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Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Primary Purpose

Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein-enriched human milk diet
Usual human milk diet
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prematurity; Extreme

Eligibility Criteria

1 Day - 4 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protein-enriched human milk diet

Usual human milk diet

Arm Description

Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.

Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.

Outcomes

Primary Outcome Measures

Fat-free mass(FFM)-for-age Z-score
FFM accretion will be estimated by air displacement plethysmography

Secondary Outcome Measures

Fat mass(FM)-for-age Z-score
FM accretion will be estimated by air displacement plethysmography
Body fat(BF)-for-age Z-score
Percent BF will be estimated by air displacement plethysmography
Anthropometric measurements
Weight, length, and head circumference measurements at regular intervals
Growth rate
Weight gain in g/kg/day
Number of participants with postnatal growth failure
Diagnosis of growth failure (weight < 10th percentile)
Number of participants with diagnosis of necrotizing enterocolitis
Diagnosis of necrotizing enterocolitis stage 2 or 3
Number of participants with diagnosis of intestinal perforation
Diagnosis of intestinal perforation
Death
Death prior to 121 days of birth
Culture-proven sepsis
Diagnosis of sepsis with positive blood cultures
Number of days alive and receiving full enteral feeding
Total number of full enteral feeding days
Number of episodes of feeding intolerance
Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
Duration of hospital stay in days
From day of admission to day of hospital discharge to home
Serum creatinine
Highest serum creatinine value in the first 28 days after birth

Full Information

First Posted
March 25, 2020
Last Updated
September 28, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04325308
Brief Title
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Extreme, Feeding Disorder Neonatal, Breast Milk Expression, Growth Failure, Microbial Colonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Caregivers and primary outcome evaluators will be masked. Nutrition room staff not involved in patient care will be responsible for determining participant allocation to one of the supplementation groups by opening sequentially numbered sealed envelopes, dispensing feeding syringes with the allocated human milk diet (protein-enriched or usual), and masking caregivers administering the assigned dietary intervention.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein-enriched human milk diet
Arm Type
Experimental
Arm Description
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
Arm Title
Usual human milk diet
Arm Type
Active Comparator
Arm Description
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.
Intervention Type
Procedure
Intervention Name(s)
Protein-enriched human milk diet
Intervention Description
1.2 g of human-based protein will be added to each 100 ml of human milk administered
Intervention Type
Procedure
Intervention Name(s)
Usual human milk diet
Intervention Description
Human-based protein will not be added to the human milk administered.
Primary Outcome Measure Information:
Title
Fat-free mass(FFM)-for-age Z-score
Description
FFM accretion will be estimated by air displacement plethysmography
Time Frame
36 weeks or hospital discharge
Secondary Outcome Measure Information:
Title
Fat mass(FM)-for-age Z-score
Description
FM accretion will be estimated by air displacement plethysmography
Time Frame
36 weeks or hospital discharge
Title
Body fat(BF)-for-age Z-score
Description
Percent BF will be estimated by air displacement plethysmography
Time Frame
36 weeks or hospital discharge
Title
Anthropometric measurements
Description
Weight, length, and head circumference measurements at regular intervals
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Growth rate
Description
Weight gain in g/kg/day
Time Frame
Birth to 36 weeks postmenstrual age or hospital discharge
Title
Number of participants with postnatal growth failure
Description
Diagnosis of growth failure (weight < 10th percentile)
Time Frame
36 weeks or hospital discharge
Title
Number of participants with diagnosis of necrotizing enterocolitis
Description
Diagnosis of necrotizing enterocolitis stage 2 or 3
Time Frame
Birth to 120 days or discharge, whichever occurs first
Title
Number of participants with diagnosis of intestinal perforation
Description
Diagnosis of intestinal perforation
Time Frame
Birth to 120 days or discharge, whichever occurs first
Title
Death
Description
Death prior to 121 days of birth
Time Frame
Birth to 120 days
Title
Culture-proven sepsis
Description
Diagnosis of sepsis with positive blood cultures
Time Frame
Birth to 120 days
Title
Number of days alive and receiving full enteral feeding
Description
Total number of full enteral feeding days
Time Frame
Birth to 28 days
Title
Number of episodes of feeding intolerance
Description
Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination
Time Frame
Birth to 28 days
Title
Duration of hospital stay in days
Description
From day of admission to day of hospital discharge to home
Time Frame
Birth to 120 days or discharge, whichever occurs first
Title
Serum creatinine
Description
Highest serum creatinine value in the first 28 days after birth
Time Frame
Birth to 28 days
Other Pre-specified Outcome Measures:
Title
Changes in intestinal microbiome
Description
Determined by molecular analyses of fecal samples
Time Frame
Birth to 36 weeks postmenstrual age
Title
Cognitive outcomes
Description
Determined by Bayley assessment
Time Frame
2 years of corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Salas, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37551512
Citation
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.
Results Reference
result

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Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

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