High Protein Diet for Premature Infants

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Major congenital anomalies, congenital heart disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: Until 35-36 weeks postmenstrual age

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-protein diet derived from human milk can improve growth and body composition in extremely premature infants weighing less than 1000 grams at birth. The goal is to determine if this diet enhances development compared to a standard protein diet, particularly in terms of lean body mass. Infants born very small, who have begun feeding by two weeks old, and are receiving exclusive human milk-based nutrition qualify as candidates for this trial. The findings could revolutionize nutrition management for some of the smallest and most fragile newborns. As an unphased trial, participation offers a unique opportunity to contribute to groundbreaking research that could transform nutritional care for vulnerable infants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that this high protein diet is safe for premature infants?

Research has shown that high-protein diets are generally safe for premature infants, but some considerations remain. Studies have found that protein intake up to 4.5 grams per kilogram per day is safe for infants weighing more than 1000 grams. However, less information exists about infants weighing less than 1000 grams, which is the focus of this trial.

Some studies suggest that very high protein levels might cause issues like acidosis (excess acid in the body) or uremia (waste buildup in the blood) in premature infants. These effects are rare but important to monitor.

Overall, while high-protein diets can support growth in preterm infants, careful monitoring of protein intake is crucial to avoid potential problems. This trial aims to find the right balance to help the smallest and most vulnerable babies grow well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring a high protein diet for premature infants because it could lead to better growth outcomes compared to the standard protein diet. Unlike traditional feeding regimens that provide 3.5 to 3.8 grams of protein per kilogram per day, this high protein approach aims for 4.2 to 4.5 grams, potentially enhancing muscle and bone development. The goal is to optimize the nutrition of these vulnerable infants, potentially leading to healthier growth trajectories and improved overall development.

What evidence suggests that a high protein diet is effective for improving growth and body composition in premature infants?

This trial will compare a high-protein diet with a standard protein diet for premature infants. Research has shown that a high-protein diet can improve growth in premature infants. Studies have found that babies receiving more protein tend to grow closer to expected standards. This diet is believed to aid in muscle development, benefiting overall growth. However, some research mentions possible side effects, such as excess acid in the body or waste buildup in the blood. Despite these concerns, the diet is generally considered safe and effective for babies weighing over 1000 grams. The goal is to find the right balance to promote growth without causing harm. ^{1 2 3 4 6}

Who Is on the Research Team?

Amy B Hair, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for extremely premature infants weighing between 500-1000 grams at birth, who are expected to survive until at least 36 weeks postmenstrual age. They must be able to start feeding within the first two weeks of life and can either be born at or transferred to the study institution within their first day of life.

Inclusion Criteria

I was able to eat food through my mouth or a tube within 14 days after birth.

Reasonable expectation of survival for study duration (36 weeks postmenstrual age)

Born at our institution or transferred from another institution within the first 24 hours of life and receive an exclusive human milk protein diet (mother's milk supplemented with donor human milk and donor human milk derived fortifier)

Exclusion Criteria

Unable to participate in the study for any reason based on decision of study investigator

I do not have major birth defects, serious heart issues, or severe intestinal problems before I could eat solid food.

I was unable to eat by mouth within my first 14 days of life.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive either a high protein or standard protein enteral diet based on randomization

Until 35-36 weeks postmenstrual age

Weekly anthropometric measurements

DXA Scan and Lab Assessments

DXA scan performed to evaluate body composition; labs for serum blood urea nitrogen, creatinine, calcium, phosphorus, and alkaline phosphatase

1 week

1 visit for DXA scan and lab assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Protein Diet
• Standard Protein Diet

Trial Overview The study compares growth and body composition outcomes in preterm infants given a high protein human milk diet versus those on a standard protein human milk diet. It aims to determine if higher protein improves overall body composition, particularly lean mass.

How Is the Trial Designed?

Group I: Intervention Group (High Protein Diet) Experimental Treatment 1 Intervention

The intervention group will receive the same standard feeding regimen with the addition of extra milk fortification to give a high protein diet. Human milk will be prepared and analyzed in the same method as the control group. Based on the amount of protein in the milk, fortification of feeds with donor milk derived fortifier will be adjusted to reach an average of 4.2 to 4.5 g/kg/day. The diet will be continued until approximately 35 to 36 weeks PMA at which point a DXA scan will be performed. Infants will have 3 sets of labs. A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed. Anthropometrics: weekly weight, length, and head circumference by trained research nurse.

Group II: Control Group (Standard Protein Diet) Active Control 1 Intervention

Infants will receive a standard feeding regimen which consists of mother's own milk or donor human milk (DHM) with DHM derived fortifier. Once daily, a 24 hour batch of human milk is prepared for each infant (standard practice). A 2.5 mL sample will be analyzed for calories, protein, fat, and carbohydrates. Based on the amount of protein in the milk, fortification of feeds with donor human milk derived fortifier will be adjusted to reach an average of 3.5 to 3.8 g/kg/day of protein. Data will be recorded for milk analysis, nutrition, and infant growth. The diet will be continued until approximately 35 to 36 weeks postmenstrual age at which point a DXA scan will be performed. A serum blood urea nitrogen and creatinine as well as serum calcium, phosphorus, and alkaline phosphatase when the DXA is performed. Anthropometrics: weekly weight, length, and head circumference by trained research nurse.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Citations

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

High protein intake on later outcomes in preterm children We found that infants in the high protein group had a higher risk of developing refeeding syndrome and its biochemical components, ...

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

Protein Intake and Growth in Preterm Infants Additionally, intakes as high as 4.5 g/kg/day were shown to be safe in infants weighing >1000 g.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02943746

Targeted Protein Fortification in Extremely Low Birth ... Hypothesis 2: Infants who received a high protein diet will have greater fat-free mass (lean mass) compared to infants who received a standard protein diet. ...

4. withpower.com withpower.com/trial/phase-birth-weight-10-2016-b447e

High Protein Diet for Premature Infants · Info for Participants Some studies suggest that high protein intake in premature infants may lead to negative effects like acidosis (too much acid in the body), uremia (waste build- ...

5. 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 ...

6. mdpi.com mdpi.com/2227-9067/12/6/759

Controversies in Parenteral Protein Intake in Preterm Infants Moreover, optimal protein intake shortly after birth is closely associated with improved clinical outcomes, including enhanced short-term growth at 36 weeks ...