Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial
A multicentred randomised controlled trial of repeat doses of prenatal corticosteroid given to women who remain at risk of preterm delivery for the prevention of neonatal morbidity.
Professor Caroline Crowther
980 participants
Apr 12, 1998
Interventional
Conditions
Summary
Preterm infants are at high risk of respiratory distress syndrome (RDS) as a consequence of immature lung development. RDS is the principle cause of early mortality and contributes significantly to the high costs of neonatal care. Prenatal corticosteroids substantially reduce the risk of RDS in babies born within 7 days of maternal treatment. Hence, in clinical practice, there has been a tendency to repeat the dose after 7 days in women who remain at risk of preterm birth. However, no formal policy exists. This trial seeks to evaluate the beneficial and adverse effects of repeat doses of prenatal steroids as they may provide a simple, inexpensive way to improve health outcomes for preterm infants. Multi-centre, placebo controlled, double-blind trial. All participants, caregivers, researchers and data analyst are blinded until all prespecified analyses completed. The corticosteroid and saline placebo syringes were identically labelled and the contents masked.
Eligibility
Inclusion Criteria1
- Singleton, twin or triplet pregnancy; <32 weeks gestation; > or = 7 days since first corticosteroid treatment, remaining at risk of preterm delivery; informed written signed consent given.
Exclusion Criteria1
- Women with chrioamnionitis requiring urgent delivery; Women in whom L/S ratio or equivalent test is judged mature; Women in 2nd stage labour; Women in whom corticosteroid therapy is considered essential.
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Interventions
Treatment group: A weekly intramuscular injection of celestone chronodose (2mls, 11.4 mgs) while at risk of preterm birth and if less than 32 weeks gestational age
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000318583