Bronchopulmonary DysplasiaDEPRECODNCT05055193
Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Extremely preterm infants less than 29 weeks' gestation
Who may be able to join
- Extremely preterm infants less than 29 weeks' gestation
- Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
- Infants born between January 1, 2013 and December 31, 2016
Who cannot join
- Infants with a congenital heart, lung or brain malformation
- Infants with a neuromuscular disease
- Infants with a genetic disorder
- Infants who died before the age of 24 months corrected age
- Infants lost to follow-up or with incomplete data at 24 months corrected age
Trial locations and contacts
1 site in 1 country.
About this study
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcomeDrug
Data concerning the 24 months corrected age outcomes were collected from the medical records of the ECL'AUR preterm infants follow-up network.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia | Corticosteroids used are hydrocortisone (as first-line therapy) and betamethasone (in situations of particular severity) Receives: Drug: Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome | |
| Preterm infants who did not receive postnatal corticosteroid for bronchopulmonary dysplasia | No corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age
- Respiratory evolution at 24 months corrected age: asthma, inhaled corticosteroid therapy, respiratory events, hospitalizations for respiratory events.
- Neurodevelopmental evolution at 24 months corrected age: developmental quotient of the revised Brunet Lézine scale, visual and auditory anomalies, cerebral palsy.
- Growth evolution at 24 months corrected age: weight, height and head circumference at 24 months.
Measured: at 24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Jan 2013
- Primary completion1 Jan 2013
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 400 participants (actual)
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
- NCT05055193
- Sponsor's protocol ID
- CRC_GHN_2021_005
- Acronym
- DEPRECOD
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Melan N, Pradat P, Godbert I, Pastor-Diez B, Basson E, Picaud JC. Neurodevelopment at 24 months corrected age in extremely preterm infants treated with dexamethasone alternatives during the late postnatal period: a cohort study. Eur J Pediatr. 2024 Feb;183(2):677-687. doi: 10.1007/s00431-023-05319-z. Epub 2023 Nov 13.
PubMed 37955745
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT05055193
- Acronym / sponsor ID
- DEPRECOD / CRC_GHN_2021_005
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Sep 2021 (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.
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia | – | Drug: Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcomeCorticosteroids used are hydrocortisone (as first-line therapy) and betamethasone (in situations of particular severity) |
| Preterm infants who did not receive postnatal corticosteroid for bronchopulmonary dysplasia | – | –No corticosteroids |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Extremely preterm infants less than 29 weeks' gestation
Key inclusion criteria (3 listed)
- Extremely preterm infants less than 29 weeks' gestation
- Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
- Infants born between January 1, 2013 and December 31, 2016
Key exclusion criteria (5 listed)
- Infants with a congenital heart, lung or brain malformation
- Infants with a neuromuscular disease
- Infants with a genetic disorder
- Infants who died before the age of 24 months corrected age
- Infants lost to follow-up or with incomplete data at 24 months corrected age
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 |
|---|---|---|
| Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcomeData concerning the 24 months corrected age outcomes were collected from the medical records of the ECL'AUR preterm infants follow-up network. | Drug | Preterm infants who received postnatal corticosteroid for bronchopulmonary dysplasia |
Primary outcome
Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age
Time frame: at 24 months corrected age
* Respiratory evolution at 24 months corrected age: asthma, inhaled corticosteroid therapy, respiratory events, hospitalizations for respiratory events. * Neurodevelopmental evolution at 24 months corrected age: developmental quotient of the revised Brunet Lézine scale, visual and auditory anomalies, cerebral palsy. * Growth evolution at 24 months corrected age: weight, height and head circumference at 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 37955745Melan N, Pradat P, Godbert I, Pastor-Diez B, Basson E, Picaud JC. Neurodevelopment at 24 months corrected age in extremely preterm infants treated with dexamethasone alternatives during the late postnatal period: a cohort study. Eur J Pediatr. 2024 Feb;183(2):677-687. doi: 10.1007/s00431-023-05319-z. Epub 2023 Nov 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 5 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: finished, as of the sponsor's last update on 24 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age (time frame: at 24 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055193, which also lists 1 linked publication.
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 24 Sep 2021.