Protein Supplementation for Premature Infants
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive either standard or high protein supplementation until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first
Follow-up
Participants are monitored for body composition, growth, and other health metrics
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Children's Health System, Alabama
Collaborator
Citations
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 ...
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” (< ...
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.
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 ...
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.
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-AreFirst-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 ...
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