Personalized nutrition to support growth and brain development in preterm infants
Official title: Transforming Health and Resilience Via Individualized Nutrition in Very Preterm Infants for Extrauterine Growth and Development
Run by Children's National Research Institute · NCT06266455 · Data updated 2026-11-12
This study is testing whether a personalized nutrition plan for very preterm infants can help them grow better and develop their brains more effectively compared to standard milk fortification.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 4 Weeks |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Children's National Research Institute Academic / other |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | February 8, 2024 |
| Main results expected | January 2034 |
| Study ends | January 2034 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT06266455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at a gestational age of 32 weeks or less who are less than 4 weeks old at the time of enrollment and whose mothers plan to provide human milk.
✕Probably not a fit
Patients who are formula-fed prior to 36 weeks postmenstrual age or have significant congenital anomalies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on improving the nutritional support for very preterm infants by comparing standardized fortification of human milk with an individualized approach that adjusts nutrient levels based on each infant's specific needs. The goal is to address the nutritional deficiencies that many preterm infants face, which can lead to poor growth and adverse neurodevelopmental outcomes. By utilizing recent advances in adjustable fortification methods, the study aims to optimize nutrient intake and enhance growth and brain development in these vulnerable infants.
Why it matters
Potential benefit: If successful, this approach could significantly improve growth and neurodevelopmental outcomes for very preterm infants.
How similar studies have gone: While individualized nutrition approaches are gaining attention, this specific method of adjustable fortification for very preterm infants is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Children's National Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Study coordinator: Catherine Limperopoulos, Ph.D.
- Email: CLimpero@childrensnational.org
- Phone: 202-476-5293
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.