[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-for-gestational-age-at-delivery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-for-gestational-age-at-delivery":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,63,92,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100609997","phase-3-trial-investigating-the-efficacy-and-safety-of-weekly-lonapegsomatropin-compared-to-daily-somatropin-in-children-and-adolescents-with-short-stature-or-growth-failure-due-to-growth-hormone-sufficient-disorders-100609997",false,"NCT07221851","Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders","A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature","Inclusion Criteria:\n\n1. Chronological age between ≥2 and \\\u003C18 years, at start of screening.\n2. Naïve to growth hormone and growth hormone promoting therapies.\n3. Prepubertal.\n4. Able to stand without assistance.\n5. Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:\n\n   TS or SHOX-D (Léri-Weill dyschondrosteosis):\n   1. Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.\n   2. Impaired growth or short stature defined as:\n\n   (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States\n\n   SGA without catch-up growth:\n\n   c. Birth weight and\u002For birth length \\\u003C -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used.\n\n   d. Impaired growth or short stature defined as: (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height \\\u003C -2.5 SDS for age and sex according to the for children ≥ 2 years and \\\u003C 3 years\n\n   ISS:\n\n   e. Height \\\u003C -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature.\n\n   f. Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS \\>0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.\n6. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.\n7. Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB\u002FHREC\u002FIEC.\n\nExclusion Criteria:\n\n1. Advanced bone age X-ray by central reading defined as \\>20% above chronological age in months (Greulich 1959).\n2. Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.\n3. Current clinical diagnosis of diabetic retinopathy\n4. Any diagnosis or presence at screening of the following:\n\n   1. Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.\n   2. Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.\n5. Signs\u002Fsymptoms of intracranial hypertension, active proliferative retinopathy.\n6. Uncontrolled hypo- or hyperthyroidism.\n7. Uncontrolled diabetes mellitus (defined as: HbA1c \\>7.5% from central laboratory at screening).\n8. Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and\u002For cardio-thoracic surgery due to their independent effects on growth.\n9. Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2).\n10. Undiagnosed or uncontrolled hypertension.\n11. Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit\u002Fhyperactivity disorder (ADHD).\n12. High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.\n13. Female who is pregnant, plans to be pregnant, or breastfeeding.\n14. Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.\n15. Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.\n16. Exclusion Criteria only applicable to TS:\n\n    1. Presence of Y chromosome material on genetic testing without history of gonadectomy.\n    2. Less than 10% of 45,X mosaicism.\n    3. Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.\n17. Exclusion Criteria only applicable to SGA:\n\n    a. Any known clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements: (i.)Chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors.\n\n    (ii.)Congenital abnormalities (causing skeletal abnormalities), including but not limited to skeletal dysplasias.\n18. Exclusion Criteria only applicable to ISS:\n\n    1. Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.","ALL","2 Years","17 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\\u003C18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.",[27,28,29,30],"Turner Syndrome","Short Stature Homeobox Gene Mutation","Idiopathic Short Stature","Small for Gestational Age at Delivery",[27,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,28,49,29],"Noonan Syndrome","Growth Hormone","Short Stature","Growth Failure","Sex Chromosome Disorders","Chromosome Disorders","Endocrine System Diseases","Pituitary Hormones, Anterior","Pituitary Hormones","Hormones","Hormone Substitutes","Human Growth Hormone","Lonapegsomatropin","Sex Chromosome Disorders of Sex Development","Impaired Growth","somatropin","Growth Hormone Sufficiency","Short Stature Children Born Small for Gestational Age","RECRUITING","2026-06-19",{"date":53,"type":54},"2026-06-23","ACTUAL",{"date":56,"type":54},"2025-12-12",{"date":58,"type":21},"2029-03",{"name":60,"class":61},"Ascendis Pharma A\u002FS","INDUSTRY",25,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100533456","growing-little-peapods-study-100533456","NCT06226051","Growing Little PEAPODS Study","Growing Little PEAPODS Study: Association Between Prematurity and Body Composition, Nutrition Practices, and Neurodevelopmental Outcomes","Neonate Inclusion Criteria:\n\n* Born inpatient at Meriter Hospital, Inc. at or above 22 gestational weeks. Upper limit is 32 weeks 6 days GA (possible gestational age range from 22w0d-32w6d)\n\nNeonate Exclusion Criteria:\n\n* Known genetic condition that impacts neurodevelopmental outcomes or brain structure development\n* Multiple major congenital anomalies\n* Per the investigator's opinion, the subject will likely require transfer to American Family Children's Hospital (AFCH) before 36 weeks PMA\n\n  * Any neonate who enrolls in the study and then unexpectedly requires transfer to AFCH before 36 weeks