Trials / Active Not Recruiting
Active Not RecruitingNCT04325308
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- University of Alabama at Birmingham · Academic / Other
- Sex
- All
- Age
- 1 Day – 4 Days
- Healthy volunteers
- Not accepted
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.
Conditions
- Prematurity; Extreme
- Feeding Disorder Neonatal
- Breast Milk Expression
- Growth Failure
- Microbial Colonization
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Protein-enriched human milk diet | 1.2 g of human-based protein will be added to each 100 ml of human milk administered |
| PROCEDURE | Usual human milk diet | Human-based protein will not be added to the human milk administered. |
Timeline
- Start date
- 2020-08-13
- Primary completion
- 2023-01-02
- Completion
- 2026-09-30
- First posted
- 2020-03-27
- Last updated
- 2025-09-23
- Results posted
- 2024-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04325308. Inclusion in this directory is not an endorsement.