Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development (NCT03977259) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development
United States130 participantsStarted 2020-01-31
Plain-language summary
This study is a randomized trial comparing 2 methods of human milk fortification for preterm infants in the neonatal intensive care unit (NICU). All participating infants will receive a human milk diet comprising maternal and/or donor milk plus multi-component and modular fortifiers. In one group (control), the milk will be fortified according to routine standard of care. In the other group (intervention), the fortification will be individually targeted based on the results of point-of-care human milk analysis. Outcomes include physical growth in the NICU and after discharge, brain structure by magnetic resonance imaging at term equivalent age, and neurodevelopment at 2 years.
Who can participate
Age range
1 Day – 21 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inpatient in Brigham and Women's Hospital NICU
* Gestational age 24 0/7 to 30 6/7 weeks
* Chronologic age \<21 days
* Mother providing breast milk
Exclusion Criteria:
* Major congenital anomaly
* Severe fetal growth restriction (birth weight \<3rd percentile by Olsen reference)
* Necrotizing enterocolitis, intestinal perforation, other major gastrointestinal pathology
* Triplets or higher order multiples
* Plan for redirection of care and/or anticipated death
* Clinically significant renal or hepatic dysfunction
* Inborn error of metabolism
* Fluid restriction \<140 mL/kg/day for 3 or more days
* Grade 3 or 4 intraventricular hemorrhage detected prior to enrollment
* Anticipated transfer \<36 weeks' postmenstrual age
* Parents do not consent to use of pasteurized donor human milk
* Infant in non-parental custody
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Weight
Timeframe: at study endpoint (36 weeks' postmenstrual age or discharge)
2
Length
Timeframe: at study endpoint (36 weeks' postmenstrual age or discharge)
3
Fat free mass
Timeframe: at study endpoint (36 weeks' postmenstrual age or discharge)
4
Total brain volume
Timeframe: at term equivalent age (38 to 41 weeks' postmenstrual age)
5
Cerebellar volume
Timeframe: at term equivalent age (38 to 41 weeks' postmenstrual age)