[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurodevelopment-outcome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurodevelopment-outcome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,76,107,138,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100638001","thyroxine-supplementation-in-small-for-gestational-age-sga-infants-with-birth-weight-1500g-and-tsh-6-20-miuml-100638001",false,"NCT07625722","Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Inclusion Criteria:\n\n* Preterm infants born Small for Gestational Age (SGA) with a birth weight \\\u003C 1500g；\n* Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；\n* Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU\u002FmL；\n* Written informed consent obtained from the parents.\n\nExclusion Criteria:\n\n* Diagnosis of Congenital Hypothyroidism (CH) with serum TSH \\> 20 mIU\u002FmL within the first 2 weeks of life and receiving L-T4 treatment;\n* Persistent serum TSH \\\u003C 6 mIU\u002FmL throughout the first 2 weeks;\n* Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;\n* Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;\n* Presence of major congenital malformations of vital organs or known chromosomal\u002Fgenetic disorders;\n* History of maternal thyroid disease or maternal use of thyroid-related medications.","ALL","2 Weeks",{"count":19,"type":20},106,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug\u002Fkg\u002Fd, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights \\\u003C 1500g and TSH levels between 6 and 20 mIU\u002Fml. Preterm infants in the intervention group will receive 8 ug\u002Fkg\u002Fd of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.",[26,27,28,29],"Thyroid Function","Preterm","SGA and Growth","Neurodevelopment Outcome","NOT_YET_RECRUITING","2026-05-29",{"date":33,"type":34},"2026-06-04","ACTUAL",{"date":36,"type":20},"2026-06-20",{"date":38,"type":20},"2029-06-20",{"name":40,"class":41},"Shandong Provincial Hospital","OTHER_GOV",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":52,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"100639413","antenatal-vs-postnatal-transport-team-positioning-in-extremely-preterm-outborn-infants-100639413","NCT07580859","Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants","A Prospective French National Study of the Impact of Antenatal Versus Postnatal Positioning of a Neonatal Transport Team on Survival and Severe Neurodevelopmental Delay at Two Years in Outborn 23-28 Weeks Infants : outbornTRANSFER Study Protocol","OutbornTRANSF","Eligible for inclusion are infants for whom an antenatal call to the emergency medical service (SAMU) was initiated due to prematurity (imminent delivery and infant alive at the time of the call) and who:\n\n* Were born outside a level 3 maternity hospital (outborn birth) in mainland France\n* Have a gestational age at birth between of 23+0 - 28+6\n* Have parents who speak and understand French (required for telephone follow-up) To assess parent-related outcomes, parents will also be included in the study if their infant is eligible and if they have not objected to participation.\n\nInfants will not be included if one or both parents are unable to speak and understand French, if at least one of the parents is opposed to inclusion, if they had lethal congenital malformations or if they were born outside hospital (accidental premature home births).","0 Days","28 Months",{"count":54,"type":20},627,"OBSERVATIONAL","The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care).\n\nThis project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age.\n\nStudy will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care.\n\nIf parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents.\n\nThrough a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.",[58,29,59],"Prematurity Complications","Prematurity",[59,61,62,63,64,65],"Outborn","Transport","Mortality","Cohort study","Neurodevelopment","2026-05-26",{"date":68,"type":34},"2026-05-28",{"date":70,"type":20},"2026-06",{"date":72,"type":20},"2030-09",{"name":74,"class":75},"Assistance Publique - Hôpitaux de Paris","OTHER",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100628113","implementation-outcomes-and-cost-effectiveness-of-developmental-monitoring-for-children-exposed-to-hiv-100628113","NCT07457411","Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV","IMPLEMENT","Inclusion Criteria:\n\n* Healthcare workers (HCW): age 18 years or older\n* HCW: working at one of the clinics engaged in the study caring for children at routine clinic appointments\n* Children: age 16-24 months\n* Children: attending routine clinic appointment at one of the clinics engaged in the study\n* Caregivers: age 18 years or older\n* Caregivers: caregiver of child eligible for participation\n\nExclusion Criteria:\n\n* None",true,"16 Months",{"count":86,"type":20},5000,[23],"The goal of this study is to learn about how to best carry out neurodevelopmental screening methods (tests to see if a young child can use support with brain development) in routine clinic visits in Botswana and Kenya among children age 16-24 months old.\n\nThe main questions it aims to answer are: 1. when used in routine clinic visits by healthcare workers, how many children are able to get screened; 2. are the screening tools appropriate and how can they best be used; 3. how much time and money does it take to use the screening methods?