a-bout-of-exercise-100584679",false,"NCT06892483","Breastmilk in Response to a Bout of Exercise","Breastmilk Composition in Response to a Bout of Exercise","Exclusion Criteria:\n\n* Active coronary artery disease or heart failure.\n* Participation in a structured exercise program ≥ 1 day\u002Fweek in the \"inactive\" subcohort or \\\u003C 3 days per week in the \"active\" subcohort.\n* A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:\n\n  * Abnormal liver function test results (Transaminase \\>2 times the upper limit of normal\n  * Abnormal renal function test results (calculated GFR \\\u003C60 mL\u002Fmin\u002F1.73m2);\n  * If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study\n  * Uncontrolled thyroid disease (TSH undetectable or \\>10 mlU\u002FL); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise\n  * Abuse of alcohol or recreational drugs\n  * Active tobacco smoking within the past 3 months\n  * Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis).\n  * Uncontrolled arterial hypertension (Resting diastolic blood pressure \\>90 mmHg and\u002For systolic blood pressure \\>160 mmHg) at the time of screening.\n  * A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol\n  * Active pregnancy\n  * Restrictions on Use of Other Drugs or Treatments:\n\n    * Any other medication believed to be a contraindication to the subject's participation.",true,"FEMALE","18 Years","45 Years",{"count":22,"type":23},60,"ESTIMATED","1 Month","OBSERVATIONAL","The purpose of this study is to unveil the mechanistic benefits of a bout of postpartum maternal exercise on infant health that are provided by breastmilk.",[28,29,30],"Infant Development","Obesity, Childhood","Diabetes, Childhood-Onset",[32,33],"Breast milk","Postpartum exercise","RECRUITING","2026-06-19",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2025-04-21",{"date":42,"type":23},"2028-09-25",{"name":44,"class":45},"Mayo Clinic","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100524377","developmental-impacts-of-microplastics-exposure-in-early-life-100524377","NCT06107933","Developmental Impacts of Microplastics Exposure in Early Life","Developmental Impacts of MicroPLastics Exposure in Early Life","DIMPLE","Inclusion Criteria:\n\n* All gender expressions\n* Mothers at 1 or 3 months postpartum (± 2 weeks)\n* Intent to exclusively breastfeed for ≥ 6 months\n* Nulliparous and singleton births\n* Receiving only breast milk from the mother, with no formula supplementation\n\nExclusion Criteria:\n\n* Physical, mental, or cognitive disability that prevents participation; current incarceration\n* Chronic conditions in mother and\u002For infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome\u002Fdisease), conditions diagnosed for the first time during pregnancy (e.g. gestational diabetes), neurological conditions in mother and\u002For infant (e.g. epilepsy, seizures), psychological conditions in mother and\u002For infant (e.g. bipolar disorder), or neurological\u002Fpsychological conditions diagnosed in mother during or immediately after pregnancy (e.g. postpartum depression)\n* Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery\n* Maternal antibiotic use during pregnancy or the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.\n* Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.\n* PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression\n* Infants who are intersex\n* Smoking, drug use (including marijuana use), or alcohol abuse",{"count":56,"type":23},40,"The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are:\n\n* What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample?\n* Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool?\n* Which environmental and lifestyle factors are most predictive of maternal MNP burden?\n* Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories?\n\nParticipants will:\n\n* Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc.\n* Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool\n* Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness",[28,59,60],"Breast Feeding","Environmental Exposure",[62,63,64,65,66],"microplastic","breastmilk","infant microplastic exposure","gut microbiome","fecal metabolome","2026-06-05",{"date":69,"type":38},"2026-06-09",{"date":71,"type":38},"2023-10-01",{"date":73,"type":23},"2027-01-01",{"name":75,"class":45},"Johns Hopkins Bloomberg School of Public Health",{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":17,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100509669","screening-for-autism-in-9-month-olds-by-measuring-social-visual-engagement-100509669","NCT05916430","Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement","Community-viable Screening for Autism Spectrum Disorder (ASD) in 9-month-old Infants Using Quantitative Eye-tracking Assays of Social Visual Engagement","Inclusion Criteria:\n\n* Infants between the chronological ages of 8-10 months\n* Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision)\n* Participants' parents\u002Fcaregivers must be able to understand and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n\\- Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).","ALL","8 Months","10 Months",{"count":87,"type":23},2120,"The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.",[90,28],"Autism",[92,93,94,95,96,97],"Screening","well-baby visits","Social Development","Communicative Development","Development Disabilities","Autism Spectrum Disorders","2026-06-02",{"date":100,"type":38},"2026-06-04",{"date":102,"type":38},"2023-02-02",{"date":104,"type":23},"2027-12",{"name":106,"class":45},"Emory University",2,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":83,"minAge":19,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":46},"100543158","the-playful-learning-in-infancy-program-100543158","NCT06352229","The Playful Learning in Infancy Program","The Playful Learning in Infancy Program (PLIP): A Pilot Feasibility Study of an Universal Educational Parenting Program Using a Parallel Group Design","PLIP","Inclusion Criteria:\n\n* Residence address in the Danish municipalities of Hvidovre or Billund\n* Residence address with child or legal custody of the child\n* Child is between 1-7 months old\n* Understands Danish or English\n\nExclusion Criteria:\n\n* Parental age under the age of 18 when the child is born\n* Multiple pregnancy",{"count":117,"type":23},2327,"INTERVENTIONAL",[120],"NA","In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.