ALPS (follow-up)
Trial question
What is the effect of antenatal corticosteroids in children born to mothers at risk of late preterm delivery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 1026
1026 patients (470 female, 556 male).
Inclusion criteria: children, aged ≥ 6 years, born to mothers at high risk of preterm delivery from 34-36 completed weeks.
Key exclusion criteria: unable to participate in a study visit or if the family declines future contact or participation; neonatal or infant death; custody issues; presence of any neurocognitive conditions; maternal death.
Interventions
N=522 betamethasone (12 mg IM twice, 24 hours apart).
N=504 placebo (matching placebo).
Primary outcome
Differential Ability Scales-Second Edition General Conceptual Ability score < 85
17.1%
18.5%
18.5 %
13.9 %
9.3 %
4.6 %
0.0 %
Betamethasone
Placebo
No significant
difference ↔
No significant difference in Differential Ability Scales-Second Edition General Conceptual Ability score < 85 (17.1% vs. 18.5%; RR 0.94, 95% CI 0.73 to 1.22).
Secondary outcomes
No significant difference in Differential Ability Scales-Second Edition General Conceptual Ability (13.8% vs. 13.7%).
No significant difference in Social Responsiveness Scale T-score > 65 (13.5% vs. 14.3%; RR 0.92, 95% CI 0.68 to 1.24).
Conclusion
In children, aged ≥ 6 years, born to mothers at high risk of preterm delivery from 34-36 completed weeks, betamethasone was not superior to placebo with respect to Differential Ability Scales-Second Edition General Conceptual Ability score < 85.
Reference
Cynthia Gyamfi-Bannerman, Rebecca G Clifton, Alan T N Tita et al. Neurodevelopmental Outcomes After Late Preterm Antenatal Corticosteroids: The ALPS Follow-Up Study. JAMA. 2024 May 21;331(19):1629-1637.
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