\n\nThe investigators will compare two screening methods chosen by healthcare workers at the beginning of the study. Children will undergo a brief test of their brain development to see if they need further evaluation and support. Caregivers will be asked to complete a short survey to see what they thought of the screening test. Healthcare workers will complete brief surveys and interviews to see what they thought of carrying out the screening tests and how use of the screening tests can be improved in their clinics.",[90,65,29],"Neurodevelpmental Delays",[92,93,94,95,96,97],"Implementation science","Neurodevelpment","Neurodevelopmental delays","Neurodevelopmental screening","Neurodevelopmental outcome","High HIV prevalence settings","2026-03-02",{"date":100,"type":34},"2026-03-09",{"date":102,"type":20},"2027-01",{"date":104,"type":20},"2028-03",{"name":106,"class":75},"University of Washington",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":42},"100621613","impact-of-hospital-to-home-optimizing-preterm-infant-environment-for-surgical-neonates-and-their-parents-h-hope-100621613","NCT07372898","Impact of Hospital to Home: Optimizing Preterm Infant Environment for Surgical Neonates and Their Parents (H-HOPE)","Impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) Intervention on Infants With Congenital Defects Requiring Neonatal Surgery and Their Parents.","H-HOPE","Inclusion criteria:\n\n* Infants and one or both of their parents, born with a congenital defect and requiring major surgery during the neonatal period, including congenital heart disease.\n* At the time of H-HOPE initiation, infants must be \\\u003C48 weeks post-menstrual age (PMA), clinically stable (no vital sign instability during routine nursing care) on respiratory support \\\u003C a nasal cannula at 2 liters per minute, and off all intravenous (IV) pain medications.\n\nExclusion criteria:\n\n* Infants born at \\\u003C34 weeks gestation,\n* Infants born with congenital defects involving the nervous system (i.e., spina bifida, congenital hydrocephalus),\n* Infants with genetic syndromes,\n* Infants with a history of Extracorporeal Membrane Oxygenation,\n* Infants with a history of mechanical ventilation lasting 30 or more days, or\n* Infants that are wards of the state.","1 Week","8 Weeks",{"count":118,"type":20},40,[23],"Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes.\n\nEarly relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standard ICU care for infants born with a congenital defect requiring neonatal surgery, and their parents. The main questions to be answered include:\n\n1. Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery?\n2. Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery?\n3. Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery?\n4. Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents?\n5. Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents?\n6. Do parents of infants born with congenital defects requiring surgery experience participating in the H-HOPE intervention positively?\n\nResults of this study may provide preliminary evidence supporting use of H-HOPE to positively impact short- and long-term outcomes for these infants and their parents.",[122,29],"Oral Feeding Outcomes",[113,124,125,126,127],"Infant","Surgical","Congenital defect","Neonatal intensive care","RECRUITING","2026-01-20",{"date":131,"type":34},"2026-01-28",{"date":133,"type":34},"2025-07-31",{"date":135,"type":20},"2027-03-30",{"name":137,"class":75},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":83,"sex":146,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":153,"conditions":154,"keywords":160,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":42},"100595194","phase-3-the-mom-care-trial--evaluating-antenatal-and-postnatal-mmsplus-for-improved-infant-birth-and-growth-outcomes-100595194","NCT07029282","The MOM-CARE Trial : Evaluating Antenatal and Postnatal MMSPlus for Improved Infant Birth and Growth Outcomes","A Phase III Double-Blind, Adaptive Randomized Trial of Antenatal MMSPlus Versus UNIMAPP MMS and Postnatal MMSPlus Versus UNIMAPP MMS or IFA to Improve Infant Birth Outcomes and Growth at 6 Months","MOM-CARE","Antenatal Phase::\n\nInclusion Criteria:\n\n* Gestational age confirmed by ultrasound to be 8-14 weeks\n* Singleton and viable fetus on ultrasound\n* A resident of the catchment area for at least the last six months\n* Plans to stay within the catchment area during the pregnancy duration, during delivery and after birth of the baby.\n* Has provided voluntary written informed consent\n\nExclusion Criteria:\n\n* Women with known allergies or intolerance to any components of the MMS or MMS PLUS being studied\n* Women with pre-existing health conditions such as history of uncontrolled diabetes and hypertension or other chronic illnesses\n* Substance abuse, such as recreational drugs or smoking tobacco. Women chewing tobacco will not be excluded.