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

NCT04021485 | Recruiting

• 1 other identifier: K170920J
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• neurocognitive development

  Cognition will be assessed by certified neuropsychologists at 5 years of age using full scale IQ generated by Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) test.

  5 years

Secondary Outcomes (6)

• 5-year survival without moderate-to-severe impairment

  5 years

• neurocognitive development

  5 years

• Parental stress

  5 years

• Parental stress

  5 years

• cerebral palsy

  5 years

Study Arms (1)

neurodevelopmental assessment

OTHER

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

Other: neurodevelopmental assessment

Interventions

neurodevelopmental assessment OTHER

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

neurodevelopmental assessment

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert Debré

Paris, Pa, 75019, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Biran Valerie, PHD

  APHP

  PRINCIPAL INVESTIGATOR

• Baud Olivier, PHD

  Hôpitaux Universitaires de Genève - Inserm U1141 Hôpital Robert Debré

  STUDY CHAIR

• Schmitz Thomas, PHD

  APHP

  STUDY CHAIR

Central Study Contacts

Biran Valérie, PHD

CONTACT

01 40 03 41 91; valerie.biran@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 16, 2019
• Study Start: March 23, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

FR (1)