\n\nThe aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.\n\nEvaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program.",[123,28],"Parent-Child Relations",[125,126,127,128,129,130,131],"Universal intervention","Playful Learning","Infant","Parental competence","Socioemotional","Public health visitors","Prevention","2026-05-20",{"date":134,"type":38},"2026-05-26",{"date":136,"type":38},"2023-06-01",{"date":138,"type":23},"2026-11-30",{"name":140,"class":45},"University of Copenhagen",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":118,"phases":150,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":46},"100577343","breastfeeding-education-support-tool-100577343","NCT06797063","Breastfeeding Education Support Tool","BEST4Baby","Inclusion Criteria:\n\n* at least 18 years of age,\n* pregnant and 20-27 weeks of gestation at study enrollment,\n* singleton pregnancy,\n* no major antepartum complications,\n* living in a research site,\n* planning to deliver in the cluster area,\n* capable of giving informed consent,\n* willing to be visited by a PC and research personnel for up to 12 months post-delivery.\n\nExclusion Criteria:\n\ncomorbidities impacting breastfeeding,\n\n\\- severe psychological illness that could interfere with consent and study participation. Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences: illness or clinical complications warranting prolonged hospitalization, stillbirth, low birth weight (\\\u003C 2500 g), congenital abnormality, or neonatal death.",{"count":149,"type":23},336,[120],"The proposed project seeks to evaluate the effectiveness and implementation of the Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention, an mHealth-supported community-based peer counselor breastfeeding intervention for mothers in India. Given that rates of optimal infant feeding practices have remained stagnant over the past two decades in India, and that India is the most populous country and icontributes one-fifth of all global live births, this project could have major global health implications if the intervention is found to improve maternal breastfeeding practices and infant clinical outcomes. The project will also provide evidence needed to adopt BEST4Baby nationally and in other low resource communities.",[153,28,154,59],"Breastfeeding, Exclusive","Infant Growth",[156,157,158,159],"breastfeeding","India","infant feeding","peer counselors","NOT_YET_RECRUITING","2026-05-04",{"date":163,"type":38},"2026-05-05",{"date":165,"type":23},"2026-09-01",{"date":167,"type":23},"2029-09-01",{"name":169,"class":45},"Thomas Jefferson University",{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":17,"sex":83,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":46},"100633824","cortical-tracking-of-speech-in-the-first-year-of-life-100633824","NCT07531706","Cortical Tracking of Speech in the First Year of Life","Cortical Tracking of Speech in the First Year of Life: a Window Into (a)Typical Language Acquisition","Inclusion Criteria:\n\n* Healthy infants aged between 7 and 8 months\n* Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and\u002For learning disorders).\n* Both parents are native-Italian speakers\n\nExclusion Criteria:\n\n* Gestational age \\\u003C 37 weeks and\u002For birth-weight \\\u003C 2500 grams\n* APGAR scores at birth at 1' and 5' \\\u003C 7\n* Bayley Cognitive Score \\\u003C 7\n* Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.","30 Weeks","34 Weeks",{"count":180,"type":23},50,"The goal of this observational study is to investigate early neural mechanisms underlying the processing of spoken language, specifically the phenomenon of cortical tracking, and to determine whether these mechanisms can serve as early predictors of later language development outcomes in infants, including both typical and atypical trajectories.\n\nThe main questions it aims to answer are:\n\n* How do infants with and without a familial history of language and learning impairments differ in their neural ability to track speech and non-speech auditory stimuli at an early stage of development (around 8 months of age)?\n* To what extent do early cortical tracking mechanisms predict later language abilities, including both receptive and expressive skills, measured at approximately 18 months of age? Researchers will compare infants with a familial risk for language and learning impairments (FH+) to infants without such risk (FH-) to determine whether differences in early neural processing of auditory stimuli are associated with later language outcomes.\n\nParticipants will:\n\n* undergo a neurophysiological assessment involving non-invasive electroencephalographic (EEG) recording while being exposed to auditory stimuli, including: speech stimuli (pre-recorded simple stories in Italian, presented in infant-directed speech); non-speech stimuli (musical sounds matched for rhythmic and acoustic properties)\n* take part in a developmental assessment at approximately 8 months of age, including standardized measures of cognitive and early linguistic abilities\n* be involved in a follow-up assessment approximately 10 months later (around 18 months of age), during which standardized tests will evaluate language comprehension and production abilities\n* have additional background information collected, including family history of language and learning disorders and socio-demographic characteristics, to better understand potential risk and protective factors The study follows a longitudinal design and uses non-invasive procedures that do not require active responses from the infant.",[183,184,28,185],"Language Development","Language Development Disorders","Infant Developmental Assessment","2026-04-09",{"date":188,"type":38},"2026-04-15",{"date":190,"type":38},"2025-10-14",{"date":192,"type":23},"2028-02",{"name":194,"class":45},"IRCCS Eugenio Medea",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":46},"100470268","mediterranean-diet-on-pregnancy-and-foetus-development-100470268","NCT05403632","Mediterranean Diet on Pregnancy and Foetus Development","Influence of Mediterranean Dietary Habits on Pregnancy and Foetus Development: the Role of Epigenetics and Inflammation","Inclusion Criteria:\n\n* pregnant women attending the Units of Obstetrics and Gynecology at Neuromed Clinical Research Network\n* women within the first trimester of pregnancy\n* women