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

118 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

While new innovations in the care of extremely premature infants have led to decreased morbidity and mortality, poor postnatal growth remains as a major challenge. Early growth in the postnatal period influences neurodevelopmental and growth outcomes. This proposed study will challenge current nutritional regimens for infants \< 1000 g birth weight (BW) by providing an exclusive human milk based diet with a higher amount of protein based on individual caloric and protein analysis of human milk utilizing targeted fortification. The investigators will evaluate the effects of a high versus standard protein enteral diet on growth and body composition in infants \< 1000 g BW. There are no published studies evaluating the effect of an exclusive human milk protein diet on body composition in premature infants. 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 diet is well tolerated and associated with improved outcomes in the highest risk neonates, it is imperative to evaluate the benefits of a high protein exclusive human milk diet and the possible positive changes in body composition, specifically lean mass, in these infants. Results from this proposed study will immediately influence current nutritional practices and will provide landmark information regarding targeted fortification with provision of adequate protein providing the most optimal body composition in the most fragile and 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.

Is a high protein diet safe for premature infants?

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-up in the blood), and high amino acid levels. However, other studies indicate that protein intake between 3.5 and 4.0 g/kg/day can promote weight gain and development without clear evidence of harm, but more research is needed to confirm safety. ^{1 2 3 4 5}

How does the high protein diet treatment for premature infants differ from other treatments?

The high protein diet for premature infants is unique because it aims to meet the exceptionally high protein needs of these infants, which are often unmet by standard formulas or breast milk fortifiers. Unlike traditional approaches that limit protein due to past concerns about safety, this treatment emphasizes higher protein intake to support growth and neurodevelopment, addressing a critical gap in current nutritional practices for preterm infants. ^{2 3 5 6 7}

What data supports the effectiveness of the high protein diet treatment for premature infants?

Research shows that a high protein intake of 3.5 to 4.0 grams per kilogram per day can help very-low-birth-weight preterm infants gain weight and improve development. This suggests that a high protein diet may be beneficial for premature infants. ^{3 4 8 9 10}

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

Effect of Enteral Protein Amount on Growth and Health Outcomes in Very-Low-Birth-Weight Preterm Infants: Phase II of the Pre-B Project and an Evidence Analysis Center Systematic Review. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Effect of high-energy and/or high-protein feeding in children with congenital heart disease after cardiac surgery: a systematic review and meta-analysis. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Optimal protein and energy intakes in preterm infants. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Calorie and protein-enriched formula versus standard term formula for improving growth and development in preterm or low birth weight infants following hospital discharge. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of early enteral feeding in children less than 3 years old with smaller burns (8-25 per cent TBSA). [2019]

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

Does amount of protein in formula matter for low-birthweight infants? A Cochrane systematic review. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Protein Needs of Preterm Infants: Why Are They So Difficult to Meet? [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Hydrolyzed Proteins in Preterm Infants. [2018]

9. Indonesia pubmed.ncbi.nlm.nih.gov

New perspectives in the nutrition of premature and low birth weight infants. [2008]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Amount and quality of dietary proteins during the first two years of life in relation to NCD risk in adulthood. [2012]