Using betamethasone to help close the ductus arteriosus in premature infants
Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants
Hospices Civils de Lyon · NCT05987202
This study tests if giving betamethasone can help close a heart vessel in very premature babies who are having trouble with their breathing.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05987202 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of betamethasone in promoting the closure of the ductus arteriosus (DA) in very preterm infants who are hospitalized. Persistent ductus arteriosus is a common condition in this population, leading to serious health complications. The study focuses on infants born between January 2018 and December 2022, who are treated for bronchopulmonary dysplasia and have a hemodynamically significant DA. The goal is to assess the outcomes of DA closure following betamethasone treatment.
Who should consider this trial
Good fit: Ideal candidates are premature infants born before 37 weeks of gestation, hospitalized in the Neonatal unit of Croix-Rousse hospital, and treated for bronchopulmonary dysplasia.
Not a fit: Patients who have already closed their ductus arteriosus before receiving betamethasone or those who died before or during treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for surgical interventions and improve health outcomes for premature infants with persistent ductus arteriosus.
How similar studies have performed: While the use of betamethasone in this context is not widely established, similar approaches in managing persistent ductus arteriosus have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria : * 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 * Exclusion Criteria : * Children having closed their ductus arteriosus before administration of the betamethasone course * Children who died before or during treatment.
Where this trial is running
Lyon
- Service de Réanimation néonatale - Hôpital de la Croix Rousse — Lyon, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Ductus Arteriosus, Prematurity, Ductus arteriosus, Steroids, Betamethasone, Bronchopulmonary dysplasia