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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 173

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Recruiting
    • Hôpital Femme Mère Enfant
    • Contact: Sophie Laborie, MD; Phone Number: +33 04 27 85 52 84; Email: sophie.laborie@chu-lyon.fr
    • Contact: Marine Butin, Pr; Phone Number: +33 04 27 85 52 84

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infants hospitalized in the NICU at Hôpital Femme Mère Enfant, Bron, France. With a measure of 25OHD each month from the first month of life, as routinely recommended in this NICU.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: vitamin D; Preterm infants; Bronchopulmonary Dysplasia; Overdoses
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Hyperplasia; Bronchopulmonary Dysplasia; Drug Overdose; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 69HCL23_0244

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No