PMA will be excluded from the study if they are unable to obtain at least one body composition measurement before transfer. Body composition data points can only be collected at Meriter Hospital due to the location of PEAPOD\n\nBirthing Parent Inclusion Criteria:\n\n* Birthing parent must speak English or Spanish due to consent documents\n* Able to understand and willing to sign a written informed consent document\n* Primary caregiver of a neonate who is eligible to participate in the study\n* Agrees to enroll neonate into the study\n* Willing to comply with all study procedures and be available for the duration of the study\n* Age 15 or older\n\nBirthing Parent Exclusion Criteria:\n\n* Subject is unable to provide informed consent, including subjects in foster care and subjects within state custody\n* Does not plan to maintain custody of the child after birth, such as in instances of adoption or surrogacy","22 Weeks","32 Weeks",{"count":73,"type":21},120,"OBSERVATIONAL","The goal of this clinical trial is to learn more about how the food and nutrition babies receive while in the Neonatal Intensive Care Unit (NICU) influences their ability to gain weight and fat-free mass, and their future growth and development.\n\nParticipants will:\n\n* have body growth measurements collected using the PEAPOD device\n* have nutritional information collected, and\n* be followed for neurodevelopmental outcomes\n\nParticipants can expect to be in the study for 36 months.",[77,78,79,80,30],"Premature Birth","Premature Infant","Premature","Intrauterine Growth Restriction","2025-08-07",{"date":83,"type":54},"2025-08-12",{"date":85,"type":54},"2024-09-04",{"date":87,"type":21},"2028-01",{"name":89,"class":90},"University of Wisconsin, Madison","OTHER",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100565710","neuromotor-development-and-motor-related-health-care-in-children-with-a-high-risk-neonatal-period-100565710","NCT06645717","Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period","Neuromotor Development in Children Enrolled in the Swedish Neonatal Follow-up Program and Access to Motor Related Healthcare","Inclusion Criteria:\n\n* Included in the SNQ registry and having a follow-up protocol for 2 and\u002For 5 years of age.\n\nExclusion Criteria:\n\n* None if the above inclusion criteria ar true.","14 Years",{"count":101,"type":21},2900,"The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.",[104,105,77,106,107],"Motor Disorders","Neurodevelopmental Disorders","Hypoxic-Ischemic Encephalopathy","Small for Gestational Age At Delivery",[109,110,111,112,113,114,115,116],"brain","HIE","SGA","preterm","neurodevelopment","motor related healthcare","children","motor function","NOT_YET_RECRUITING","2024-10-14",{"date":120,"type":54},"2024-10-17",{"date":122,"type":21},"2025-01-01",{"date":124,"type":21},"2034-10-01",{"name":126,"class":90},"Karolinska Institutet",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":16,"minAge":4,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100417821","bioimpedence-and-arterial-function-monitoring-at-birth-and-in-infants-100417821","NCT04720690","Bioimpedence and Arterial Function Monitoring at Birth and in Infants","Bioimpedence and Arterial Function Monitoring at Birth and in Infants: the BAMBI Study","BAMBI","Inclusion Criteria:\n\n* Healthy term infants (including those with SGA+\u002F-FGR) in the postnatal ward\n* Term and Preterm infants (including those with SGA+\u002F-FGR) admitted to the neonatal unit\n* Written informed parental consent\n\nExclusion Criteria:\n\n* Antenatal or postnatal diagnosis of complex\u002Flife-limiting congenital anomaly or genetic condition\n* Infants with no realistic chance of survival\n* Infants with fragile skin not permitting use of cuffs for research purposes\n* Babies whose parents have a limited understanding of English will be excluded in the event that communication via NHS translation services is not possible due to clinical demands on these services",true,"6 Months",{"count":73,"type":21},"Babies may be born appropriately grown for gestational age (AGA, \\>10th centile) or small for gestational age (SGA, \\\u003C10th centile). Babies who are SGA and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (FGR). Babies with FGR are at increased risk of cardiovascular disease in adult life. Increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. It is not known how early in life these changes can be robustly detected. In addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by SGA or not. This study aims to understand if there are differences in cardiac and arterial structure and function between babies born AGA or SGA. Within the group of SGA babies, the study team will investigate whether FGR and maternal pre-eclampsia influence these measurements. The effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \\\u003C32 weeks gestational age (GA), and half will be ≥32 weeks GA. Study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. The study team will use the Vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. The Vicorder will also be used to measure cardiac output. The feasibility and validity of this device for this purpose will be investigated (Vicorder is not validated for cardiac output measurement in infants). Vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the NICaS monitor). The study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.",[140,141,30,142],"Arterial Stiffness","Fetal Growth Retardation","Pre-Eclampsia","2024-07-26",{"date":145,"type":54},"2024-07-29",{"date":147,"type":54},"2020-12-01",{"date":149,"type":21},"2024-12-31",{"name":151,"class":90},"Imperial College Healthcare NHS Trust",2]