NCT04021485: BETANINO

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

Recruiting now NA Last updated 30 September 2025

What this trial tests

NA trial testing neurodevelopmental assessment in Premature Childbirth in 643 participants. Currently enrolling.

Timeline

23 March 2022

Primary endpoint
31 October 2025

31 October 2025

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	643
Start date	23 March 2022
Primary completion	31 October 2025
Estimated completion	31 October 2025
Sites	1 location across France

Drugs / interventions tested

• neurodevelopmental assessment

Conditions studied

• Premature Childbirth — all drugs for Premature Childbirth →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 5 to 6, any sex, with Premature Childbirth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.