Background
Preterm birth and antenatal corticosteroids
Corticosteroid type and regimen in current clinical practice
Evidence from non-randomised cohort studies using dexamethasone or betamethasone
Appraising the evidence - the cochrane review
Evidence from randomised controlled trials using dexamethasone or betamethasone: effect on childhood health - reduction in neurosensory disability
Evidence from randomised trials: direct comparison of dexamethasone with betamethasone
Aims and objectives of this trial
Hypotheses
Methods/Design
Ethics statement
Study design
Inclusion criteria
Exclusion criteria
Trial entry
Study groups
Dexamethasone study group
Betamethasone study group
Both study groups
Follow up after birth until the time of primary discharge for both groups
Longer term follow up
Two years assessments
Motor function
Psychological assessments
Behaviour
General health, health resource utilisation, blood pressure, body size, and quality of life
Categorisation of neurosensory disability
Severe disability
| Any severe cerebral palsy (child non-ambulant and likely to remain so; GMFCS level 4 or 5), severe developmental delay (standardised score <−3 SD) or blindness. |
Moderate disability
| Moderate cerebral palsy (child non-ambulant at 2 years of age but who is likely to ambulate subsequently; GMFCS level 2 or 3), or deafness, or moderate developmental delay (standardised score from −3 SD to <−2 SD). |
Mild disability
| Mild cerebral palsy (child walking at 2 years of age with only minimal limitation of movement (GMFCS level 1), or suspect developmental delay (standardised score from −2 SD to <−1 SD). |
No neurosensory disability
| Children without any neurosensory impairment. |
Primary study endpoints
Secondary study endpoints
For the infant/child
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Death or major neurosensory disability (with major neurosensory disability defined as severe and moderate disability and includes blindness, deafness, cerebral palsy in a child non-ambulant by two years of age or a standardised score <−2 SD).
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Individual components and severity of the primary outcome (death, cerebral palsy, blindness, deafness, developmental delay).
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Neonatal outcomes measured prior to primary hospital discharge, including IVH, severe IVH (Grade 3 or 4), periventricular leukomalacia, retinopathy of prematurity needing treatment, patent ductus arteriosus needing treatment, respiratory distress syndrome, severity of any neonatal lung disease, chronic lung disease (need for oxygen at 36 weeks post-menstrual age or 28 days of life if born after 32 weeks gestation), use of mechanical ventilation, confirmed infection within the first 48 hours, infection after the first 48 hours, proven necrotising enterocolitis, body size at birth (weight, length and head circumference) and at discharge home after birth.
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Childhood outcomes assessed at two years’ corrected age including body size and corresponding Z scores, general health of the child (including use of health services since primary hospitalisation), childhood respiratory morbidity, blood pressure Z scores and proportions in hypertensive ranges and behaviour as assessed by the Child Behaviour Checklist [40].
For the mother
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Maternal perinatal infectious morbidity (defined as clinical chorioamnionitis requiring intrapartum antibiotics and/or use of postpartum antibiotics).
Sample size
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a decrease in the combined outcome of death or neurosensory disability from 27.0% to 20.1% (Absolute Risk Difference (ARD) 6.9%; Relative Risk Difference (RRD) 25.6%) with dexamethasone compared with betamethasone, or;
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an increase from 27.0% to 34.5% (ARD 7.5%; RRD 27.8%).