[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"very-low-birth-weight-infant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:very-low-birth-weight-infant":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,73,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100536563","individualized-nutrition-to-optimize-preterm-infant-growth-and-neurodevelopment-100536563",false,"NCT06266455","Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment","Transforming Health and Resilience Via Individualized Nutrition in Very Preterm Infants for Extrauterine Growth and Development","THRIVE","Inclusion Criteria:\n\n* Birth gestational age (GA) of ≤32 weeks\n* Postnatal age ≤4 weeks at time of enrollment\n* Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply\n* Maternal age \\> 18 years old\n\nExclusion Criteria:\n\n* Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity\n* Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection\n* Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment","ALL","4 Weeks",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.\n\nRecent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.\n\nThrough this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.",[27,28],"Very Preterm Maturity of Infant","Very Low Birth Weight Infant",[30,31,32,33],"Magnetic Resonance Imaging","Neurodevelopment","Nutrition","Fortification","RECRUITING","2025-07-08",{"date":37,"type":38},"2025-07-11","ACTUAL",{"date":40,"type":38},"2024-02-08",{"date":42,"type":21},"2034-01",{"name":44,"class":45},"Children's National Research Institute","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":46},"100380893","swiss-neonatal-network--follow-up-group-100380893","NCT04239508","Swiss Neonatal Network & Follow-up Group","SwissNeoNet","Inclusion criteria of \"Minimal Neonatal Dataset\" (MNDS):\n\nAll Swiss live-born infants below 32 weeks gestational age or 1501g birth weight\n\nInclusion criteria of \"Below 34 data collection\", (B34):\n\nAll Swiss live-born infants between 32 0\u002F1 and 33 6\u002F7 weeks gestational age that are above 1500g birth weight\n\nInclusion criteria of \"Swiss Asphyxia and Cooling Registry\", (ASP):\n\nInfants between 35 0\u002F7 and 42 6\u002F7 weeks' gestational age with moderate or severe encephalopathy due to perinatal asphyxia","0 Days","28 Days",{"count":57,"type":21},1000,"6 Years","OBSERVATIONAL","The chief aim of the Swiss Neonatal Network \\& Follow-Up Group (SwissNeoNet) is to maintain and \u002F or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a coordinated program of research, education and collaborative audit. In support of its aim, SwissNeoNet hosts the official medical quality register for the Swiss level III and level IIB units. Participation for these units is mandatory according to the intercantonal declaration for Highly Specialized Medicine (HSM) of September 22, 2011 and the Society's Standards for Levels of Neonatal Care in Switzerland.",[28,27,62],"Asphyxia Neonatorum","2025-06-25",{"date":65,"type":38},"2025-06-29",{"date":67,"type":38},"2000-01-01",{"date":69,"type":21},"2050-12-31",{"name":71,"class":72},"Swiss Neonatal Network","NETWORK",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":46},"100558760","pilot-trial-investigating-every-other-day-dosing-of-oral-iron-in-premature-infants-iqonic-100558760","NCT06555315","Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)","Pilot Non-inferiority Study Investigating Daily Versus Every Other Day Dosing of Oral Iron in Premature Infants.","Inclusion Criteria:\n\n* Children (Minor \\\u003C 18 years of age)\n* Neonates\n* Hospitalized\n* Premature infants who are on full enteral feeds and are started on oral iron\n* Premature infants who completed 26 0\u002F7 to 32 6\u002F7 weeks' gestation at birth\n\nExclusion Criteria:\n\n• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization",true,"26 Weeks","32 Weeks",{"count":84,"type":21},100,[24],"Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates",[28,88,89,90,91],"Premature Infants","Anemia of Prematurity","Iron Deficiency, Anaemia in Children","Extremely Low Birth Weight",[93,94,95,96],"Premature infants","Iron","anemia of prematurity","iron deficiency","2024-08-13",{"date":99,"type":38},"2024-08-15",{"date":101,"type":38},"2024-08-01",{"date":103,"type":21},"2026-03-28",{"name":105,"class":45},"CHRISTUS Health",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":80,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100549412","phase-3-enteral-zinc-supplementation-in-very-low-birth-weight-infants-100549412","NCT06433674","Enteral Zinc Supplementation in Very Low Birth Weight Infants","Inclusion Criteria:\n\n1. Birth weight \\\u003C 1500 grams\n2. Infant is tolerating at least 100 ml\u002Fkg\u002Fday of enteral feeds\n3. At least 25wks PMA.\n\nExclusion Criteria:\n\n* Major congenital malformations especially anomaly of the GI tract\n* Major congenital heart disease (i.e.: ductal dependent lesion)\n* Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection\n* Infant who has tolerated ≥100 ml\u002Fkg\u002Fday prior to admission.","25 Weeks","36 Weeks",{"count":115,"type":21},50,[117],"PHASE3","The goal of this clinical trial is to observe for changes in rate of weight gain in the very low birth weight (VLBW) infants by adding an enteral Zinc supplement of 1 mg\u002Fkg\u002Fday of elemental zinc. The main question it aims to answer:\n\n• Does an enteral Zinc supplement of 1 mg\u002Fkg\u002Fday increase rate of weight gain in VLBW infants Researches will compare the experimental group to a placebo group to see if there is a statistical difference in rate of weight gain between the two groups\n\n* Once the participants have reached 100 ml\u002Fkg\u002Fday of enteral feeds. The participants will be randomized to one of two groups. The treatment group will receive \\~1 mg\u002Fkg\u002Fday of elemental enteral Zinc, and the control group to receive similar amount of enteral sterile water put in a colored syringe. The Zinc Supplement would be Zinc Sulfate. The primary team would otherwise be managing the patient's feeding using our hospital's feeding protocol. As long as the patient is tolerating 100 ml\u002Fkg\u002Fday of enteral feeds, the Zinc Supplement will continue until 36 weeks postmenstrual age (PMA) or hospital discharge, whichever comes first.\n* The participants will have three Zinc levels measured: once prior to Zinc Supplementation, once at around the four week mark, and once at the completion of therapy.",[28,120],"Nutritional Deficiency","NOT_YET_RECRUITING","2024-06-04",{"date":124,"type":38},"2024-06-06",{"date":126,"type":21},"2024-06-01",{"date":128,"type":21},"2025-07-01",{"name":130,"class":45},"University of Tennessee"]