High-energy Human Milk Diets for Premature Birth
(MEND-BPD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a special high-energy human milk diet enriched with DHA/ARA—nutrients vital for brain and eye development—can improve lung function and reduce breathing problems in extremely preterm babies (born at or before 28 weeks). Babies will receive either a regular fortified milk diet or the enriched version for the first 14 days of life. Eligible participants must be born at 28 weeks or earlier and be no older than 72 hours. This study could provide new methods to better support the health of very early preterm infants. As a Phase 1/Phase 2 trial, the research aims to understand how the treatment works and measure its effectiveness in an initial, smaller group of infants, offering a chance to contribute to groundbreaking advancements in neonatal care.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that feeding very preterm infants with their mother's milk leads to better brain development compared to formula. This indicates that human milk is generally safe and may offer developmental benefits.
Previous participants demonstrated that consuming fortified human milk is well-tolerated in similar situations. While some studies have found that human milk alone might lack certain nutrients, adding DHA and ARA (important fatty acids for brain development) helps address this.
Since this trial is in the early stages, it mainly focuses on checking safety and side effects. The researchers are studying the use of fortified human milk with DHA and ARA to ensure it is safe and beneficial for extremely preterm infants.12345Why are researchers excited about this trial's treatment?
Researchers are excited about high-energy human milk diets for premature infants because they offer a tailored nutritional boost that standard fortified human milk diets lack. This approach combines a fortified human milk diet with a DHA/ARA supplement, essential fatty acids that are crucial for brain and eye development. By providing either a low-dose or high-dose of these supplements, the treatment aims to enhance growth and development more effectively within the first critical two weeks of life. This could mean faster and more robust development outcomes for premature infants compared to traditional feeding methods.
What evidence suggests that a high-energy human milk diet could be effective for improving lung function in extremely preterm infants?
Studies have shown that adding extra nutrients to human milk can improve the health of preterm infants. Research indicates that enriching human milk with DHA and ARA, essential fatty acids for brain and eye development, significantly increases these levels in infants. In this trial, the High-energy Group will receive a standard fortified human milk diet plus a DHA/ARA supplement, which has supported healthy growth in very small infants. These findings suggest that such enriched diets could help reduce breathing problems and improve lung function in extremely preterm infants. By boosting the nutritional content of human milk, these diets aim to provide essential support in the early days of life for these vulnerable infants.16789
Who Is on the Research Team?
Ariel A. Salas, MD, MSPH
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for extremely preterm infants born at or before 28 weeks of gestation. It's designed to see if a special high-energy diet right after birth can help their lungs develop better and prevent lung problems.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either a DHA/ARA-enriched, fortified human milk diet or a standard fortified human milk diet for the first 14 days
Follow-up
Participants are monitored for respiratory morbidity and lung function up to 120 days
What Are the Treatments Tested in This Trial?
Interventions
- High-energy Human Milk Diet
Trial Overview
The study compares two groups: one receiving a DHA/ARA-enriched, fortified human milk (high-energy) diet and the other getting standard energy levels in their diet. The goal is to assess the impact on respiratory health within the first two weeks of life.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The control group receives a standard fortified human milk (maternal or donor) diet for the first 14 days.
The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days. Infants in this group will be secondarily assigned to either a low-dose (60/120 mg/kg/day) or high-dose (120/240 mg/kg/day) DHA/ARA supplement.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
High-energy Human Milk Diets in the First Two Weeks After ...
The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days.
2.
ctv.veeva.com
ctv.veeva.com/study/high-energy-human-milk-diets-in-the-first-two-weeks-after-birth-to-reduce-bpd-in-extremely-preterm-iHigh-energy Human Milk Diets in the First Two Weeks After ...
The intervention group receives a standard fortified human milk (maternal or donor) diet plus the DHA/ARA supplement for the first 14 days.
A novel human milk fortifier supports adequate growth in very ...
Use of the novel HMF containing lipids, higher protein and lower carbohydrate levels supports adequate postnatal growth and appears safe and ...
Liquid human milk fortifier significantly improves ...
Human milk fortified with LHMF significantly increased infant PPL DHA and ARA and improved preterm infant DHA and ARA status.
5.
researchgate.net
researchgate.net/publication/261183205_Liquid_human_milk_fortifier_significantly_improves_docosahexaenoic_and_arachidonic_acid_status_in_preterm_infants(PDF) Liquid human milk fortifier significantly improves ...
We report the fatty acid composition of mother's own human milk from one of the largest US cohorts of lactating mothers of preterm infants.
Neurodevelopmental Outcomes of Extremely Preterm ...
Among preterm infants, maternal milk feeding during the birth hospitalization has been associated with better neurodevelopmental outcomes than ...
Outcomes in very preterm infants receiving an exclusive ...
This study compared unfortified pasteurised human donor milk and formula supplements. The principal outcome was survival to 34w postmenstrual age without ...
Donor human milk and structural brain development in very ...
Feeding very preterm infants maternal milk is associated with improved ex-utero third trimester brain development compared to formula, but the ...
Evidence-based nutrition for the very preterm infant in 2024
The conclusion from this study comparing feeding types is that nutritional inadequacies were highest for the infants fed exclusively human milk ...
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