who express the willing to deliver at the aforementioned operating units\n\nExclusion Criteria:\n\n* pregnancy with foetuses with known chromosomal or congenital malformation\n* history of inflammatory disease\n* use of immunosuppressant drugs\n* pre-existing diabetes or hypertension\n* conception by heterologous artificial insemination\n* malabsorptive bariatric surgery\n* eating disorders","50 Years",{"count":204,"type":23},2000,"The Mediterranean-style diet has been associated with longevity, long-life wellbeing, lower risk of cardiovascular disease, cancer, obesity, and metabolic syndrome. Research is pointing to the benefits that MeD could have in pregnant. Pregnancy is a very complex period and recently, the attention has been focused on the possibility that healthy dietary patterns positively influence pregnancy and the development of organs in the offspring. The mechanisms through which MeD influences pregnancy and fetal growth may partly depend on its antinflammatory properties and possibly on changes in epigenetic mechanisms. Systemic inflammation might contribute to the association between maternal obesity and less favorable neurodevelopmental outcomes. The investigators aim to define how maternal adhesion to MeD may affect pregnancy and new-born development, hence representing a notable burden from a public health and social perspective. Main objective of this project is to build up a birth cohort suitable to investigate the role of maternal dietary habits on maternal and new-born health, with special focus on MeD and its possible mechanism of action through epigenetic and inflammation changes. To establish a mother\u002Fnew-born cohort, collect detailed information on maternal dietary habits and set-up a biobank of biological samples to evaluate the association between dietary habits and pregnancy outcomes. The investigators will recruit 2000 pairs (mother, new-born) in different obstetrics departments. To investigate the association between maternal dietary habits, foetal growth and offspring development and possible mediation by the inflammation profile of the mother. To understand whether maternal dietary habits are associated with epigenetic changes in the offspring and if this process is driven by the inflammation profile of the mother. Venous blood samples will be obtained at the baseline and at each gestational period for ultrasound at 11-13 gestational weeks, 20-22 weeks and 30-32 weeks. Women will be followed-up with standard clinical and 2D ultrasound examinations at gestational weeks 11-13, 20-22 and 30-32 to evaluate the fetal growth. Offspring development will be assessed at 6, 12, 18, 24 months of age. After delivery, the investigators will collect umbilical cord blood and saliva samples from new-born using standard procedures. To understand if new-born epigenetics is associated with infant physical and neurocognitive development in the following 2 years.",[207,208,28],"Pregnancy Outcomes","Fetal Development","2026-04-08",{"date":186,"type":38},{"date":212,"type":38},"2023-05-01",{"date":214,"type":23},"2027-12-31",{"name":216,"class":45},"Neuromed IRCCS",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":83,"minAge":224,"maxAge":177,"enrollmentInfo":225,"targetDuration":4,"studyType":118,"phases":227,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":107},"100557298","the-impact-of-music-medicine-on-preterm-brain-development-and-behavior-100557298","NCT06536296","The Impact of Music Medicine on Preterm Brain Development and Behavior","The Impact of Music Medicine on Preterm Brain Development and Behavior - A Two-Center Randomized Controlled Trial \"The Lullaby Study\"","Inclusion Criteria:\n\n* Very preterm infants born between 24+0 and 30+6 weeks' gestational age (GA) from 2 level III NICUs (Brigham and Women's Hospital, Boston, MA and Yale New Haven, CT)\n* Infants who are medically stable per the clinical care team\n\nExclusion Criteria:\n\n* Infants with major genetic or congenital anomalies known to be associated with developmental delay\n* Infants with severe brain injury (such as intraparenchymal hemorrhage, severe white matter injury)\n* Infants who are severely ill infants for whom MBI is not feasible\n* Infants of parents who cannot complete questionnaires in English or Spanish.","24 Weeks",{"count":226,"type":23},243,[120],"The investigators are conducting a two-site randomized control trial with the aim of defining the impact of music (M) without or with parent voice (MPV) on very preterm infants' acute and cumulative stress, intranetwork connectivity on term brain MRI, and language and other neurodevelopmental outcomes at two years corrected age. This is based on the hypothesis that infants in MPV arm are expected to experience the greatest benefit compared with infants receiving standard care.",[28,183,230,231],"Prematurity","Stress",[233,234,235],"Preterm","Neurodevelopment","Music-based Intervention","2026-03-23",{"date":238,"type":38},"2026-03-25",{"date":240,"type":38},"2025-05-19",{"date":242,"type":23},"2031-03-01",{"name":244,"class":45},"Brigham and Women's Hospital",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":17,"sex":83,"minAge":24,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":46},"100261507","measurement-of-energy-metabolism-in-infants-100261507","NCT02683473","Measurement of Energy Metabolism in Infants","Measurement of Energy Metabolism in Infants: BabyEE Pilot","BabyEE Pilot","Inclusion Criteria:\n\n* Healthy, full-term infant\n* Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit\n* Exclusively fed breast milk and\u002For infant formula\n* Willing to accept doubly-labeled water\n\nExclusion Criteria:\n\n* Unable to complete 3 clinic visits within about 14 days at Pennington Biomedical Research Center\n* Born preterm (\\\u003C 37 weeks gestation)\n* Congenital abnormality or disability\n* Gastric reflux\n* Acute illness within 7 days of the study (fever, diarrhea)\n* Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence or reflux such as Pepcid)","3 Months",{"count":255,"type":23},70,"The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.",[28,258],"Infant Overnutrition","2026-03-16",{"date":261,"type":38},"2026-03-18",{"date":263,"type":38},"2016-03-16",{"date":265,"type":23},"2027-06-30",{"name":267,"class":45},"Pennington Biomedical Research Center",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":17,"sex":83,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":279,"conditions":280,"keywords":283,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":46},"100625122","understanding-early-development-of-infants-and-toddlers-100625122","NCT07418528","Understanding Early Development of Infants and Toddlers","Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning","Inclusion Criteria:\n\n* Infants and young children aged from 16 days to 42 months at the time of assessment.