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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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000318583
Acronym
ACTORDS (Australasian Collaborative Trial of Repeat Doses of Corticosteroids for the Prevention of N
Enrollment
982
Registered
2001-03-05
Start date
1998-04-12
Completion date
2004-07-20
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Sponsors

Professor Caroline Crowther
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
16 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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 criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 22, 2026