RCT Results: Is a Half Dose of Antenatal Betamethasone for Preterm Delivery Non-Inferior to the Full Recommended Dosing?
BACKGROUND AND PURPOSE:
Due to concerns related to possible association between antenatal corticosteroids and adverse outcomes in offspring (e.g., growth and neurodevelopmental issues), there has been interest in reducing steroid dose
Schmitz et al. (The Lancet, 2022) investigated whether a half dose of antenatal betamethasone would be non-inferior to the current full dose for RDS prevention
Already treated with the first injection of antenatal betamethasone (11.4 mg) <32 weeks
Half dose group: Placebo as second injection 24 hrs after first
Full dose group: 11.4 mg betamethasone as second injection
1:1 randomization | Stratified by gestational age (before or after 28 weeks)
Participants, clinicians, and study staff were masked to the treatment allocation
Non-inferiority would be shown if the higher limit of the 95% CI for the between-group difference in the primary endpoint was <4 percentage points (corresponding to a maximum relative risk of 1.20)
4 interim safety analyses scheduled during the study period
Need for exogenous intratracheal surfactant within 48 hours after birth
Half dose group: 49.9% | Full dose group: 50.1%
Non-inferiority was not demonstrated for the primary outcome using intention-to-treat analysis
Half dose group: 20.0%
Full dose group: 17.5%
Risk difference 2.4% (95% CI, –0.3 to 5.2)
Non-inferiority was not demonstrated for the primary outcome using per-protocol analysis
Risk difference 2.2% (95% CI, –0.6 to 5.1)
No between-group differences were found for the rates of
Grade 3 to 4 IVH
Stage ≥2 necrotizing enterocolitis
Severe retinopathy of prematurity
This study could not demonstrate non-inferiority for using a half-dose of betamethasone for prevention of RDS among
This study did not address neurodevelopment
The authors state
Practice changes towards antenatal betamethasone dose reduction are not currently supported by our results
These should be considered as the first key but not yet sufficient step to better assess its benefit:risk ratio, not only during the neonatal period but also in childhood
Deciphering the long-term consequences of betamethasone dose reduction on neurodevelopment will be of particular importance, since the 2.4% group difference in our primary endpoint seems to be modest and because more and more foetuses are being exposed to this treatment
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