Back to resultsRespiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
Primary Purpose
Prematurity; Extreme
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D supplementation
No additional vitamin D supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity; Extreme
Eligibility Criteria
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
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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
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)
Secondary Outcome Measures
Bronchopulmonary dysplasia
Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge
Full Information
NCT ID
NCT05615311
First Posted
November 3, 2022
Last Updated
April 22, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT05615311
Brief Title
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
Official Title
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity; Extreme
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplementation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No additional vitamin D supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of respiratory morbidity
Description
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
Title
Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
Description
Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)
Time Frame
40 - 120 days
Secondary Outcome Measure Information:
Title
Bronchopulmonary dysplasia
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel A. Salas, MD, MSPH
Phone
205-934-4680
Email
asalas@uab.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariel A. Salas, MD, MSPH
12. IPD Sharing Statement
Learn more about this trial
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
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