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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Fat-free Mass(FFM)-For-age Z-score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 1 Day to 4 Days (Child)
- Sex
- 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
Arms & Interventions
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.
Intervention: Usual human milk diet (Procedure)
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.
Intervention: Protein-enriched human milk diet (Procedure)
Outcomes
Primary Outcomes
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
- Body Fat(BF)-For-age Z-score(36 weeks or hospital discharge, up to 120 days following birth, whichever is longer)
- Number of Participants With Diagnosis of Necrotizing Enterocolitis(From birth up to 120 days following birth)
- Number of Days Alive and Receiving Full Enteral Feeding(Birth to 28 days)
- Serum BUN(Birth to 28 days)
- Number of Episodes of Feeding Intolerance(Birth to 28 days)
- Duration of Hospital Stay in Days(Birth to 120 days or discharge, whichever occurs first)
- Anthropometric Measurements(Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first))
- Growth Rate(Birth to 36 weeks postmenstrual age or hospital discharge (whichever occurred first))
- Number of Participants With Postnatal Growth Failure(36 weeks or hospital discharge (whichever occurred first))
- Number of Participants With Diagnosis of Intestinal Perforation(From birth up to 120 days following birth)
- Fat Mass(FM)-For-age Z-score(36 weeks or hospital discharge, up to 120 days following birth, whichever is longer)
- Death(Birth to 120 days)
- Culture-proven Sepsis(Birth to 120 days)
Investigators
Ariel A. Salas
Principal Investigator
University of Alabama at Birmingham