Informations générales (source: ClinicalTrials.gov)
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.
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2022
octobre 2025
02 octobre 2025
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 outcomes in infants exposed to antenatal steroids have been
assessed in few cohorts and suggest that this therapy is able to prevent some
neurodevelopmental impairments including cerebral palsy. While >85% of neonates born very
preterm in Europe have been exposed to antenatal betamethasone, Cochrane collaborative
networks stated that trials of dosages comparing different regimens of commonly used
corticosteroids are most urgently needed to avoid useless fetal exposure to excessive
dosage of corticosteroids.
- Because a half dosage was associated with maximal benefits on lung function in ewes,
a randomized controlled trial (BETADOSE, NCT02897076) has been conducted to
demonstrate that a 50% reduced betamethasone dose regimen is not inferior to a full
dose to prevent respiratory distress syndrome in preterm neonates. BETADOSE trial
demonstrated that half dose did not show noninferiority to full antenatal
betamethasone dose regimen to prevent severe RDS in preterm neonates while other
prematurity-associated complications, including those usually prevented by ACS, did
not differ between the two groups.
- Results of the 5-year BETANINO follow-up study of the BETADOSE neonates are needed
before deciding whether reducing ACS dose is possible The main hypothesis of
BETANINO is that half dose regimen of betamethasone is not inferior to full dose
regimen of betamethasone to prevent neurodevelopmental impairments in these
high-risk children born very preterm at 5 years of age.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:43:31 | Contacter | |||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Robert Debré | |||||
| AP-HP - Hôpital Robert Debré | |||||
Critères
Tous
- 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.