\n* Participation of a parent or legal guardian able to provide informed consent.\n* Child's ability to participate in a standardized developmental assessment appropriate for age and developmental level.\n* Availability of basic medical and perinatal information provided by parents or caregivers.\n* Assignment to one of the predefined study cohorts based on medical history and developmental status:\n\nchildren from the general population (control group), children with developmental delay, children with confirmed genetic conditions, children born preterm between 33 and 37 weeks of gestation, children born before 33 weeks of gestation, children with a diagnosis of cerebral palsy.\n\nExclusion Criteria:\n\n* Severe acute medical condition at the time of assessment preventing participation in the psychological evaluation.\n* Uncorrected severe sensory impairments (e.g., profound visual or hearing impairment) that preclude valid administration or interpretation of the developmental assessment.\n* Medical instability or conditions requiring immediate intensive medical care.\n* Lack of informed consent from a parent or legal guardian.\n* Inability of the parent or caregiver to provide reliable information required for questionnaire-based assessment.","16 Days","42 Months",{"count":278,"type":23},1200,"The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life.\n\nThe study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian.\n\nIn addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills.\n\nThe main research questions addressed by this study are:\n\nWhat is the developmental profile of infants and young children in the first years of life?\n\nWhat relationships exist between different domains of early development within a biopsychosocial model of child functioning?\n\nCan specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood?\n\nHow does age differentiate the structure and variability of developmental functioning across assessed domains?\n\nThe study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.",[281,28,282],"Early Childhood Development","Child Development",[284,285,286,234,287,288,289,290,291],"Early development","Infant development","Toddler development","Cognitive development","Language development","Motor development","Social-emotional development","Adaptive behavior","2026-02-19",{"date":294,"type":38},"2026-02-23",{"date":296,"type":38},"2025-01-02",{"date":298,"type":23},"2027-03",{"name":300,"class":301},"Bartosz M. Radtke","OTHER_GOV",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":83,"minAge":4,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":118,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":46},"100514185","continuous-delivery-room-skin-to-skin-study-for-moderate-and-late-preterm-infants-100514185","NCT05975203","Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants","COSY","Inclusion Criteria:\n\n* preterm birth between gestational age of 32 0\u002F7 and 36 6\u002F7 weeks\n* vaginal delivery\n* singleton\n* informed consent before birth\n\nExclusion Criteria:\n\n* malformations or syndromes of the infant\n* resuscitation of the infant\n* maternal psychological or severe physical illness\n* lack of German language skills",{"count":22,"type":23},[120],"The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:\n\n* does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?\n* does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?\n\nParticipants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.",[313,314,28],"Preterm Birth","Mother-Infant Interaction",[316,317],"preterm behavioral epigenetics","skin-to-skin contact","2026-02-18",{"date":320,"type":38},"2026-02-20",{"date":322,"type":38},"2023-08-04",{"date":324,"type":23},"2028-12-31",{"name":326,"class":45},"University of Cologne",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":17,"sex":83,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":363,"locationsCount":46},"100546559","neuroimaging-of-babies-during-natural-sleep-to-assess-typical-development-and-cerebral-palsy-100546559","NCT06396520","Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy","NIBS-CP","Inclusion Criteria High-Risk population:\n\nGroup: 'Newborn-detectable risk-pathway'\n\n* Preterm birth with gestational age below 32 weeks\n* Birth weight below 1500 g\n* Moderate to severe brain injury (A label of moderate to severe brain injury was considered if there was Papile grade three to four intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition)\n* History (e.g., neonatal seizures, ECMO, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (malformations in CNS, increased tone)\n\nGroup: 'Infant detectable risk-pathway'\n\n* Inability to sit independently by age 9 months\n* Hand function asymmetry or crawl asymmetry\n* Inability to take weight through the plantar surface of the feet\n* History (e.g., as above) or neurological risk factors\n\nAdditional inclusion criteria for inclusion in NIBS-CP for both CP-risk groups:\n\n\\- Consent to health-relevant information on clinical findings being passed on to the medical doctors in CP-EDIT and\u002For their primary care physician.\n\nInclusion Criteria Typically developing infant population:\n\n* Born \\>37 weeks\n* Uneventful birth\n* No known history of brain injury\n* No neurological condition\n* Consent to health-relevant information on clinical findings being passed on to their primary care physician or relevant medical doctors, e.g., neuropaediatrician.\n\nExclusion Criteria (all groups):\n\n* Infants have any MRI contraindications, e.g., pacemaker or other implanted electronic devices.\n* Families do not speak or understand Danish.