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

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 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.

Conditions

• Premature Childbirth

Interventions

OTHER

neurodevelopmental assessment

As part of the usual follow-up of premature children, a follow-up consultation is planned around the age of 5 years. During this visit, a neurodevelopmental assessment will be carried out for the Betanino study. The duration of this evaluation is evaluated around 3h in total. Interventions will include: * Standardized neurological exam * Morphometric measurements including height, weight, head circumference * Blood pressure measurement * Multiple aspects of cognition using ancillary indexes of WPPSI-IV subtests, NEPSY-II subtests, * Social Relativeness, using Social Relativeness Scale parental questionnaire, * Parental stress using PSI questionnaire

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Biran Valerie, PHD · APHP

• Baud Olivier, PHD · Hôpitaux Universitaires de Genève - Inserm U1141 Hôpital Robert Debré

• Schmitz Thomas, PHD · APHP

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

5 Years

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-23

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• France

Study Locations