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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

Summary

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 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. Through 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.

Conditions

• Very Preterm Maturity of Infant
• Very Low Birth Weight Infant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standardized Fortification	Fortification with liquid, bovine-based HMF to assumed human milk content of 24kcal/oz
DIETARY_SUPPLEMENT	Adjustable Fortification	Additional liquid protein supplementation to maintain serum BUN levels within goal range (9-14mmol/dL)
DIETARY_SUPPLEMENT	Adjustable Fortification	Additional liquid protein and/or MCT oil supplementation to maintain protein, fat, and energy intake within goal range based upon mid-infrared human milk analysis

Timeline

• Start date: 2024-02-08
• Primary completion: 2034-01-01
• Completion: 2034-01-01
• First posted: 2024-02-20
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States