Prematurity; Extreme
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D supplementation
Study participants assigned to the intervention group will receive 800 IU/ day of vitamin D plus 200-300 IU/day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.
OTHERNo additional vitamin D supplementation
Study participants assigned to the control group will receive 200-300 IU/ day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 4 Days
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed