Comparing early and selective fortification of human milk for extremely preterm infants
Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
This study is testing whether adding a special fortifier to human milk helps extremely preterm infants grow better and reduces their risk of serious gut problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 0 Days to 6 Days |
| Sex | All |
| Sponsor | Crouse Hospital Academic / other |
| Locations | 1 site (Syracuse, New York) |
| Trial ID | NCT04284280 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of fortifying an exclusive preterm human milk diet with a Human Milk Donor Fortifier on the health outcomes of extremely preterm infants born at or before 27 weeks of gestation. The research focuses on preventing poor growth and necrotizing enterocolitis (NEC), a serious gastrointestinal condition affecting these vulnerable infants. By utilizing a standardized feeding protocol that emphasizes preterm human milk, the study aims to determine the optimal approach to fortification to enhance growth and reduce the incidence of NEC. The study is conducted in a NICU with a long history of successful human milk use and low NEC rates.
Who should consider this trial
Good fit: Ideal candidates for this study are extremely preterm infants with a gestational age of 27 weeks or less who are admitted to the NICU within the first week of life.
Not a fit: Patients with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, or abdominal wall defects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved growth and reduced risk of necrotizing enterocolitis in extremely preterm infants.
How similar studies have performed: Other studies have shown success with similar approaches focusing on human milk and fortification strategies in preterm infants, indicating a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding Exclusion Criteria: * Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect
Where this trial is running
Syracuse, New York
- Crouse Hospital — Syracuse, New York, United States (Recruiting)
Study contacts
- Principal investigator: Bouraa Bou Aram, MD — Crouse Hospital
- Study coordinator: Bouraa Bou Aram, MD
- Email: bouraabouarammd@crouse.org
- Phone: (315)470-7379
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.