Protein Supplementation for Premature Infants

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Necrotizing enterocolitis, Malformations, Terminal illness

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if increased protein intake can reduce body fat in very premature infants by three months of age. Two groups participate: one receives standard protein supplementation, while the other receives high protein supplementation with their milk. The trial seeks infants born between 25 and 28 weeks of pregnancy who can consume at least 120 ml/kg of milk daily by their second week of life. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance nutrition for very premature infants.

Will I have to stop taking my current medications?

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 providing preterm infants with high protein levels can yield mixed safety results. Studies indicate that protein amounts up to 4.5 grams per kilogram per day are generally safe for infants weighing more than 1000 grams, suggesting they can handle high protein levels well. However, concerns exist that excessive protein might impact their metabolism and future development.

Increasing protein and calorie intake has been linked to improved growth and development in preterm infants, often resulting in greater muscle and organ growth, which is crucial. Despite these benefits, some evidence suggests that very low birth weight infants might face a higher risk of developmental issues, although this risk is not directly related to protein intake.

In summary, while high protein supplementation is mostly considered safe, balancing the benefits with potential risks remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for premature infants, which involves standard protein supplementation from mother's milk or donor milk with added fortifiers, the high protein supplementation approach adds a fixed amount of commercially available hydrolyzed bovine protein. This extra protein could potentially support better growth and development in these infants, which is crucial during their early stages of life. Researchers are excited because this method offers a promising way to enhance nutrition and improve health outcomes for premature infants, possibly leading to a stronger start in their development compared to traditional options.

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

This trial will compare high protein supplementation with standard protein supplementation for premature infants. Research has shown mixed results for high protein intake in premature babies. Some studies suggest that formula with more protein may improve weight gain. However, another review found no clear growth benefits from high protein intake and noted potential risks, such as a slight increase in cognitive issues. While protein is important for growth, finding the right balance is crucial to avoid negative effects. ^{1 2 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 between 25 and 28 weeks of gestation who are being fed human milk and can handle feeding volumes of at least 120 ml/kg/day by the second week. Infants with severe intestinal disease (NEC stage 2+), life-limiting conditions, or malformations in the gut or nervous system cannot participate.

Inclusion Criteria

Babies who are getting fed more than 120 ml of milk per kilogram of their body weight each day by the time they are 14 days old.

Gestational age between 25 and 28 weeks of gestation

Exclusion Criteria

My condition is NEC stage 2 or higher.

I have abnormalities in my digestive system or nervous system.

Terminal illness needing to limit or withhold support will be exclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive either standard or high protein supplementation until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first

Up to 7 weeks

Follow-up

Participants are monitored for body composition, growth, and other health metrics

3 months

What Are the Treatments Tested in This Trial?

Interventions

• High protein supplementation
• Standard protein supplementation

Trial Overview The study is testing whether giving very premature babies more protein than usual in their diet will result in less body fat when they reach three months old. Babies will receive either standard or high levels of protein supplementation to see which affects body composition better.

How Is the Trial Designed?

Group I: High protein supplementation Experimental Treatment 1 Intervention

Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Group II: Standard protein supplementation Active Control 1 Intervention

Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Children's Health System, Alabama

Collaborator

Trials

6

Recruited

610+

Citations

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

High protein intake on later outcomes in preterm children In 44 studies that included data from 5338 children, we found no evidence of overall benefit of high protein intake for growth after the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4804669/

Protein Intake and Growth in Preterm Infants The former concluded infants receiving formula with higher protein content had improved weight gain. The review compared “high” (3.0-4.0 g/kg/day) with “low” (< ...

3. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-021-03052-w

Effectiveness of feeding supplementation in preterm infants The aim of this review was to comprehensively describe the effectiveness of feeding supplementation in promoting health outcomes of preterm infants.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38858504/

High protein intake on later outcomes in preterm children High protein intake in preterm children may slightly reduce survival without neurodisability, increase cognitive impairment risk, and may be ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1744165X25000290

Parenteral nutrition for preterm infants: benefits and risks in ... There are no data to show that starting routinely at higher intakes (≥3 g/kg/day) is beneficial [19,20], and most NICUs will start with ∼1–2 g/kg/day of AAs.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613713/

Preterm nutrition and neurodevelopmental outcomes - PMC Increased caloric and protein intakes in preterm infants are associated with a higher fat free mass (a key marker for organ growth) and better neurodevelopment ...

7. publications.aap.org publications.aap.org/pediatrics/article/123/5/1337/71438/First-Week-Protein-and-Energy-Intakes-Are

First-Week Protein and Energy Intakes Are Associated With ... Long-term outcome data indicate that ELBW infants are at increased risk for adverse neurodevelopmental outcomes, which are not accounted for ...