Targeted Fortification of Donor Breast Milk in Preterm Infants

Launched by COLUMBIA UNIVERSITY · Mar 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the best way to strengthen donor breast milk for premature infants. Researchers want to find out if a special method of adding nutrients, called targeted fortification, helps these babies grow better compared to the usual method, known as standard fortification. They believe that infants receiving this targeted approach will gain weight and grow more effectively.

To participate in the trial, infants must be born prematurely, specifically before 30 weeks of pregnancy and weigh 1500 grams or less at birth. Parents who choose to be part of the study will not only help researchers learn more about infant nutrition but will also have their babies receive either the standard or the targeted fortified donor breast milk. It's important to note that families cannot join if their baby has certain health issues or conditions that could affect their growth. If eligible, families can expect to closely monitor their baby’s growth during the study, providing valuable information to improve care for future premature infants.

Gender

ALL

Eligibility 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