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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Vitamin D Overdose; Bronchopulmonary Dysplasia

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

Study type: Observational

Funder types: Other

Identifiers

NCT05944055

69HCL23_0244

Details and patient eligibility

About

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.

Enrollment: 173 estimated patients

Sex: All

Ages: 23 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

173 participants in 2 patient groups

Overdose

Description:

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

Treatment:

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

Control

Description:

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

Treatment:

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