Bronchopulmonary Dysplasia25OHVDORBPDDNCT05944055
25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death
An observational study of Bronchopulmonary Dysplasia and Vitamin D Overdose, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Vitamin D Overdose
- What is being tested?
- Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- -Infant with at least a 25OH-D below 50 nmol/L
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Bron
Sophie Laborie, MD, 04 27 85 52 84 ext. +33, sophie.laborie@chu-lyon.fr
Marine Butin, Pr, 04 27 85 52 84 ext. +33
About this study
Official title: 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.
- Conditions
- Bronchopulmonary Dysplasia, Vitamin D Overdose
- Being tested
- Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?
- Keywords
- vitamin D, Overdoses, Bronchopulmonary Dysplasia, Preterm infants
- Medical subject headings
- Bronchopulmonary Dysplasia, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ? |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary dysplasia or death
Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.
Measured: The outcome will be assessed at 36 weeks corrected age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944055
- Sponsor's protocol ID
- 69HCL23_0244
- Acronym
- 25OHVDORBPDD
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?
- ClinicalTrials.gov ID
- NCT05944055
- Acronym / sponsor ID
- 25OHVDORBPDD / 69HCL23_0244
- Conditions
- Bronchopulmonary Dysplasia, Vitamin D Overdose
- Keywords
- vitamin D, Overdoses, Bronchopulmonary Dysplasia, Preterm infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overdose | – | Biological: Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?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 |
| Control | – | 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 |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Infant with at least a 25OH-D below 50 nmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Control, Overdose |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Vitamin D Overdose, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchopulmonary dysplasia or death (time frame: The outcome will be assessed at 36 weeks corrected age.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.