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

NCT ID: NCT05944055

Last Updated: 2023-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

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

Intervention Type: 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

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

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 23 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Femme Mère Enfant

Bron, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Sophie Laborie, MD

Role: primary

sophie.laborie@chu-lyon.fr

04 27 85 52 84 ext. +33

Marine Butin, Pr

Role: backup

04 27 85 52 84 ext. +33

Other Identifiers

69HCL23_0244

Identifier Type: -

Identifier Source: org_study_id