BETADOSE : Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicenter, double blind placebo-controlled non inferiority trial

Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial. BETADOSE - BETADOSE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001486-90-FR

Enrollment

3142

Registered

2016-04-27

Start date

2016-06-24

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very preterm birth MedDRA version: 19.0 Level: LLT Classification code 10053593 Term: Premature baby 26 to 32 weeks System Organ Class: 100000004868

Interventions

Trade Name: CELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable Product Name: CELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable Pharmaceutical Form: Suspension for injection INN or Proposed IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Singleton pregnancy - Patient who has already received the first injection of betamethasone and term pregnancy or = 18 years - Patient with health insurance coverage Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3142 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Chromosomal aberrations and major fetal malformations - Cervical dilatation > ou = 4 cm - Patient who has already received a first betamethasone course

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent severe respiratory distress syndrome (RDS) associated with very preterm birth.;Secondary Objective: To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent the other neonatal complications associated with very preterm birth.;Primary end point(s): Severe respiratory distress syndrome (RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life.;Timepoint(s) of evaluation of this end point: 48 hours	—

Measure

Time frame

Main Objective: To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent severe respiratory distress syndrome (RDS) associated with very preterm birth.;Secondary Objective: To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent the other neonatal complications associated with very preterm birth.;Primary end point(s): Severe respiratory distress syndrome (RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life.;Timepoint(s) of evaluation of this end point: 48 hours

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Secondary

Measure	Time frame
Secondary end point(s): Related to the severity of RDS - highest appropriate fractional inspired oxygen (FiO2) in the first 48 hours of life - maximum appropriate Mean Airway Pressure (MAP) - use and duration of mechanical ventilation - use and duration of oxygen therapy - need for oxygen therapy after 36 weeks post conception Related to betamethasone impact on other prematurity-induced complications - neonatal death - admission to neonatal intensive care unit - use of inotropic support - air leak syndrome - patent ducutus arteriosus - necrotising enterocolitis grade > II - intraventricular hemorrhage and its grade - periventricular leukomalacia - use of postnatal steroids - retinopathy of prematurity - length of hospital stay Related to potential adverse events - birth weight - head circonference at birth - body length at birth - early onset sepsis;Timepoint(s) of evaluation of this end point: 48 hours and 37 weeks of corrected gestational age.	—

Measure

Time frame

Secondary end point(s): Related to the severity of RDS - highest appropriate fractional inspired oxygen (FiO2) in the first 48 hours of life - maximum appropriate Mean Airway Pressure (MAP) - use and duration of mechanical ventilation - use and duration of oxygen therapy - need for oxygen therapy after 36 weeks post conception Related to betamethasone impact on other prematurity-induced complications - neonatal death - admission to neonatal intensive care unit - use of inotropic support - air leak syndrome - patent ducutus arteriosus - necrotising enterocolitis grade > II - intraventricular hemorrhage and its grade - periventricular leukomalacia - use of postnatal steroids - retinopathy of prematurity - length of hospital stay Related to potential adverse events - birth weight - head circonference at birth - body length at birth - early onset sepsis;Timepoint(s) of evaluation of this end point: 48 hours and 37 weeks of corrected gestational age.

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Countries

France

Contacts

Public ContactDRCD Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

elodie.soler@aphp.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026