NCT04294368 · Columbia University
Targeted Fortification of Donor Breast Milk in Preterm Infants
What this study is about
This study is a randomly assigned 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.
View original scientific description
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.
Interventions
DIETARY_SUPPLEMENT
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid
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.
DIETARY_SUPPLEMENT
Similac Liquid Protein Fortifier
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.
DIETARY_SUPPLEMENT
Nestle Microlipid
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.
DIETARY_SUPPLEMENT
Medica Nutrition SolCarb
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.
DIETARY_SUPPLEMENT
Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)
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.
DIETARY_SUPPLEMENT
Similac Liquid Protein Fortifier (Targeted Fortification)
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.
DIETARY_SUPPLEMENT
Nestle Microlipid (Targeted Fortification)
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
DIETARY_SUPPLEMENT
Medica Nutrition SolCarb (Targeted Fortification)
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
OTHER
Analysis with Miris (AB) Human Milk Analyzer
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.
Primary outcome measures
Change in weight
Time frame: Up to 11 weeks
Weight change in g/kg/day, z-score value, and change in z-score from week-to-week
Change in length
Time frame: Up to 11 weeks
Length change in cm/kg/day, z-score value, and change in z-score from week-to-week
Head circumference
Time frame: Up to 11 weeks
Head circumference change in cm/kg/day, z-score value, and change in z-score from week-to-week
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations