Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

N/AActive Not RecruitingNCT04325308

University of Alabama at Birmingham150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

150

Conditions

Prematurity; Extreme Feeding Disorder Neonatal Breast Milk Expression Growth Failure Microbial Colonization

Interventions

Protein-enriched human milk dietPROCEDURE

1.2 g of human-based protein will be added to each 100 ml of human milk administered

Usual human milk dietPROCEDURE

Human-based protein will not be added to the human milk administered.

Eligibility

Sex: ALLMin age: 1 DayMax age: 4 Days

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational age ≤ 28 weeks of gestation * Postnatal age \< 96 hours Exclusion Criteria: * Congenital malformations * Chromosomal anomalies * Terminal illness needing to limit or withhold support

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Fat-free Mass(FFM)-For-age Z-score

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.

Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer

Secondary Outcomes

Fat Mass(FM)-For-age Z-score

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.

Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer

Body Fat(BF)-For-age Z-score

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.

Time frame: 36 weeks or hospital discharge, up to 120 days following birth, whichever is longer

Anthropometric Measurements

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.

Data from ClinicalTrials.gov

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