\n* Families do not wish to be informed about incidental findings on the MRI, or scores within the clinical range in the neurological, motor, or cognitive assessments.","2 Months","11 Months",{"count":337,"type":23},200,"Background: Early diagnosis of cerebral palsy (CP) is crucial, enabling intervention when neuroplasticity is at its highest. Magnetic resonance imaging (MRI) plays a vital role in CP diagnosis. Currently, diagnostic MRI of newborns and infants with suspected brain damage relies heavily on structural MR images. The current study aims to i) establish procedures for clinical infant and toddler MRI during natural sleep, ii) use advanced MRI sequences, such as advanced diffusion-weighted imaging (DWI), that may be more sensitive in detecting early brain damage, and iii) map relationships between early brain development, and motor function and development.\n\nMethods: The NIBS-CP study will enroll approximately 200 infants either at risk for CP or typically developing. Infants will be followed longitudinally (for three waves) between 3 months and 2 years of age with cerebral MRI at 3 Tesla and comprehensive assessments of motor and cognitive functioning. The MRI protocol includes advanced diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy. The motor and cognitive assessments include Hand Assessment in Infants, Alberta Infant Motor Scales, Hammersmith Infant Neurological Examination, Peabody Developmental Motor Scales, Bayley Scales of Infant Development, and Ages and Stages Questionnaires. NIBS-CP aims to establish normative material on early brain development of Danish children and conduct normative modeling of typical and atypical development to identify deviations in brain development at the level of the single child.\n\nDiscussion: Identifying predictive brain structural features of motor function and motor development is key to the future use of early MRI in the clinical work-up, as this promotes early diagnosis and (clinical) intervention strategies tailored to the individual child.",[340,28,341],"Cerebral Palsy","Development, Infant",[343,344,345,289,287,346,347,348,349,340,350,351,352,353,354,355,356],"MRI","Brain development","Diffusion MRI","Normative modelling","Hand assessment for infants","Alberta Infant Motor scale","Motor functioning","Typically developing","Infants","Toddlers","Children","Peabody Developmental Motor Scales","Corticospinal tract","Motor system","2026-01-27",{"date":359,"type":38},"2026-01-28",{"date":361,"type":38},"2024-06-01",{"date":214,"type":23},{"name":364,"class":45},"Danish Research Centre for Magnetic Resonance",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":83,"minAge":373,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":118,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":46},"100541873","infant-maternal-partnership-and-cognitive-training-study-for-preterm-infants-100541873","NCT06335524","Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants","Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants: A Randomized Clinical Trial","IMPACT","Inclusion Criteria:\n\n* inborn at UAB, delivered at less than 34 weeks' gestation, 32-39 weeks' PMA, off sedatives, and off invasive respiratory support.\n\nExclusion Criteria:\n\n* a major malformation, a known syndrome, enrolled in a competing trial targeting neurodevelopmental outcomes as a primary outcome.","1 Week","17 Weeks",{"count":376,"type":23},188,[120],"This study will test the hypothesis that in preterm infants a caregiver-implemented early developmental intervention (EDI) using finger puppets to develop joint attention and encourage interactive communication with routine EDI care including Bookworm training compared with routine EDI care including Bookworm training alone will increase the Ages and Stages Questionnaire® score at 12 months corrected age.",[282,28,380],"Infant, Premature, Diseases","2025-12-19",{"date":383,"type":38},"2025-12-29",{"date":385,"type":38},"2024-11-01",{"date":387,"type":23},"2028-12",{"name":389,"class":45},"University of Alabama at Birmingham",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":17,"sex":83,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":118,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":417},"100505978","effect-of-partially-hydrolyzed-whey-based-infant-formulas-on-growth-and-tolerability-in-healthy-term-infants-100505978","NCT05868408","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\]), if applicable)\n2. Infant gestational age ≥37 completed weeks\n3. Infant birth weight of ≥2.5 kg and ≤4.5 kg\n4. Singleton birth\n5. Infant postnatal age ≤28 days (date of birth = day 0)\n6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk\n7. Infant's parent(s)\u002FLAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth\n2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)\n3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)\n4. Infants with special dietary needs other than standard infant formula\n5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance\u002Fallergy, or lactose intolerance or severe food allergies that impact diet\n6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n7. Currently participating or having participated in another interventional clinical trial prior to enrollment","0 Days","28 Days",{"count":400,"type":23},234,[120],"This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.",[404,405,406,28,407],"Infant Nutritional Physiological Phenomena","Infant Formula","Infant Health","Growth and Development","2025-12-18",{"date":381,"type":38},{"date":411,"type":38},"2023-08-17",{"date":413,"type":23},"2028-06",{"name":415,"class":416},"Société des Produits Nestlé (SPN)","INDUSTRY",3,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":17,"sex":83,"minAge":426,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":46},"100615351","behavioral-assessment-method-index-100615351","NCT07291479","Behavioral Assessment Method Index","Development of Upper Extremity Behavioral Assessment Methods for Reach-and-grasp and Physical Rehabilitation.","BAM","Inclusion Criteria:\n\n* Between 8 and 36 months old at baseline\n* Full Term Birth (37 to 41 weeks gestation)\n* Healthy development (meeting age-appropriate milestones)\n\nExclusion Criteria:\n\n* Diagnosed or suspected impairments (auditory, visual, cognitive or motor)","4 Months","36 Months",{"count":429,"type":23},80,"The overall goal of this study is to develop and improve assessment methods for children with and without perinatal arterial ischemic stroke (PAS)\u002Fhemiparetic cerebral palsy (HCP). The focus is on behaviors of the arms and hands and includes other domains of child development like fine