Protein-Enriched Human Milk for Premature Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether giving extremely preterm infants milk with extra protein helps them grow stronger and develop healthier guts compared to regular milk. Some infants will receive milk with extra protein shortly after birth, while others will receive regular milk. Researchers hope to see better growth and gut health in the babies who get the extra protein. Protein supplementation of human milk has been studied to improve growth and development in preterm infants, but results have been mixed.
Do I need to stop my current medications for the trial?
The trial information does not specify whether participants need to stop taking their current medications.
Is protein-enriched human milk safe for premature infants?
How does the treatment Protein-enriched Human Milk Diet differ from other treatments for premature infants?
The Protein-enriched Human Milk Diet is unique because it specifically increases the protein content of human milk to meet the high nutritional needs of premature infants, which standard human milk fortifiers often fail to do. This treatment uses a combination of amino acids and small peptides to raise protein levels, along with added minerals like calcium and phosphorus, to support optimal growth and development in very-low-birth-weight infants.14678
What data supports the effectiveness of the treatment Protein-enriched Human Milk Diet for premature infants?
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 and are less than 96 hours old. It's not suitable for babies with chromosomal anomalies, significant congenital malformations, or those with a terminal illness where medical support would be limited.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either a protein-enriched human milk diet or a usual human milk diet during the first 2 weeks after birth
Follow-up
Participants are monitored for safety and effectiveness after treatment, including growth and microbiome assessments
What Are the Treatments Tested in This Trial?
Interventions
- Protein-enriched Human Milk Diet
- Usual Human Milk Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator