An interventional study of Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid and Similac Liquid Protein Fortifier in Prematurity; Extreme, Failure to Thrive in Newborn and Growth Retardation, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 1 Day to 21 Days. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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.
Breast milk is the best food for premature infants due to its ability to protect infants from necrotizing enterocolitis (NEC) and late onset sepsis. When a premature infant's mother's own milk supply is not enough to provide all the milk that her premature infant needs, donated breast milk is the next best option. One of the downsides of donor breast milk is that it often does not contain as much nutrition for the developing infant compared to the milk of a mother of a premature infant. This means a higher likelihood for poor growth in infant receiving mostly donor breast milk compared to mom's own milk. Due to an inability to easily measure the nutritional content of donor breast milk, standard practice has been to assume that the milk has a certain amount of fat, carbohydrates, and protein. Based on these assumptions, a set amount of additional nutritional fortifier is added to both donor and mom's own breast milk prior to it being given to the infant. Studies show that there is often less nutrition in the donor breast milk to start with than assumed. Technology is now available which uses a small volume sample to measure fat, protein, and carbohydrates in human milk, and hence, calculate the calories in the milk. Using this technology, in this study, the investigators will customize the fortification of donor breast milk by first measuring what is in the milk and then adding any additional fortification that is needed to reach the recommended goals for fat, protein, and carbohydrates. The investigators hypothesize that infants receiving this customized milk, so-called "target" fortified donor breast milk, will have better growth than infants receiving the standard amount of fortification added to their donor breast milk.
The study design involves measurement of macronutrient and calorie content of donor breast milk using a point-of-care human milk analyzer (Miris, AB). The individual macronutrient (protein, fat, and carbohydrate) concentrations will be targeted in the intervention group such that the infant will receive protein of 4 g/kg/day, fat of 6.6 g/kg/day, and carbohydrates of 11.6-13.2 g/kg/day. Fortification will be added in a step-wise fashion daily over a 3-4 day period starting when the infant reaches about 80 ml/kg/day in feeding volume. Fortifiers that may be used in this study include: Abbott Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid, Abbott Liquid Protein, Nestle Microlipid, and Medica Nutrition SolCarb. Participants in the control arm will receive donor milk that is fortified in the standard fashion at this institution; that is, 4 packets of Human Milk Fortifier will be added to 100 ml of donor breast milk. Additional fortification such as liquid protein or microlipid may be added to the donor milk and mom's own milk in response to poor growth for participants in both groups, as is standard of care in this Neonatal Intensive Care Unit (NICU). Patients in both experimental and control groups will always receive mom's own milk first when it is available. Mom's own milk will not be analyzed and will always be fortified in the standard fashion for both groups. The participants will be studied until they reach 34 weeks corrected gestational age.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
Standard fortification of breast milk
Dietary Supplement: Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid · Dietary Supplement: Similac Liquid Protein Fortifier · Dietary Supplement: Nestle Microlipid · Dietary Supplement: Medica Nutrition SolCarb · Other: Analysis with Miris (AB) Human Milk Analyzer
Targeted fortification of breast milk
Dietary Supplement: Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification) · Dietary Supplement: Similac Liquid Protein Fortifier (Targeted Fortification) · Dietary Supplement: Nestle Microlipid (Targeted Fortification) · Dietary Supplement: Medica Nutrition SolCarb (Targeted Fortification) · Other: Analysis with Miris (AB) Human Milk Analyzer
The 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.
For 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.
For 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.
For 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 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.
Participants 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.
Participants 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
Participants 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
For 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
Time frame: Up to 11 weeks
Change in length
Length change in cm/kg/day, z-score value, and change in z-score from week-to-week
Time frame: Up to 11 weeks
Head circumference
Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week
Time frame: Up to 11 weeks
Total Number of Days of Length of Stay in NICU
Today number of days in the NICU.
Time frame: Up to 1 year
Rate of Mortality
Rate of morality during NICU hospitalization.
Time frame: Up to one year
Number of Feeding Intolerance Events
The number of feeding intolerance events, defined as 1 or more feeds held.
Time frame: Up to 34 weeks corrected gestational age
Number of Necrotizing Enterocolitis Events
Number of necrotizing enterocolotis events.
Time frame: Up to 1 year of age
Incidence of Bronchopulmonary dysplasia
Incidence of supplemental oxygen requirement at 36 weeks corrected gestational age.
Time frame: Up to 1 year of age
Incidence of Retinopathy of prematurity
Incidence of retinopathy of prematurity
Time frame: Up to 1 year of age
Percentage of Feeds with Donor Milk and Mother's Milk
Percent of feeds that are donor milk and mom's own milk.
Time frame: Up to 34 weeks corrected gestational age
Plan to share: No — Individual participant data (IPD) may be shared with other researchers at Columbia University Medical Center at the end of the study for the purposes of creating a neurodevelopmental follow-up study that involves following participants in the study until they reach 2 years (corrected post-natal age) in neurodevelopment follow-up clinic. Permission for future contact is included in the consent form for participants in this study. Only participants who consent to future contact will be approached about a neurodevelopmental follow-up study.
Started Mar 2020 (actual). Primary completion is estimated for Mar 2027, 84 months after the start.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 84 months is above that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
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