BETAmethasone Dose Reduction: Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation

Recruiting now · Not applicable

Conditions studied: Premature Childbirth

In brief

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.

Key facts

Study ID

NCT04021485

Run by

Assistance Publique - Hôpitaux de Paris

People needed

643

Starts

2022-03-23

Expected to finish

2025-10-31

Last updated by the study team

2025-09-30

Who can join

Age: 5 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Major malformations and chromosomal aberrations evidenced after birth,
• Parents' refuse to participate.

Where it is running

• Hôpital Robert Debré — Paris, Pa, France (enrolling)

Full record on ClinicalTrials.gov

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