motor, gross motor, language, cognition, and social-emotional skills. This study involves 1) the use of data, including video recordings, from \"I-ACQUIRE - Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation\" (NCT03910075) and 2) a prospective longitudinal observational data collection with a typically developing cohort using a comprehensive assessment battery (play, fine motor, gross motor, language, cognition, and social emotional skills). The current study is called the BAM Index. No intervention or treatment is provided as part of the BAM Index. The I-ACQUIRE study is an RCT that includes an intervention. The BAM index study is a use of data from the I-ACQUIRE cohorts and a prospective observational study of a typically developing cohort (children without stroke or cerebral palsy) over time. The results of this work will develop, test, refine, and validate a new methodology based on reach-and-grasp and other behaviors related to child development that will have profound and lasting impact on assessment and selection of treatment strategies for pediatric physical rehabilitation of children. The use and reuse of video technology is also well-suited to remote or virtual assessment. This proposal will add to our current knowledge by 1) yielding a psychometrically robust and alternative approach to measuring upper extremity function in children with stroke and\u002For hemiparetic cerebral palsy and 2) defining specific parameters about how to promote closer-to-normal upper extremity function in children with motor disability.",[28,432,433,340],"Perinatal Stroke","Hemiparesis","2025-12-05",{"date":408,"type":38},{"date":437,"type":38},"2023-07-07",{"date":439,"type":23},"2026-06",{"name":441,"class":45},"Ohio State University",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":83,"minAge":449,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":118,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":46},"100517478","investigating-fit-and-satisfaction-of-the-prone-positioner-100517478","NCT06018064","Investigating Fit and Satisfaction of the Prone Positioner","Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study","Inclusion Criteria:\n\n* Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy with tracheostomies between the ages of \\>44 weeks gestational age to 24 months of age with various size\u002Fweights of infants.\n* Any race\u002Fethnicity\n* English speaker\n* Males and females\n* Caregivers\n* Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device.\n\nExclusion Criteria:\n\n* Infants \\> 24 months of age\n* Infants medically unstable as determined by attending physician in the PICU\u002FNICU or Vent Clinic\n* Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.\n* Infants with weightbearing restrictions\u002Ffractures in their upper extremities.\n* Non-English speakers \\* Wards of the state","44 Weeks","24 Months",{"count":452,"type":23},30,[120],"The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\\[s\\] it aims to answer are:\n\n* What is the fit and satisfaction of the device?\n* Does the device fulfill the goal of allowing infants with trachs participate in tummy time\n* What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.\n\nParticipants will be placed in the Prone Positioner, they will be monitored for their comfort\u002Fsatisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts\u002Fsuggestions for the Prone Positioner.",[28],"2025-12-01",{"date":434,"type":38},{"date":459,"type":38},"2023-09-21",{"date":461,"type":23},"2028-09",{"name":463,"class":45},"Children's Mercy Hospital Kansas City",{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":475,"conditions":476,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":46},"100576390","maternal-abdominal-morphology-assessment-100576390","NCT06784674","Maternal Abdominal Morphology Assessment","Diabetes Prediction During Pregnancy Using Pancreas MRI","MAMA","Inclusion Criteria:\n\n* Pregnant women, with a singleton gestation\n* Age 18 - 54 years at screening\n* Gestational age \\\u003C 14 weeks\n* Willing to commit to 1 year postpartum follow up\n* Planning to remain in geographical vicinity of Austin for 1 year after delivery\n\nExclusion Criteria:\n\n* Presence of any mechanically or magnetically activated implants\n* Claustrophobia\n* Other contraindication for MRI\n* BMI ≥ 38.0 or maximum width less than 48 cm (necessary to fit within the MRI field of view)","54 Years",{"count":474,"type":23},87,"Previous studies have shown that pancreas size tends to be smaller in individuals with diabetes compared to those without diabetes. The investigators have recently found that pancreas size increases during pregnancy. The MAMA study aims to examine changes in the pancreas that occur during pregnancy, in both pregnant mothers and their babies, and find out how they are affected by maternal diabetes.\n\nThe MAMA study is a prospective cohort study that will follow women and their babies through pregnancy and one year postpartum. Women aged 18-54, who are under 14 weeks pregnant are being recruited to participate in the MAMA study.",[477,28,478,479],"Pregnancy Related","Pancreas","Diabetes",[481,478,479],"Pregnancy","2025-10-20",{"date":484,"type":38},"2025-10-22",{"date":486,"type":38},"2025-05-06",{"date":488,"type":23},"2031-12",{"name":490,"class":45},"University of Texas at Austin",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":17,"sex":83,"minAge":498,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":46},"100387166","panda-gym-automated-assessment-of-neurodevelopment-in-infants-at-risk-for-motor-disability-100387166","NCT04321200","PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability","Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability","Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded).