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

Bronchopulmonary Dysplasia Clinical Trial

— 25OHVDORBPDD  

Official title:

Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944055
• Other study ID #: 69HCL23_0244
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 173
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Drug Overdose
• Hyperplasia

Intervention

Biological:
• Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?
Vitamin D overdose is frequent among preterm infants receiving the current supplementation (Mauras 2022, Kolodziejczyk-Nowotarska 2021). In our NICU, the protocol was to daily administrate 55 UI vitamin D during parenteral nutrition then 1000 UI during enteral nutrition for babies weighing more than 1000 g and 1200UI during enteral nutrition for babies weighing less than 1000 g. The dosage was adapted each month after a plasmatic measure of 25OH-D in order to maintain 25OH-D between 50 nmol/L and 120 nmol/L.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchopulmonary dysplasia or death	Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.	The outcome will be assessed at 36 weeks corrected age.