25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death (25OHVDORBPDD)
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| ClinicalTrials.gov Identifier: NCT05944055 |
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Recruitment Status :
Recruiting
First Posted : July 13, 2023
Last Update Posted : July 17, 2023
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Bronchopulmonary Dysplasia Vitamin D Overdose | Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ? |
| Study Type : | Observational |
| Estimated Enrollment : | 173 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ? |
| Actual Study Start Date : | January 1, 2023 |
| Actual Primary Completion Date : | June 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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
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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. |
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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. |
- Bronchopulmonary dysplasia or death [ Time Frame: The outcome will be assessed at 36 weeks corrected age. ]Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.
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| Ages Eligible for Study: | 23 Weeks to 31 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05944055
| France | |
| Hôpital Femme Mère Enfant | Recruiting |
| Bron, France | |
| Contact: Sophie Laborie, MD 04 27 85 52 84 ext +33 sophie.laborie@chu-lyon.fr | |
| Contact: Marine Butin, Pr 04 27 85 52 84 ext +33 | |
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT05944055 |
| Other Study ID Numbers: |
69HCL23_0244 |
| First Posted: | July 13, 2023 Key Record Dates |
| Last Update Posted: | July 17, 2023 |
| Last Verified: | July 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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vitamin D Overdoses Bronchopulmonary Dysplasia Preterm infants |
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Bronchopulmonary Dysplasia Hyperplasia Drug Overdose Pathologic Processes Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |
Prescription Drug Misuse Drug Misuse Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |