Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Microbial Colonization Clinical Trial

Official title:

Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04325308
• Other study ID #: 300005089
• Secondary ID: K23HD102554
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Breast Milk Expression
• Communicable Diseases
• Failure to Thrive
• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Growth Failure
• Infections
• Microbial Colonization
• Prematurity; Extreme

Intervention

Procedure:
• Protein-enriched human milk diet
1.2 g of human-based protein will be added to each 100 ml of human milk administered
• Usual human milk diet
Human-based protein will not be added to the human milk administered.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Salas AA, Gunawan E, Nguyen K, Reeves A, Argent V, Finck A, Carlo WA. Early Human Milk Fortification in Infants Born Extremely Preterm: A Randomized Trial. Pediatrics. 2023 Sep 1;152(3):e2023061603. doi: 10.1542/peds.2023-061603. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Intestinal Microbiome	Determined by molecular analyses of fecal samples	Birth to 36 weeks postmenstrual age
Other	Cognitive Outcomes	Determined by Bayley assessment	2 years of corrected age
Primary	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.	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	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.	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	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.	36 weeks or hospital discharge, up to 120 days following birth, whichever is longer
Secondary	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.	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
Secondary	Growth Rate	Weight gain in g/kg/day	Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)
Secondary	Number of Participants With Postnatal Growth Failure	Diagnosis of growth failure (weight < 10th percentile using the 2013 Fenton growth curves)	36 weeks or hospital discharge (whichever occurred first)
Secondary	Number of Participants With Diagnosis of Necrotizing Enterocolitis	Diagnosis of necrotizing enterocolitis stage 2 or 3	From birth up to 120 days following birth
Secondary	Number of Participants With Diagnosis of Intestinal Perforation	Diagnosis of intestinal perforation	From birth up to 120 days following birth
Secondary	Death	Death prior to 121 days of life	Birth to 120 days
Secondary	Culture-proven Sepsis	Diagnosis of sepsis with positive blood cultures	Birth to 120 days
Secondary	Number of Days Alive and Receiving Full Enteral Feeding	Time to full enteral feeding days	Birth to 28 days
Secondary	Number of Episodes of Feeding Intolerance	Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination	Birth to 28 days
Secondary	Duration of Hospital Stay in Days	From day of admission to day of hospital discharge to home	Birth to 120 days or discharge, whichever occurs first
Secondary	Serum BUN	Highest serum BUN value in the first 28 days after birth	Birth to 28 days