Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Not Applicable

Active, not recruiting

• Conditions: Breast Milk Expression; Microbial Colonization; Prematurity; Extreme; Feeding Disorder Neonatal; Growth Failure
• Interventions: Procedure: Usual human milk diet; Procedure: Protein-enriched human milk diet

• Registration Number: NCT04325308
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.

Detailed Description

Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-27
• Study Start: 2020-08-13
• Primary Completion: 2023-01-02
• Results First Submitted: 2023-12-30
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Results First Posted: 2024-03-13
• Last Update Posted: 2024-03-13
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Gestational age ≤ 28 weeks of gestation
• Postnatal age < 96 hours

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Exclusion Criteria

• Congenital malformations
• Chromosomal anomalies
• Terminal illness needing to limit or withhold support

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual human milk diet	Usual human milk diet	Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.
Protein-enriched human milk diet	Protein-enriched human milk diet	Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Primary Outcome Measures

Name	Time	Method
Fat-free Mass(FFM)-For-age Z-score	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer	Estimated by air displacement plethysmography. FFM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.

Secondary Outcome Measures

Name	Time	Method
Body Fat(BF)-For-age Z-score	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer	Body fat estimated by air displacement plethysmography. BF measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.
Number of Participants With Diagnosis of Necrotizing Enterocolitis	From birth up to 120 days following birth	Diagnosis of necrotizing enterocolitis stage 2 or 3
Number of Days Alive and Receiving Full Enteral Feeding	Birth to 28 days	Time to full enteral feeding days
Serum BUN	Birth to 28 days	Highest serum BUN value in the first 28 days after birth
Number of Episodes of Feeding Intolerance	Birth to 28 days	Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
Duration of Hospital Stay in Days	Birth to 120 days or discharge, whichever occurs first	From day of admission to day of hospital discharge to home
Anthropometric Measurements	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)	Weight, length, and head circumference measurements. Measurements were converted into Z-scores based on Fenton growth curves (2013). They were calculated at birth and at 36 weeks. This outcome represents the change in weight, length, and head circumference Z-score during the course of the study (i.e., the Z-score at birth was subtracted from the Z-score at 36 weeks).; A value of 0 represents that the infant's Z-score is the same at the beginning and the end of the study. Positive values indicate the increase in the infant's Z-score during the study; negative values indicate the decrease in the infant's Z-score during the study.
Growth Rate	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)	Weight gain in g/kg/day
Number of Participants With Postnatal Growth Failure	36 weeks or hospital discharge (whichever occurred first)	Diagnosis of growth failure (weight \< 10th percentile using the 2013 Fenton growth curves)
Number of Participants With Diagnosis of Intestinal Perforation	From birth up to 120 days following birth	Diagnosis of intestinal perforation
Fat Mass(FM)-For-age Z-score	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer	Estimated by air displacement plethysmography. FM measurements were converted into Z-scores using updated, sex-specific reference curves of body composition in preterm infants (Norris et al, 2019). A Z-score of 0 represents the population mean. Z-score values closer to 0 represent a better outcome. No relevant thresholds have been defined.
Death	Birth to 120 days	Death prior to 121 days of life
Culture-proven Sepsis	Birth to 120 days	Diagnosis of sepsis with positive blood cultures

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States