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Protein Supplement
High Protein Diet for Premature Infants
N/A
Waitlist Available
Led By Amy B Hair, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Achieve any enteral feedings by 14 days of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed at 35-36 weeks postmenstrual age
Awards & highlights
Study Summary
This trial will study the effects of a high protein diet on premature infants.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this trial involves nutritional interventions with human milk-based diets, side effects are not detailed but may include typical feeding intolerance seen in premature infants such as digestive discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was able to eat food through my mouth or a tube within 14 days after birth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly until 35-36 postmenstrual age (pma)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly until 35-36 postmenstrual age (pma)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Linear growth measured using an premature infant length board
Secondary outcome measures
Body composition measured by dual energy x-ray absorptiometry
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group (High Protein Diet)Experimental Treatment1 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 Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Protein Diet
2017
N/A
~200
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,001,901 Total Patients Enrolled
Amy B Hair, MDPrincipal InvestigatorBaylor College of Medicine
5 Previous Clinical Trials
486 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was able to eat food through my mouth or a tube within 14 days after birth.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.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group (High Protein Diet)
- Group 2: Control Group (Standard Protein Diet)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications for this trial still being accepted?
"This trial, whose initial posting was on November 1st 2016, is not currently seeking participants. Nonetheless, 78 other studies are presently recruiting patients across the world."
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