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Active, Not Recruiting

NCT Number: NCT04325308

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prematurity; Extreme Behavior Breast Feeding Breast Milk Expression Communicable Diseases Disease Attributes Failure to Thrive Feeding Behavior Feeding Disorder Neonatal Female Urogenital Diseases and Pregnancy Complications Growth Failure Infections Microbial Colonization Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein-enriched human milk diet

Procedure

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

Usual human milk diet

Procedure

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Anthropometric Measurements

    Time frame: 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.

  4. Growth Rate

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first)

    Weight gain in g/kg/day

  5. Number of Participants With Postnatal Growth Failure

    Time frame: 36 weeks or hospital discharge (whichever occurred first)

    Diagnosis of growth failure (weight < 10th percentile using the 2013 Fenton growth curves)

  6. Number of Participants With Diagnosis of Necrotizing Enterocolitis

    Time frame: From birth up to 120 days following birth

    Diagnosis of necrotizing enterocolitis stage 2 or 3

  7. Number of Participants With Diagnosis of Intestinal Perforation

    Time frame: From birth up to 120 days following birth

    Diagnosis of intestinal perforation

  8. Death

    Time frame: Birth to 120 days

    Death prior to 121 days of life

  9. Culture-proven Sepsis

    Time frame: Birth to 120 days

    Diagnosis of sepsis with positive blood cultures

  10. Number of Days Alive and Receiving Full Enteral Feeding

    Time frame: Birth to 28 days

    Time to full enteral feeding days

  11. Number of Episodes of Feeding Intolerance

    Time frame: Birth to 28 days

    Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination

  12. Duration of Hospital Stay in Days

    Time frame: Birth to 120 days or discharge, whichever occurs first

    From day of admission to day of hospital discharge to home

  13. Serum BUN

    Time frame: Birth to 28 days

    Highest serum BUN value in the first 28 days after birth

Other outcomes

  1. Changes in Intestinal Microbiome

    Time frame: Birth to 36 weeks postmenstrual age

    Determined by molecular analyses of fecal samples

  2. Cognitive Outcomes

    Time frame: 2 years of corrected age

    Determined by Bayley assessment

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
Mar 27, 2020
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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