Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

Prematurity; Extreme Clinical Trial

Official title:

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615311
• Other study ID #: 300010307
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 16, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Ariel A. Salas, MD, MSPH
• Phone: 205-934-4680
• Email: asalas[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Prematurity; Extreme

Intervention

Dietary Supplement:
• Vitamin 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.

Other:
• No 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 - 120 days
Primary	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)	40 - 120 days
Secondary	Bronchopulmonary dysplasia	Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge	36 weeks PMA or discharge