[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"growth-retardation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:growth-retardation":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100385104","targeted-fortification-of-donor-breast-milk-in-preterm-infants-100385104",false,"NCT04294368","Targeted Fortification of Donor Breast Milk in Preterm Infants","Inclusion Criteria:\n\n* Premature infants born \\\u003C\u002F= 30 weeks gestational age\n* Birth Weight \\\u003C\u002F= 1500 grams\n\nExclusion Criteria:\n\n* Parents do no consent to donor milk\n* Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies\n* Grade III or IV intraventricular hemorrhage diagnoses prior to randomization\n* Small for gestational age (\\\u003C3% on Fenton Growth Curve)\n* Failure to initiate fortified feeds prior to 3 weeks of life\n* Diagnosis of necrotizing entercolitis prior to randomization\n* Diagnosis of early onset sepsis confirmed with positive culture","ALL","1 Day","21 Days",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.",[26,27,28,29,30],"Prematurity; Extreme","Failure to Thrive in Newborn","Growth Retardation","Growth Failure","Infant Nutrition Disorders",[32,33,34,35,36],"Human Milk Analyzer","Miris","Target Fortification","Targeted Fortification","Donor Breast Milk","RECRUITING","2026-04-01",{"date":40,"type":41},"2026-04-07","ACTUAL",{"date":43,"type":41},"2020-03-09",{"date":45,"type":20},"2027-03",{"name":47,"class":48},"Columbia University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100479069","phase-1-melpida-recombinant-adeno-associated-virus-serotype-9-encoding-a-codon-optimized-human-ap4m1-transgene-hap4m1opt-100479069","NCT05518188","Melpida: Recombinant Adeno-associated Virus (serotype 9) Encoding a Codon Optimized Human AP4M1 Transgene (hAP4M1opt)","A Phase 1\u002F2 Open-label Intrathecal Administration of MELPIDA to Determine Its Safety and Efficacy for Patients with Spastic Paraplegia Type 50 (SPG50) Caused by Mutation in the AP4M1 Gene.","Inclusion Criteria:\n\n1. Age 4 months-10 years old\n2. Confirmed diagnosis of SPG50 disease by:\n\n   1. Genomic DNA mutation analysis demonstrating homozygous or compound heterozygous, confirmed pathogenic variants in the AP4M1 gene\n   2. Clinical history or examination features consistent with SPG50 and that include neurologic dysfunction\n3. Parent\u002Flegal guardian willing to provide written informed consent for their child prior to participation in the study\n4. Subject able to comply with all protocol requirements and procedures\n5. Ability to stand for more than 5 seconds OR\n6. Ability to take 5 steps independently or with a walker OR\n7. Modified Ashworth Scale score 2 or below (Ankles).\n\nExclusion Criteria:\n\n1. Inability to participate in study procedures (as determined by the site investigator)\n2. Presence of a concomitant medical condition that precludes lumbar puncture (LP) or use of anesthetics\n3. History of bleeding disorder or any other medical condition or circumstance in which lumbar puncture is contraindicated according to local institutional policy\n4. Inability to be safely sedated in the opinion of the clinical anesthesiologist\n5. Active infection, at the time of dosing, based on clinical observations\n6. Concomitant illness or requirement for chronic drug treatment that in the opinion of the PI creates unnecessary risks for gene transfer\n7. Inability of the patient to undergo MRI according to local institutional policy\n8. Inability of the patient to undergo any other procedure required in this study\n9. The presence of significant non-SPG50 related CNS impairment or behavioral disturbances that would confound the scientific rigor or interpretation of results of the study\n10. Have received an investigational drug within 30 days prior to screening or plan to receive an investigational drug (other than gene therapy) during the study.\n11. Enrollment and participation in another interventional clinical trial\n12. Contraindication to MELPIDA or any of its ingredients\n13. Contraindication to any of the immune suppression medications used in this study\n14. Clinically significant abnormal laboratory values (GGT, ALT, and AST, or total bilirubin \\> 3 × ULN, creatinine ≥ 1.5 mg\u002FdL, hemoglobin \\[Hgb\\] \\< 6 or \\> 20 g\u002FdL; white blood cell \\[WBC\\] \\> 20,000 per cmm) prior to gene replacement therapy.","4 Months","10 Years",{"count":60,"type":20},4,[62,63],"PHASE1","PHASE2","MELPIDA is proposed for the treatment of subjects with SPG50 and targets neuronal cells to deliver a fully functional human AP4M1 cDNA copy via intrathecal injection to counter the associated neuronal loss. Outcomes will evaluate the safety and tolerability of a single dose of MELPIDA, which will be measured by the treatment-associated adverse events (AEs) and serious adverse events (SAEs). Secondarily, the trial will explore efficacy in terms of disease burden assessments.",[66,67,68,28,69,70],"Spasticity, Muscle","Microcephaly","Intellectual Deficiency","SPG50","Spastic Paraplegia","2024-10-04",{"date":73,"type":41},"2024-10-08",{"date":75,"type":41},"2023-02-15",{"date":77,"type":20},"2030-10-01",{"name":79,"class":80},"Elpida Therapeutics SPC","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":49},"100521577","the-effects-of-time-points-to-cease-parenteral-nutrition-and-igf-1-on-very-low-birth-weight-infants-100521577","NCT06071403","The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants","The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study","Inclusion Criteria:\n\n1. Infants with a birth weight less than 1500 grams\n2. Infants admitted within 72 hours after birth\n3. Infants born from July 1, 2023, to June 30, 2024\n4. Written informed consent from parents or guardians\n\nExclusion Criteria:\n\n1. Infants with congenital abnormality\n2. Infants surviving \\\u003C7 days after birth",true,{"count":90,"type":20},416,"OBSERVATIONAL","This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.",[28],"2023-10-04",{"date":96,"type":41},"2023-10-06",{"date":98,"type":41},"2023-07-01",{"date":100,"type":20},"2026-09-30",{"name":102,"class":48},"Peking University"]