Australasian Collaborative Trial of repeat doses of corticosteroids for the prevention of neonate respiratory disease

ISRCTN	ISRCTN48656428
DOI	https://doi.org/10.1186/ISRCTN48656428
Protocol serial number	N/A
Sponsor	The University of Adelaide (Australia)
Funder	National Health and Medical Research Council Project (Australia) (ref: 980185)

Submission date: 18/03/2005
Registration date: 17/06/2005
Last edited: 04/06/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Caroline Crowther
Scientific

University of Adelaide
Womens and Childrens Hospital
72 King William Road
North Adelaide
5006
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Australasian Collaborative Trial of repeat doses of corticosteroids for the prevention of neonate respiratory disease
Study acronym	ACTORDS
Study objectives	Primary hypotheses: Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation: 1. Reduces the risk of neonatal lung disease 2. Adversely affects fetal and neonatal measures of growth Secondary hypothesis: Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation increases the risk of maternal infection
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Neonate respiratory distress syndrome
Intervention	11.4 mg Celestone Chronodose or saline placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Celestone Chronodose
Primary outcome measure(s)	Neonatal respiratory outcomes: 1. Birthweight 2. Length and head circumference at birth 3. Primary discharge from hospital
Key secondary outcome measure(s)	On the mother: 1. Clinical chorioamnionitis requiring intrapartum antibiotics, maternal postpartum pyrexia greater than 38.0°C 2. Other measures of morbidity On the infant: Other measures of foetal and neonatal morbidity.
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Total final enrolment	982
Key inclusion criteria	1. Women with a singleton, twin or triplet pregnancy 2. Gestational age less than 32 weeks who have received initial treatment of corticosteroid seven or more days ago 3. Responsible clinician considers her to be at continued risk of preterm birth 4. Informed, written signed consent 5. No contraindication to further corticosteroid therapy
Key exclusion criteria	1. Women with chorioamnionitis requiring urgent delivery 2. Women in whom the L/S ratio or equivalent test, if determined, is judged to be mature 3. Women who are in the second stage of labour 4. Women in whom corticosteroid therapy is considered essential 5. No contraindication to further corticosteroid therapy
Date of first enrolment	01/01/1998
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

Australia

Study participating centre

University of Adelaide

North Adelaide
5006
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		10/06/2006		Yes	No
Results article	Twenty-year outcomes	28/05/2025	04/06/2025	Yes	No
Other publications	Outcomes in children at 2 years	20/09/2007		Yes	No
Other publications	Cardiovascular risk factors in children at 8 years		27/10/2022	Yes	No

Editorial Notes

04/06/2025: Publication reference added.
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the 2006 reference.