25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death

Recruiting

• Conditions: Vitamin D Overdose; Bronchopulmonary Dysplasia
• Interventions: Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?

• Registration Number: NCT05944055
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an increased mortality and an increased lung injury. Such vitamin D overdose has been frequently reported in hospitalized neonates receiving the current supplementation.

The hypothesis is that vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among infants born below 31 weeks gestational age excluding infants with vitamin D deficiency.

This retrospective cohort study will include all infants born before 31 weeks of gestation (WG), who were hospitalized in a tertiary neonatal intensive care unit (NICU) during at least 10 days, for who at least one 25OH vitamin D determination was performed before 36 WG corrected age and whose parents are not opposed to the study. A descriptive analysis of the cohort depending on the occurrence of vitamin D overdose will be performed. A multivariate analysis will determine if vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among preterm infants, adjusting on the covariates known to be associated with bronchopulmonary dysplasia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-06-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-13
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Inclusion Criteria * :
• Infant born before 31 weeks of gestation.
• hospitalized in the NICU during at least 10 days
• with at least a 25OH-D determination available before 36 weeks corrected age

Exclusion Criteria

-Infant with at least a 25OH-D below 50 nmol/L

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overdose	Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?	Preterm born before 31 weeks of gestation with at least a 25OH-D measure above 120nmol/L before 36 weeks corrected age and no determination below 50nmol/L. Of note, 25OH-D determinations are routinely performed each month from the first month of life during the NICU hospitalization
Control	Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?	Preterm infants born before 31 weeks of gestation, who presented with a 25OH-D between 50 and 120nmol/L for all the 25OH-D measures during their hospitalization in the NICU setting. Of note, 25OH-D determinations are routinely performed each month from the first month of life during the NICU hospitalization

Primary Outcome Measures

Name	Time	Method
Bronchopulmonary dysplasia or death	The outcome will be assessed at 36 weeks corrected age.	Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France