CompletedPhase 3ACTRN12606000318583

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.


Sponsor

Professor Caroline Crowther

Enrollment

980 participants

Start Date

Apr 12, 1998

Study Type

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

Sex: FemalesMin Age: 16 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a repeat course of steroid injections (corticosteroids) to pregnant women at risk of very early delivery can reduce breathing problems in their newborn babies. It is for women aged 16-50 carrying one to three babies who are less than 32 weeks pregnant and received their first steroid course at least 7 days earlier.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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)

New Zealand

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ACTRN12606000318583