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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding extra protein to human milk helps extremely premature babies grow better and improve gut health. It compares two groups: one receives a protein-enriched human milk diet, while the other receives a usual human milk diet. Babies born at or before 28 weeks and less than four days old might qualify for this trial. By studying the impact of protein-enriched diets, researchers aim to find ways to support the health and development of premature infants. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the care of premature infants.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding extra protein to breast milk for premature babies can aid short-term growth. However, concerns exist. One study suggested that excessive protein might harm survival, brain development, and metabolism. On the positive side, other studies have found benefits; for example, more protein was linked to improved hearing and language skills at 12 and 18 months. Additionally, starting nutrient supplementation early helped babies grow faster and might reduce serious health risks in very premature infants.

Overall, current research indicates both advantages and disadvantages to adding extra protein to breast milk. While potential risks exist, there are also promising benefits. It is important to discuss with healthcare providers what is best for each baby's needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the usual human milk diet for premature infants, which provides either expressed human milk or donor milk, the protein-enriched human milk diet introduces additional proteins to support the infants' growth and development. This approach is particularly exciting because it aims to address the higher protein needs of premature infants, potentially leading to better growth outcomes and overall health. Researchers are intrigued by the possibility that this enriched diet could offer a more tailored nutritional strategy, optimizing early development during a critical growth period.

What evidence suggests that this trial's treatments could be effective for premature infants?

Research has shown that adding extra protein to human milk can help premature babies grow better. In this trial, one group of infants will receive a protein-enriched human milk diet, while another group will receive the usual human milk diet. Studies have found that very early preterm babies who receive fortified milk often grow longer. Some research also suggests these babies might develop better hearing and language skills as they age. While high protein intake aids early growth, researchers are still studying the long-term effects. Overall, adding protein to human milk appears to be a promising way to support the healthy development of premature infants. ^{2 3 4 6 7}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11634171/

Formula protein versus human milk protein and the effects ... High protein intake supports initial growth in preterm infants, although the long-term benefits remain unclear. Human milk requires adequate fortification to ...

2. nature.com nature.com/articles/s41390-024-03296-z

High protein intake on later outcomes in preterm children Long-term growth and neurodevelopment of extremely preterm infants randomized to fortified human milk diets enriched with a protein supplement.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1744165X25000289

Human milk for preterm infants Infants receiving the higher intake had better hearing and language scores at 12 and 18 months. The other randomised infants <1500 g–4.2 g/kg per day or 3.6 g/ ...

4. publications.aap.org publications.aap.org/pediatrics/article/152/3/e2023061603/193280/Early-Human-Milk-Fortification-in-Infants-Born

Early Human Milk Fortification in Infants Born Extremely ... This trial indicates that early human milk fortification increases length gain velocity and reduces declines in head circumference z scores from birth to term ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02943746

Targeted Protein Fortification in Extremely Low Birth ... Research has shown that infants who receive this diet achieve growth at targeted standards but body composition has not been evaluated. As an all human milk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6513468/

Protein supplementation of human milk for promoting growth ... Adding extra protein to human milk for preterm infants may increase short‐term growth. However, its effect on length of hospital stay, feeding intolerance, and ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00552-7/fulltext

Effect of human milk-based fortification in extremely ... Mortality and severe morbidity remain high in extremely preterm infants. Human milk-based nutrient fortifiers may prevent serious complications and death. We ...