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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
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.
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.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Severity of respiratory morbidity
A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen
Time frame: 0 - 120 days
Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
Time frame: 40 - 120 days
Bronchopulmonary dysplasia
Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge
Time frame: 36 weeks PMA or discharge
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