Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Purpose
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.
Conditions
- Prematurity; Extreme
- Feeding Disorder Neonatal
- Breast Milk Expression
- Growth Failure
- Microbial Colonization
Eligibility
- Eligible Ages
- Between 1 Day and 4 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Protein-enriched human milk diet |
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth. |
|
|
Active Comparator Usual human milk diet |
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- University of Alabama at Birmingham
Study Contact
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.