\n\n* Infants with early brain injury (EBI):\n\n  * Hydrocephalus\n  * Hypoxic-ischemic encephalopathy (HIE)\n  * Periventricular leukomalacia (PVL)\n  * Intraventricular hemorrhage (IVH)\n  * Stroke\n* Healthy infants (controls):\n\n  o No history of early brain injury (EBI)\n* Infants without EBI\u002Frisk for future disability:\n\n  * Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.","0 Months","6 Months",{"count":501,"type":23},1700,"Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.",[504,28,505],"Pediatric ALL","Neurodevelopmental Disorders",[351,234,507,508,509,510,511,512],"Developmental Delays","Electronics","Early Intervention","Sensory and Motor","NICU","Natural Play","2025-09-22",{"date":515,"type":38},"2025-09-23",{"date":517,"type":38},"2020-11-01",{"date":519,"type":23},"2026-07-01",{"name":521,"class":45},"University of Pennsylvania",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":17,"sex":83,"minAge":498,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":118,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":107},"100552914","talk-with-me-baby-to-enhance-the-early-home-language-environment-100552914","NCT06479278","Talk With Me Baby to Enhance the Early Home Language Environment","Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment for Rural and Underserved Children","TWMB","Inclusion Criteria:\n\nFor this study, each child-caregiver dyad will consist of:\n\n1. A caregiver who will receive TWMB during routine WCC visits for their child at participating clinics, and\n2. The child of the above caregiver for whom the WCC visits are conducted.\n\nA potential caregiver participant must meet all the following inclusion criteria to enroll in the study:\n\n1. Be the age of majority, or older, as defined by the state of residency.\n2. Able to complete study measures in English.\n3. Have the legal authority to consent to participate for themselves and to consent on behalf of their child.\n\nTo proceed to the follow-up portion of the study the caregiver (dyad) must have a LENA baseline assessment score that is ≤ 75th percentile compared to a child's age-referenced normative data.\n\nA potential child participant must meet all the following inclusion criteria to be enrolled in the study:\n\n1. Receive WCC at a participating clinic from a participating provider.\n2. Be zero to nine months (+ 0-30 days) old at enrollment.\n3. Was born at full term (\\> 37 weeks gestation).\n4. Was born in a singleton birth (i.e., was the only child delivered during the birth).","9 Months",{"count":532,"type":23},66,[120],"The goal of this clinical trial is to learn if the Talk With Me Baby (TWMB) program improves the home-language environment for at-risk families with children ages two to six months when primary care providers deliver the program during well-child checkups. The main question it aims to answer is:\n\nWill the TWMB program increase the time a caregiver talks to their infant?\n\nParticipants will:\n\n1. Come to at least four well-child checkups\n2. Receive the TWMB program from the provider during the checkups\n3. Record their conversations with their infant before they receive the program and after they receive the program four times.",[183,536,28,537,538,539],"Speech","Infant Behavior","Language, Child","Language","2025-08-27",{"date":542,"type":38},"2025-08-29",{"date":544,"type":38},"2025-02-03",{"date":546,"type":23},"2026-08-31",{"name":548,"class":549},"IDeA States Pediatric Clinical Trials Network","NETWORK",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":17,"sex":83,"minAge":557,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":118,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":160,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":46},"100559826","cue-based-vs-clinician-driven-feeding-in-very-low-birthweight-infants-100559826","NCT06569186","Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants","Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial","Inclusion criteria:\n\n* Birthweight \\\u003C 1500 grams\n* Gestational age between 28 and 31 weeks of gestation\n* Full enteral feeding established before 32 weeks of postmenstrual age (PMA)\n* Oral feeding initiated before 33 weeks PMA.\n\nExclusion criteria:\n\n* Major congenital\u002Fchromosomal anomalies,\n* Patent ductus arteriosus causing significant cardiovascular symptoms\n* History of necrotizing enterocolitis stage 2 or greater","28 Weeks","32 Weeks",{"count":560,"type":23},74,[120],"In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.",[564,28,565],"Infant, Very Low Birth Weight","Feeding Patterns","2025-08-14",{"date":568,"type":38},"2025-08-15",{"date":570,"type":23},"2026-12",{"date":572,"type":23},"2028-10",{"name":389,"class":45},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":83,"minAge":582,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":118,"phases":585,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":602,"locationsCount":46},"100599223","walnuts-as-an-infant-solid-food-for-health-100599223","NCT07081698","Walnuts as an Infant Solid Food for Health","Walnut as a First Food During Complementary Feeding on Gut Microbiota and Immunity Development in Breastfed Infants","WISH","Inclusion Criteria:\n\n* Full term: gestational age ≥ 37 weeks\n* Generally healthy without conditions that would affect normal growth\n* No significant consumption of complementary food (e.g., no more than 1 oz of solid foods per week)\n* Exclusively breastfed (\\\u003C 2 weeks of cumulative formula exposure)\n\nExclusion Criteria:\n\n* Adults unable to consent\n* Pregnant women\n* Prisoners","5 Months",{"count":584,"type":23},90,[120],"The objective is to investigate the effect of walnuts on gut microbiota, inflammatory markers, atopic dermatitis status, and indices of allergy outcomes in breastfed infants during early complementary feeding.\n\nThe three primary aims include:\n\nAim 1: Evaluate the effect of walnut consumption on gut microbiota structure and function, inflammation, atopic dermatitis, and allergy outcomes.\n\nAim 2: Evaluate the impact of walnut consumption on infant growth trajectories and risk of overweight.\n\nAim 3 (exploratory): Identify walnut-specific food signatures that are associated with gut microbiota and immunity biomarkers using a novel nutri-metabolomics technique.",[588,589,28],"Gut -Microbiota","Inflammatory Markers",[591,592,127,593,594,595],"Walnut","Microbiome","Pediatric","Nutrition","Health","2025-07-16",{"date":598,"type":38},"2025-07-23",{"date":600,"type":38},"2025-05-18",{"date":214,"type":23},{"name":603,"class":45},"Colorado State University",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":17,"sex":83,"minAge":4,"maxAge":611,"enrollmentInfo":612,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":46},"100541642","infant-crying-a-bioacoustic-prognostic-signal-for-neurodevelopment-100541642","NCT06332521","Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment","BABYCRY_1000","Inclusion Criteria:\n\n* For a full-term baby \\> 37 weeks\n* For a premature baby \\\u003C 37 weeks\n* Born in the maternity ward of the Saint-Etienne University Hospital\n* Holder of parental authority having received informed information about the study and their right to object\n* Holder of parental authority affiliated to or beneficiary of a social security system\n* Eutrophic between the 10th and 90th percentile on the neonatal curves)\n\nExclusion Criteria:\n\n* Refusal of participation by the holder of parental authority\n* Antenatal pathology, nor perinatal asphyxia\n* Holder of minor parental authority\n* Holder of parental authority under curatorship or guardianship\n* Abnormal T1 audiological screening test.","4 Days",{"count":613,"type":23},1100,"Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.