Protein-Enriched Human Milk for Premature Infants

Overseen By Ariel Salas, MD, MSPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Congenital malformations, Chromosomal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

150 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Protein-enriched Human Milk Diet for premature infants?

Research shows that fortified human milk, which includes added protein, helps premature infants grow faster and improves their nutritional status compared to unfortified milk. This suggests that a protein-enriched human milk diet can be beneficial for premature infants. ^{1 2 3 4 5}

Is protein-enriched human milk safe for premature infants?

Research suggests that protein-enriched human milk is generally safe for premature infants, supporting adequate growth and nutrition. Some studies indicate it may also reduce digestive issues and skin conditions in some infants. ^{1 3 4 6 7}

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. ^{3 4 5 8 9}

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.

Research Team

Ariel A. Salas, MD, MSPH

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

My baby is less than 4 days old.

Gestational age ≤ 28 weeks of gestation

Exclusion Criteria

Congenital malformations

My condition involves chromosomal anomalies.

Terminal illness needing to limit or withhold support

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive either a protein-enriched human milk diet or a usual human milk diet during the first 2 weeks after birth

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including growth and microbiome assessments

36 weeks or until hospital discharge, up to 120 days following birth

Treatment Details

Interventions

• Protein-enriched Human Milk Diet
• Usual Human Milk Diet

Trial Overview The study is testing if feeding extremely preterm infants a protein-enriched human milk diet versus the usual human milk diet can improve their growth without fat gain and help develop their gut bacteria by the time they reach their due date.

Participant Groups

Group I: Protein-enriched human milk diet Experimental Treatment 1 Intervention

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Group II: Usual human milk diet Active Control 1 Intervention

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Fortified human milk significantly supports the growth and nutritional needs of premature infants when fed at approximately 180 mL/kg/day, improving their overall health and development compared to unfortified milk.

Neonatal centers should promote the use of fortified human milk and provide lactation support, as well as encourage skin-to-skin contact to enhance milk production and improve breastfeeding success for premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of human milk and breastfeeding in premature infants. Schanler, RJ., Hurst, NM., Lau, C.[2018]

Targeted fortification of human milk significantly improved growth rates in very low birth weight preterm infants, with weekly weight gain averaging 205.5 g compared to 155 g in those receiving standard fortification.

The study found no gastrointestinal or metabolic intolerance in infants receiving targeted fortification, indicating it is a safe method for enhancing nutrition in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. Morlacchi, L., Mallardi, D., Giannì, ML., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tolerance of Hydrolyzed Liquid Protein Fortified Human Milk and Effect on Growth in Premature Infants. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Growth, biochemical status, and mineral metabolism in very-low-birth-weight infants receiving fortified preterm human milk. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Growth in human milk-Fed very low birth weight infants receiving a new human milk fortifier. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Considerations in meeting protein needs of the human milk-fed preterm infant. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The use of human milk and breastfeeding in premature infants. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Human Milk Supplements: Principles, Practices, and Current Controversies. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Is targeted fortification of human breast milk an optimal nutrition strategy for preterm infants? An interventional study. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Fortification of maternal milk for very low birth weight (VLBW) pre-term neonates. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Feeding of very-low-birth-weight infants with breast-milk enriched by energy, nitrogen and minerals: FM85. [2013]