An observational study in Bronchopulmonary Dysplasia and Vitamin D Overdose, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 23 Weeks to 31 Weeks. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Hospices Civils de Lyon · Observational
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's planned enrollment of 173 is above the median of 137 across 92 observational studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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.
Inclusion Criteria:
Exclusion Criteria:
-Infant with at least a 25OH-D below 50 nmol/L
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 ?
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.
Bronchopulmonary dysplasia or death
Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.
Time frame: The outcome will be assessed at 36 weeks corrected age.
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Hospices Civils de Lyon