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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944055

Collaborator

(none)

173

Enrollment

Location

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia Vitamin D Overdose	Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?

Study Design

Study Type:

Observational

Anticipated Enrollment :

173 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Overdose 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	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, Kołodziejczyk-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.
Control 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	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, Kołodziejczyk-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.

Arm

Intervention/Treatment

Overdose

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

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, Kołodziejczyk-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.

Control

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

Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?

Outcome Measures

Primary Outcome Measures

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.