Improving growth and brain development in preterm infants through targeted milk fortification
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
This study is testing if specially tailored milk fortification can help preterm infants in the NICU grow better and develop their brains more effectively compared to standard fortification.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 1 Day to 21 Days |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03977259 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two methods of fortifying human milk for preterm infants in the neonatal intensive care unit (NICU). Infants will receive either standard fortification or an individually targeted fortification based on human milk analysis. The study aims to evaluate the effects of these fortification methods on physical growth, brain structure, and neurodevelopmental outcomes. Participants will be monitored until 36 weeks' postmenstrual age or hospital discharge, whichever comes first.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born before 31 weeks' gestation who are receiving breast milk in the NICU.
Not a fit: Patients with major congenital anomalies, severe growth restrictions, or significant gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance growth and brain development in preterm infants, potentially leading to better long-term health outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing nutrition for preterm infants, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inpatient in Brigham and Women's Hospital NICU * Gestational age 24 0/7 to 30 6/7 weeks * Chronologic age \<21 days * Mother providing breast milk Exclusion Criteria: * Major congenital anomaly * Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference) * Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology * Triplets or higher order multiples * Plan for redirection of care and/or anticipated death * Clinically significant renal or hepatic dysfunction * Inborn error of metabolism * Fluid restriction \<140 mL/kg/day for 3 or more days * Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment * Anticipated transfer \<36 weeks' postmenstrual age * Parents do not consent to use of pasteurized donor human milk * Infant in non-parental custody
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Mandy B Belfort, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Kaitlin Drouin, MA
- Email: kdrouin@bwh.harvard.edu
- Phone: 617-732-8546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.