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Antonio","78229",{"type":54,"coordinates":172},[173,174],-98.49363,29.42412,{"lat":174,"lon":173},{"facility":177,"status":29,"city":178,"state":179,"zip":180,"country":52,"cosmosGeoPoint":181,"geoPoint":185,"contacts":29},"WVU Medicine Children's Hospital","Morgantown","West Virginia","26505",{"type":54,"coordinates":182},[183,184],-79.9559,39.62953,{"lat":184,"lon":183},{"type":187,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100481666",false,"NCT05551975","Preterm Infants Fed a Human Milk Fortifier","Growth and Tolerance of Preterm Infants Fed an Experimental Human Milk Fortifier","Inclusion Criteria:\n\n* Birth weight between 700 g-1500 g.\n* ≤ 32 weeks and 0 days GA at birth.\n* Participant has been classified as appropriate for GA (AGA).\n* Enteral feeding of human milk must be initiated by 21 days of life (birth date is day of life 0)\n* Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if fortified with study fortifier and use of mother's own milk (when available) is prioritized.\n* Parent(s) agrees to allow infant to receive both human milk and study HMF.\n* Singleton or twin births only.\n* Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an IRB\u002FIEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.\n\nExclusion Criteria:\n\n* Enteral feeding of preterm infant formula or HMF for \\> 7 days.\n* Expected to be transferred to another facility within 30 days of randomization.\n* Serious congenital abnormalities or underlying disease that may affect growth and development.\n* 5-minute APGAR ≤ 4.\n* Receiving systemic steroids at time of randomization.\n* Receiving probiotics at time of randomization.\n* Grade Ill or IV PVH\u002FIVH.\n* Dependent on invasive ventilation at time of randomization.\n* Maternal incapacity.\n* Mother or infant is currently receiving treatment consistent with HIV therapy.\n* Documentation of maternal use of alcohol or marijuana during pregnancy that in the opinion of the physician is considered abuse.\n* Positive toxicology report for cocaine, opiates, or methamphetamine in mother or infant.\n* Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).\n* Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score \\\u003C3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas \\\u003C 7.0 and seizures and\u002For severe tonic abnormalities in the first 12 hours of life.\n* Confirmed NEC (Bell's Stage II or III).\n* Confirmed current sepsis.\n* Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.\n* Participation in another study that has not been approved as a concomitant study by AN.\n* Participant has an allergy or intolerance to any ingredient in study fortifier.","ALL",{"count":196,"type":197},321,"ESTIMATED","INTERVENTIONAL",[200],"NA","This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).",[203],"Growth","NOT_YET_RECRUITING","2024-06-26",{"date":207,"type":208},"2024-06-28","ACTUAL",{"date":210,"type":197},"2024-09",{"date":212,"type":197},"2028-01",{"name":5,"class":6},14]