Persistent Ductus ArteriosusCELESTENCT05987202
Betamethasone and Closure of Ductus Arteriosus
An observational study of Persistent Ductus Arteriosus, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality: prolongation of respiratory assistance, pulmonary haemorrhage, -necrotizing enterocolitis (NECU)… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Persistent Ductus Arteriosus
- What is being tested?
- DA closure in a population of premature infants
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 1 Dec 2024
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born between january 2018 and December 2022, at a gestational age below 37 weeks, hospitalized in the Neonatal unit of Croix-Rousse hospital, presenting an hemodynamically significant DA and treated by BTM for bronchopulmonary dysplasia
Who may be able to join
- born between January 2018 and December 2022
- at a gestational age below 37 weeks,
- hospitalized in the Neonatal unit of Croix-Rousse hospital,
- presenting a hemodynamically significant DA
- treated by BTM for bronchopulmonary dysplasia
Who cannot join
- Children having closed their ductus arteriosus before administration of the betamethasone course
- Children who died before or during treatment.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Réanimation néonatale - Hôpital de la Croix Rousse
Lyon, 69317
Jean-Charles PICAUD, Pr, 04 72 00 41 24 ext. +33, jean-charles.picaud@chu-lyon.fr
About this study
Official title: Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality: prolongation of respiratory assistance, pulmonary haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death.
PDA management is one of the most discussed aspects in neonatology. The treatment is either conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the most immature children. When medical treatment fails, surgical or endovascular treatment is considered. However, these are associated with complications such as recurrent nerve lesion, thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient.
Read more
The main complication of CAP is the impossibility of weaning the patient from ventilatory assistance. On the one hand because of PDA, but also very often because of the concomitant development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations.
The most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most widely used product worldwide, but its use is associated with impaired postnatal growth and suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has been used less than the other products because it is not widely available in some countries. Its advantage is that it can be given orally, but there is little published data on the effect of BTM. In this context, it has been used in some neonatal units and have shown some effectiveness.
In the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005 and has been evaluated favorably, since it allows the child to be weaned from ventilatory assistance. When using BTM, we observed not only a positive respiratory effect, but also DA closure, reducing the need for ligation of the ductus arteriosus by surgery or catheterization
- Conditions
- Persistent Ductus Arteriosus
- Being tested
- DA closure in a population of premature infants
- Keywords
- Prematurity, Ductus arteriosus, Steroids, Betamethasone, Bronchopulmonary dysplasia
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA closure in a population of premature infantsOther
Evaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants born between January 1st, 2018 and December 31st, 2022 | All infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA Receives: Other: DA closure in a population of premature infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with favorable evolution of the CAP
Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion1 Dec 2024 (estimated)
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 Persistent Ductus ArteriosusStudies 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
- 51 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
- NCT05987202
- Sponsor's protocol ID
- 69HCL23_0779
- Acronym
- CELESTE
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Remy A, Vincent M, Pastor-Diez B, Picaud JC. Late postnatal steroid treatment using oral betamethasone can help to close ductus arteriosus in extremely preterm infants who cannot be weaned from ventilation. Eur J Pediatr. 2024 Nov 28;184(1):50. doi: 10.1007/s00431-024-05840-9.
PubMed 39604779
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants
- ClinicalTrials.gov ID
- NCT05987202
- Acronym / sponsor ID
- CELESTE / 69HCL23_0779
- Conditions
- Persistent Ductus Arteriosus
- Keywords
- Prematurity, Ductus arteriosus, Steroids, Betamethasone, Bronchopulmonary dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Aug 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.
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality: prolongation of respiratory assistance, pulmonary haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death.
PDA management is one of the most discussed aspects in neonatology. The treatment is either conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the most immature children. When medical treatment fails, surgical or endovascular treatment is considered. However, these are associated with complications such as recurrent nerve lesion, thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient.
The main complication of CAP is the impossibility of weaning the patient from ventilatory assistance. On the one hand because of PDA, but also very often because of the concomitant development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations.
The most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most widely used product worldwide, but its use is associated with impaired postnatal growth and suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has been used less than the other products because it is not widely available in some countries. Its advantage is that it can be given orally, but there is little published data on the effect of BTM. In this context, it has been used in some neonatal units and have shown some effectiveness.
In the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005 and has been evaluated favorably, since it allows the child to be weaned from ventilatory assistance. When using BTM, we observed not only a positive respiratory effect, but also DA closure, reducing the need for ligation of the ductus arteriosus by surgery or catheterization
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants born between January 1st, 2018 and December 31st, 2022 | – | Other: DA closure in a population of premature infantsAll infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born between january 2018 and December 2022, at a gestational age below 37 weeks, hospitalized in the Neonatal unit of Croix-Rousse hospital, presenting an hemodynamically significant DA and treated by BTM for bronchopulmonary dysplasia
Key inclusion criteria (5 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| DA closure in a population of premature infantsEvaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia | Other | Preterm infants born between January 1st, 2018 and December 31st, 2022 |
Primary outcome
Number of children with favorable evolution of the CAP
Time frame: through study completion, an average of 6 months
Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 39604779Remy A, Vincent M, Pastor-Diez B, Picaud JC. Late postnatal steroid treatment using oral betamethasone can help to close ductus arteriosus in extremely preterm infants who cannot be weaned from ventilation. Eur J Pediatr. 2024 Nov 28;184(1):50. doi: 10.1007/s00431-024-05840-9.
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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.
Service de Réanimation néonatale - Hôpital de la Croix Rousse
Lyon, France
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 Persistent Ductus Arteriosus, 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 5 inclusion and 2 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 18 Jan 2024. 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?
Number of children with favorable evolution of the CAP (time frame: through study completion, an average of 6 months). 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 NCT05987202, 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 18 Jan 2024.