\n\nPostnatal Phase::\n\nInclusion Criteria:\n\n* Birth weight available within 72 hours\n* Intention to breastfeed for 6 months\n* Resides in the study area for the duration of the trial\n* Has provided voluntary written informed consent\n\nExclusion Criteria:\n\n* Congenital anomalies, birth defects, or severe neonatal complications\n* Infants who are already receiving supplemental formula feeding or other nutritional supplements (except pre-lacteal feeding, vitamins, and medications)\n* Infants whose mothers have conditions that significantly affect breastfeeding, such as severe postpartum depression, insufficient milk supply, or maternal use of medications that contraindicate breastfeeding","FEMALE","15 Years","49 Years",{"count":150,"type":20},3000,[152],"PHASE3","This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life.\n\nThe main questions it aims to answer are:\n\n1. Does MMS Plus during pregnancy reduce the risk of poor infant outcomes compared to standard MMS, as measured on a 5-point ordinal scale ranging from perinatal mortality to term birth with appropriate, small, or large-for-gestational-age infants?\n2. Does postnatal MMS Plus improve infant length velocity at 6 months of age among exclusively breastfed infants compared to standard MMS and iron\u002Ffolic acid (IFA) supplementation?\n\nResearchers will compare:\n\n1. MMS Plus versus standard MMS during pregnancy (antenatal phase)\n2. MMS Plus versus standard MMS versus IFA after birth (postnatal phase)\n\nParticipants will:\n\n1. Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy\n2. Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period\n3. Receive supplements under double-blind conditions\n4. Be followed through childbirth and until the infant is 6 months of age\n5. Attend regular clinic visits for health monitoring, infant assessments, and data collection.\n\nThis phase III adaptive randomized controlled trial will occur in three peri-urban catchment areas of Karachi, Pakistan.",[155,156,157,158,159,29],"Newborn Health","Multiple Micronutrient Deficiencies During Pregnancy","Nutrition During Pregnancy","Adaptive Trial","Postnatal Growth",[161,162,163,164],"Antenatal Phase","Postnatal Phase","Micro Nutrient Supplementation","Infant Growth","2025-10-01",{"date":167,"type":34},"2025-10-07",{"date":169,"type":34},"2025-07-08",{"date":171,"type":20},"2027-12-31",{"name":173,"class":75},"Aga Khan University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":186,"studyType":55,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":42},"100606970","turkish-version-of-the-brief-hammersmith-infant-neurological-examination-hine-100606970","NCT07182474","Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE)","Turkish Version of the BRIEF-Hammersmith Infant Neurological Examination (HINE) With High-Risk of Infants: A Study of Validity and Reliability","BRIEF-HINE","Inclusion Criteria:\n\n* Infants with high risk of CP: Periventricular hemorrhage, intracranial hemorrhage grade 2, 3, 4, cystic PVL, stage 3 hypoxic ischemic encephalopathy, neonatal bilirubin encephalopathy (kernicterus), perinatal stroke, perinatal asphyxia, respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and infants receiving long-term O₂ support, sepsis due to gram-negative bacteria, necrotizing enterocolitis (NEC), infantile apnea, those with a low 5-minute Apgar score (3 and below), those diagnosed with intrauterine growth retardation, multiple births (twins, triplets), preterm infants with retinopathy of prematurity (ROP), infants with prolonged severe hypoglycemia and hypocalcemia, (small for gestational age (SGA), less than the 3rd percentile) or large for gestational age (large for gestational age (LGA), less than the 97th percentile). (large) babies, babies receiving mechanical ventilation for more than 24 hours, babies born at less than 32 weeks of gestation and weighing less than 1500 grams.\n\nExclusion Criteria:\n\n* Infants with any known orthopedic, systemic disease or neurological diagnosis other than CP","3 Months","12 Months",{"count":185,"type":20},120,"1 Year","The American Academy of Pediatrics defines high-risk infants as those with preterm birth, special health care needs, family risk factors, and those at risk of early death. Factors such as premature birth, perinatal asphyxia, hypoxic-ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), chronic lung disease, seizures, meningitis, hyperbilirubinemia, twin\u002Ftriplet pregnancy, and intrauterine growth restriction are risk factors that can result in morbidity and mortality in infants. Regular neurological examinations and neuromotor tests are necessary for at-risk infants to identify developmental problems early and to initiate early intervention programs.In developing countries, regular follow-up and early rehabilitation of at-risk infants are not successfully implemented. 5,6 The lengthy test batteries and busy clinics are among the most significant reasons. Therefore, the development and dissemination of shorter, valid, and reliable tests is of great importance. The Hammersmith Neonatal Neurological Examination (HINE), one of the gold standard methods, consists of 26 items and takes 15-20 minutes to administer.Due to the number of items and the duration, it is not frequently used routinely. In response to this clinical need, the HINE short scale was developed in 2024.The aim of the study is to have a Turkish version of the Abstract-HINE test in Turkey and to study its validity and reliability in high-risk infants.",[189,190,29],"Pediatrics","Neurological Abnormality","2025-09-18",{"date":193,"type":34},"2025-09-19",{"date":195,"type":34},"2025-08-22",{"date":197,"type":20},"2026-10-30",{"name":199,"class":75},"Kahramanmaras Sutcu Imam University"]