\n\nCrying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry.",[616,617,28],"Newborn; Vitality","Premature Infants",[619,620],"Newborn","Crying","2025-05-22",{"date":623,"type":38},"2025-05-28",{"date":625,"type":38},"2024-03-20",{"date":627,"type":23},"2028-03-01",{"name":629,"class":45},"Centre Hospitalier Universitaire de Saint Etienne",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":17,"sex":83,"minAge":637,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":46},"100558371","babies-brain-responses-to-strangers-100558371","NCT06550245","Babies' Brain Responses to Strangers","The Malleability of Social Group Understanding in Infancy and Early Childhood","Inclusion Criteria:\n\n* typically developing\n* age 7 to 12 months\n* at least 37 weeks gestation\n\nExclusion Criteria:\n\n* any known developmental delays\n* less than 37 weeks gestation","7 Months","12 Months",{"count":640,"type":23},100,"Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds.",[28],"2025-03-03",{"date":645,"type":38},"2025-03-06",{"date":647,"type":38},"2024-07-23",{"date":649,"type":23},"2025-10",{"name":651,"class":45},"University of California Santa Cruz",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":17,"sex":83,"minAge":4,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":118,"phases":662,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":674,"locationsCount":46},"100499272","investigating-baby-behavior-and-family-technology-use-study-100499272","NCT05781100","Investigating Baby Behavior and Family Technology Use Study","Maternal Technology Use During Feeding and Infant Self-Regulation and Growth","iBaby","Eligibility Criteria\n\nAt the time of recruitment, eligibility criteria for participants will include:\n\n* 18 years of age or older\n* In 3rd trimester of singleton pregnancy\n* History of healthy, low-risk pregnancy\n* Lives within 50 miles of the Cal Poly campus\n* Owns a mobile device\n\nAfter the child is born, eligibility criteria for participants will remain in the study will include:\n\n* Infant was born term (gestational age ≥37 weeks) Exclusion criteria include\n* Mother has an untreated medical or psychiatric condition (e.g. bipolar disorder) that could impede study participation or affect mother-infant interaction\n* Mother is participating in another interventional study that influences parenting, mother-infant interactions, feeding practices, or technology use\n* The mother is unwilling or unable to commit to longitudinal follow-ups of herself or her child\n* Infant was born preterm (gestational age \\\u003C37 weeks)\n* Infant diagnosed with fetal abnormality or medical condition that interferes with oral feeding (e.g., feeding disorder, milk protein allergy) or development\n* Infant diagnosed with developmental delay (e.g., Down's syndrome)",{"count":661,"type":23},345,[120],"Maternal sensitivity and contingent responsiveness to infant behavioral cues is an important contributor to infants' developing capacities to self-regulate. During early infancy, feeding interactions comprise a significant portion of mother-infant dyadic interactions and high-quality feeding interactions provide both nutritive and socioemotional benefits; recent data suggest that, for many dyads, mothers' sensitive responsiveness during feeding interactions is routinely impacted by the omnipresence of portable technology. The objective of the proposed research is to better understand the development and possible impacts of maternal technology use on infant feeding interactions, emotion and intake regulation, and sociobehavioral and growth outcomes.",[665,314,28,666,667],"Mobile Phone Use","Self-Regulation, Emotion","Self-Regulation","2025-02-21",{"date":670,"type":38},"2025-02-24",{"date":672,"type":38},"2023-01-16",{"date":265,"type":23},{"name":675,"class":45},"California Polytechnic State University-San Luis Obispo",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":17,"sex":83,"minAge":684,"maxAge":685,"enrollmentInfo":686,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":688,"conditions":689,"keywords":692,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":46},"100537525","families-filming-infants-learning-movement-100537525","NCT06278961","Families Filming Infants Learning Movement","The Ontogeny of Fidgety Movements in Infants At High-Risk of Cerebral Palsy","FILM","Inclusion Criteria:\n\n* Infants born full-term with typical development, bithweight \\>2500g\n* Infants with a history of brochopulmonary dysplasia, defined as having a preterm birth (\\\u003C33 weeks gestational age) and requiring supplemental oxygen beyond 36 weeks gestational age\n* Infants with neonatal encephalopathy, who required hypothermic cooling treatment\n* Infants born \\\u003C36 weeks gestational age\n* Infants born in a multiple gestation pregnancy\n* Infants with a diagnosis of Trisomy 21\n* Infants born and diagnosed with SMA prenatally, via newborn screening assessment or prior to 10 weeks corrected age\n* Infants are less than 10 weeks corrected age at time of enrollment\n\nExclusion Criteria:\n\n* Children who are enrolled in DCFS custody\n* Parent or infant guardian does not have a smartphone","10 Weeks","20 Weeks",{"count":687,"type":23},350,"The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants.",[28,340,690,691],"Motor Disorders","Neurological Disorder",[693,694,695],"fidgety movements","general movement assessment","cerebral palsy","2025-02-11",{"date":698,"type":38},"2025-02-13",{"date":700,"type":38},"2021-01-28",{"date":702,"type":23},"2026-09-30",{"name":704,"class":45},"Ann & Robert H Lurie Children's Hospital of Chicago"]