Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
Phase 1
Active, not recruiting
- Conditions
- Prematurity; Extreme
- Interventions
- Other: No additional vitamin D supplementationDietary Supplement: Vitamin D supplementation
- Registration Number
- NCT05615311
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 126
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group No additional vitamin D supplementation - Vitamin D group Vitamin D supplementation -
- Primary Outcome Measures
Name Time Method Severity of respiratory morbidity 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 40 - 120 days Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
- Secondary Outcome Measures
Name Time Method Bronchopulmonary dysplasia 36 weeks PMA or discharge Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States