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Protein Supplement

Protein-Enriched Human Milk for Premature Infants

N/A
Waitlist Available
Led By Ariel Salas, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postnatal age < 96 hours
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years of corrected age
Awards & highlights

Study Summary

This trial is testing whether an enriched human milk diet can help extremely premature babies grow and develop a healthier gut microbiome.

Who is the study for?
This trial is for extremely preterm infants born at or before 28 weeks of gestation and are less than 96 hours old. It's not suitable for babies with chromosomal anomalies, significant congenital malformations, or those with a terminal illness where medical support would be limited.Check my eligibility
What is being tested?
The study is testing if feeding extremely preterm infants a protein-enriched human milk diet versus the usual human milk diet can improve their growth without fat gain and help develop their gut bacteria by the time they reach their due date.See study design
What are the potential side effects?
Since this trial involves dietary changes in very young infants, potential side effects may include digestive issues such as intolerance to the enriched formula, which could affect how well they feed and grow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby is less than 4 days old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years of corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years of corrected age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat-free Mass(FFM)-For-age Z-score
Secondary outcome measures
Anthropometric Measurements
Body Fat(BF)-For-age Z-score
Culture-proven Sepsis
+10 more
Other outcome measures
Changes in Intestinal Microbiome
Cognitive Outcomes

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Protein-enriched human milk dietExperimental Treatment1 Intervention
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
Group II: Usual human milk dietActive Control1 Intervention
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,566 Previous Clinical Trials
2,268,497 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,681 Total Patients Enrolled
Ariel Salas, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
102 Total Patients Enrolled

Media Library

Protein-enriched Human Milk Diet (Protein Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04325308 — N/A
Neonatal Feeding Disorder Research Study Groups: Protein-enriched human milk diet, Usual human milk diet
Neonatal Feeding Disorder Clinical Trial 2023: Protein-enriched Human Milk Diet Highlights & Side Effects. Trial Name: NCT04325308 — N/A
Protein-enriched Human Milk Diet (Protein Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325308 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study open to participants over the age of 55?

"The protocol for this study requires that participants are between 1 and 4 days old."

Answered by AI

How many participants are eligible for enrollment in this experiment?

"Affirmative, clinicaltrials.gov has documented that this trial is actively seeking out volunteers. It was initially posted on August 13th 2020 and recently edited May 20th 2022; it requires 150 participants from a single medical centre."

Answered by AI

Do I possess the requisite criteria to participate in this experiment?

"This clinical trial requires 150 participants with breast expression and who were born within a 4 day window of the gestational age cutoff (≤ 28 weeks) or postnatal period (< 96 hours)."

Answered by AI

Are there any vacancies to join this clinical trial?

"Affirmative. The details provided on clinicaltrials.gov demonstrate that this research endeavor is currently accepting participants. The trial was first posted August 13th 2020, and the most recent update took place May 20th 2022. 150 individuals are needed for enrollment in one clinic site."

Answered by AI
~33 spots leftby Mar 2025