Targeted fortification of donor breast milk for preterm infants
Targeted Fortification of Donor Breast Milk in Preterm Infants
This study is testing if customizing the nutrients in donor breast milk helps preterm infants grow better than using regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Day to 21 Days |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04294368 on ClinicalTrials.gov |
What this trial studies
This study compares standard fortification of donor breast milk to targeted fortification in preterm infants. The goal is to determine if targeted fortification, which measures the nutritional content of donor milk before adding fortifiers, leads to better growth outcomes compared to standard methods. By utilizing advanced technology to analyze the milk's fat, protein, and carbohydrate levels, the study aims to customize the nutritional support provided to these vulnerable infants. The hypothesis is that infants receiving targeted fortification will show improved growth metrics.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born at or before 30 weeks gestational age with a birth weight of 1500 grams or less.
Not a fit: Patients who may not benefit include those with significant congenital anomalies or other serious health conditions that could confound growth outcomes.
Why it matters
Potential benefit: If successful, this approach could enhance growth and nutritional outcomes for preterm infants relying on donor breast milk.
How similar studies have performed: While the approach of targeted fortification is innovative, similar studies have shown promise in improving nutritional outcomes in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature infants born \</= 30 weeks gestational age * Birth Weight \</= 1500 grams Exclusion Criteria: * Parents do no consent to donor milk * Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies * Grade III or IV intraventricular hemorrhage diagnoses prior to randomization * Small for gestational age (\<3% on Fenton Growth Curve) * Failure to initiate fortified feeds prior to 3 weeks of life * Diagnosis of necrotizing entercolitis prior to randomization * Diagnosis of early onset sepsis confirmed with positive culture
Where this trial is running
New York, New York
- Columbia University Medical Center/ New York - Presbyterian — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Marianne Garland, MD — Columbia University
- Study coordinator: Marianne Garland, MD
- Email: mg71@cumc.columbia.edu
- Phone: 212 305 0952
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.