Reducing betamethasone dosage for neurocognitive outcomes in preterm infants
5-year Follow-up of the BETADOSE Trial: Non-inferiority of a 50% Dose Reduction of Antenatal Betamethasone Therapy on the Neurodevelopment of Children Born Before 32 Weeks of Gestation.
This study tests if giving a lower dose of betamethasone to preterm infants can still help prevent learning and development problems as they grow up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 643 (estimated) |
| Ages | 5 Years to 6 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Pa) |
| Trial ID | NCT04021485 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether a reduced dosage of betamethasone, a corticosteroid used in antenatal therapy, is as effective as the standard dosage in preventing neurodevelopmental impairments in children born before 32 weeks of gestation. The study focuses on children aged 5 to 6 years who were part of a previous trial assessing the impact of betamethasone on respiratory distress syndrome. By comparing neurocognitive outcomes, the trial aims to determine if lower doses can provide similar benefits while minimizing potential risks associated with higher doses. The research is conducted at Hôpital Robert Debré in Paris, France.
Who should consider this trial
Good fit: Ideal candidates are singleton children born before 32 weeks of gestation who are currently aged between 5 and 6 years.
Not a fit: Patients with major malformations or chromosomal aberrations, or whose parents refuse participation, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer antenatal corticosteroid protocols that reduce the risk of neurodevelopmental issues in preterm infants.
How similar studies have performed: Other studies have shown promising results with reduced corticosteroid dosages, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Singleton child born from mother enrolled in the BETADOSE trial, * Gestational age at birth less than 32 weeks of gestation, * Age ≥ 5 years and \< 6 years, alive and not lost of follow up * Informed consent of the holder (s) of the exercise of parental authority * Affiliation to a social security scheme. Exclusion Criteria: * Major malformations and chromosomal aberrations evidenced after birth, * Parents' refuse to participate.
Where this trial is running
Paris, Pa
- Hôpital Robert Debré — Paris, Pa, France (Recruiting)
Study contacts
- Principal investigator: Biran Valerie, PHD — Aphp
- Study coordinator: Biran Valérie, PHD
- Email: valerie.biran@aphp.fr
- Phone: 01 40 03 41 91
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.