Protein-enriched human milk diet for Neonatal Feeding Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neonatal Feeding Disorder+4 MoreProtein-enriched human milk diet - Procedure
Eligibility
1 - 4
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Neonatal Feeding Disorder
  • Premature Birth
  • Breastfeeding
  • Microbial Colonization
  • Growth Delay

Treatment Effectiveness

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: 2 years of corrected age

Year 2
Cognitive outcomes
Week 36
Body fat(BF)-for-age Z-score
Fat mass(FM)-for-age Z-score
Fat-free mass(FFM)-for-age Z-score
Number of participants with postnatal growth failure
Birth to 120 days
Culture-proven sepsis
Death
Day 120
Duration of hospital stay in days
Number of participants with diagnosis of intestinal perforation
Number of participants with diagnosis of necrotizing enterocolitis
Birth to 28 days
Number of days alive and receiving full enteral feeding
Number of episodes of feeding intolerance
Serum creatinine
Week 36
Changes in intestinal microbiome
Week 36
Anthropometric measurements
Growth rate

Trial Safety

Trial Design

2 Treatment Groups

Usual human milk diet
1 of 2
Protein-enriched human milk diet
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Protein-enriched human milk diet · No Placebo Group · N/A

Protein-enriched human milk diet
Procedure
Experimental Group · 1 Intervention: Protein-enriched human milk diet · Intervention Types: Procedure
Usual human milk diet
Procedure
ActiveComparator Group · 1 Intervention: Usual human milk diet · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years of corrected age

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,249,988 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,435 Previous Clinical Trials
2,229,084 Total Patients Enrolled
Ariel Salas, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
102 Total Patients Enrolled

Eligibility Criteria

Age 1 - 4 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
A fetus that is younger than 28 weeks gestation is considered to be premature.
You are born at less than 96 hours of gestation.