This study is a randomized controlled trial comparing standard fortification of donor breast milk to targeted fortification of donor breast milk in preterm infants. The purpose of the study is to determine if there is a benefit to target fortifying donor breast milk in the preterm population. The investigators hypothesize that infants receiving targeted fortification of donor breast milk will have improved growth compared to infants receiving standard fortification of donor breast milk.
Premature infants born </= 30 weeks gestational age
Birth Weight </= 1500 grams
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)
Parallel
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
Dietary supplementThe control group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF.
Similac Liquid Protein Fortifier
Dietary supplementFor participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Nestle Microlipid
Dietary supplementFor participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
Medica Nutrition SolCarb
Dietary supplementFor participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU.
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
Dietary supplementThe experimental group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF. For participants in the experimental group, the investigators will continue to add fortification. Two packets of HMF per day will be added until goal fortification is reached.
Similac Liquid Protein Fortifier (Targeted Fortification)
Dietary supplementParticipants in the experimental group will receive a dose that will vary depending on the base protein content in the donor breast milk for each particular batch of donor breast milk.
Nestle Microlipid (Targeted Fortification)
Dietary supplementParticipants in the experimental group will receive a dose that will vary depending on the base fat content in the donor breast milk for each particular batch of donor breast milk
Medica Nutrition SolCarb (Targeted Fortification)
Dietary supplementParticipants in the experimental group will receive a dose that will vary depending on the base carbohydrate content in the donor breast milk for each particular batch of donor breast milk
Analysis with Miris (AB) Human Milk Analyzer
Other interventionFor participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.
Change in weight
Weight change in g/kg/day, z-score value, and change in z-score from week-to-week
Change in length
Length change in cm/kg/day, z-score value, and change in z-score from week-to-week
Head circumference
Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week
Total Number of Days of Length of Stay in NICU
Today number of days in the NICU.
Rate of Mortality
Rate of morality during NICU hospitalization.
Number of Feeding Intolerance Events
The number of feeding intolerance events, defined as 1 or more feeds held.
Number of Necrotizing Enterocolitis Events
Number of necrotizing enterocolotis events.
Click on the lead sponsor to view all of their trials.
