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Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

RecruitingNAAges any - 4 WeeksAllChildren's National Research Institute
NCT06266455 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Recent advances allow for individualized methods of

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📋 Eligibility rules (as published)
Inclusion Criteria: * Birth gestational age (GA) of ≤32 weeks * Postnatal age ≤4 weeks at time of enrollment * Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply * Maternal age \> 18 years old Exclusion Criteria: * Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity * Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection * Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment
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What it tests

  • Standardized Fortification
  • Adjustable Fortification
  • Adjustable Fortification
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Where

1 site
Children's National Hospital
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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