Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Severity of respiratory morbidity
Study Overview
Brief Summary
This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 4 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Gestational age of 28 weeks or less
Exclusion Criteria
- •Major congenital anomalies and infants
- •Terminal illness in whom decisions to withhold or limit life support have been made
Arms & Interventions
Control group
Intervention: No additional vitamin D supplementation (Other)
Vitamin D group
Intervention: Vitamin D supplementation (Dietary Supplement)
Outcomes
Primary Outcomes
Severity of respiratory morbidity
Time Frame: 0 - 120 days
A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen
Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
Time Frame: 40 - 120 days
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
Secondary Outcomes
- Bronchopulmonary dysplasia(36 weeks PMA or discharge)
Investigators
Ariel A. Salas
Associate Professor
University of Alabama at Birmingham