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

NCT05944055 | Unknown

• 1 other identifier: 69HCL23_0244
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Vitamin D Overdose

Keywords

vitamin D; Overdoses; Bronchopulmonary Dysplasia; Preterm infants

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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 ?

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 ?

Interventions

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

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; Overdose

Eligibility Criteria

• Age: 23 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Drug Overdose

Interventions

Death Domain

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Death Domain Superfamily; Protein Interaction Domains and Motifs; Protein Domains; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

FR (1)