Status:
RECRUITING
BETAmethasone Dose Reduction: Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Premature Childbirth
Eligibility:
All Genders
5-6 years
Phase:
NA
Brief Summary
Maternal antenatal corticosteroid therapy is the last major advance in the antenatal management of fetuses to prevent neonatal complications associated with prematurity. Long-term neurological outcome...
Detailed Description
Maternal antenatal corticosteroids (ACS) therapy is considered to be the last major advance in the antenatal management of fetuses at risk of preterm birth. It was adopted worldwide to prevent neonata...
Eligibility Criteria
Inclusion
- 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
- Major malformations and chromosomal aberrations evidenced after birth,
- Parents' refuse to participate.
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT04021485
Start Date
March 23 2022
End Date
October 31 2025
Last Update
September 30 2025
Active Locations (1)
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1
Hôpital Robert Debré
Paris, Pa, France, 75019