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Trial registered on ANZCTR


Registration number
ACTRN12608000631303
Ethics application status
Approved
Date submitted
12/11/2008
Date registered
12/12/2008
Date last updated
10/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian Antenatal Study To Evaluate the Role Of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability – a randomised controlled trial
Scientific title
Australasian Antenatal Study To Evaluate the Role Of Intramuscular Dexamethasone versus Betamethasone prior to preterm birth to increase survival free of childhood neurosensory disability – a randomised controlled trial
Secondary ID [1] 279947 0
Nil
Universal Trial Number (UTN)
Trial acronym
A*STEROID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term childhood neurosensory disability following antenatal corticosteroids given to women at risk of preterm birth at less than 34 weeks gestatation 3964 0
Condition category
Condition code
Reproductive Health and Childbirth 4160 4160 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dexamethasone (antenatal corticosteroid) - 2 syringes of 12 mg dexamethasone (dexamethasone sodium phosphate - a non-sulphite containing preparation) administered as 2 intramuscular injections, 24 hours apart.
Intervention code [1] 3683 0
Treatment: Drugs
Comparator / control treatment
Betamethasone (antenatal corticosteroid) - 2 syringes of 11.4 mg betamethasone (as Celestone Chronodose 11.4 mg) administered as 2 intramuscular injections, 24 hours apart.
Control group
Active

Outcomes
Primary outcome [1] 4952 0
Composite of incidence of death (defined as stillbirths, deaths from live born infants before hospital discharge and deaths after hospital discharge) or any neurosensory disability in the children (includes the neurosensory impairments of cerebral palsy, blindness, deafness and any developmental delay defined as a standardised score more than 1 SD below the mean (<-1SD)).
Timepoint [1] 4952 0
At 2 years' corrected age.
Secondary outcome [1] 8349 0
Composite of incidence of death or major neurosensory disability in the children (with major neurosensory disability defined as severe and moderate disability and includes blindness, deafness, cerebral palsy in a child non-ambulant by 2 years of age or a standardised score <-2SD).
Timepoint [1] 8349 0
At 2 years' corrected age.
Secondary outcome [2] 8350 0
Individual components and severity of the primary outcome (cerebral palsy, blindness, deafness, developmental delay).
Timepoint [2] 8350 0
At 2 years' corrected age
Secondary outcome [3] 8351 0
Neonatal outcomes including intraventricular haemorrahge (IVH), severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), retinopathy of prematurity needing treatment, patent ductus arteriosus needing treatment, use of inotropes, respiratory distress syndrome, severity of any neonatal lung disease, chronic lung disease (need for oxygen at 36 weeks post-menstrual age), use of mechanical ventilation, confirmed infection within the first 48 hours, infection after the first 48 hours, body size at birth (weight, length and head circumference) and at discharge home after birth
Timepoint [3] 8351 0
At primary hospital discharge
Secondary outcome [4] 8352 0
Childhood outcomes: developmental domains as measured by Ages & Stages Questionnaire (Bricker & Squires 1999)
Timepoint [4] 8352 0
At 1 year corrected age
Secondary outcome [5] 8353 0
Childhood outcomes: Body size and corresponding Z scores, General health of the child (including use of health services since primary hospitalisation), Childhood respiratory morbidity, Blood pressure Z scores and proportions in hypertensive ranges and Behaviour
Timepoint [5] 8353 0
At 2 years corrected age
Secondary outcome [6] 8354 0
Maternal perinatal infectious morbidity (defined as clinical chorioamnionitis requiring intrapartum antibiotics, use of postpartum antibiotics).
Timepoint [6] 8354 0
Up to 6 weeks post hospital discharge

Eligibility
Key inclusion criteria
Women are eligible for the trial if they are at risk of preterm birth at less than 34 weeks gestation, have a singleton or twin pregnancy, have no contraindications to the use of antenatal corticosteroids and give informed consent.
Minimum age
13 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women are not eligible if they have chorioamnionitis requiring urgent delivery, a higher order multiple pregnancy, have already received antenatal corticosteroids, have known fetal lung maturation, or are in the second stage of labour.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible women are counselled and must give signed, informed consent. Trial entry details are given and eligibility is confirmed, the woman is randomised by contacting the central telephone randomisation service at the University of Adelaide. Assignment to one of two treatment groups: either the dexamethasone group or the betamethasone group. A Study Number and a corresponding numbered treatment pack will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will use balanced variable blocks and will be created using computer software (i.e., computerised sequence generation) by researchers not involved in clinical care. Assignment to either group will be stratified for collaborating centre, gestational age (<28 weeks, >= 28 weeks gestation), and number of fetuses (1 or 2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS
Recruitment outside Australia
Country [1] 1250 0
New Zealand
State/province [1] 1250 0

Funding & Sponsors
Funding source category [1] 4037 0
Government body
Name [1] 4037 0
National Health and Medical Research Council (NHMRC)
Address [1] 4037 0
Physical address:
Level 5, 20 Allara Street
Canberra ACT 2601

Postal address:
GPO Box 1421
Canberra ACT 2601
Country [1] 4037 0
Australia
Primary sponsor type
Hospital
Name
Women’s and Children’s Hospital, SA
Address
72 King William Road,
North Adelaide
SA , 5006
Country
Australia
Secondary sponsor category [1] 3630 0
None
Name [1] 3630 0
Address [1] 3630 0
Country [1] 3630 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6122 0
Children, Youth & Women's Health Service (CYWHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 6122 0
Women's and Children's Hospital,
72 King William Road,
North Adelaide
SA
5006
Ethics committee country [1] 6122 0
Australia
Date submitted for ethics approval [1] 6122 0
Approval date [1] 6122 0
20/10/2008
Ethics approval number [1] 6122 0
REC2074/7/11

Summary
Brief summary
The primary aim of this randomised controlled trial is to determine whether giving antenatal dexamethasone to women at risk of preterm birth at less than 34 weeks gestation increases the chance of their children surviving free of
neurosensory disability at 2 years’ corrected age, compared with women given antenatal betamethasone.
The primary hypothesis of the study is that, compared with betamethasone, antenatal dexamethasone given to women
at risk of preterm birth (less than 34 weeks gestation) reduces the risk of death or any neurosensory disability, caused
by impairments such as cerebral palsy, blindness, deafness or developmental delay, in their children at 2 years’
corrected age.
Specific aims are to assess whether dexamethasone has greater short-term benefits than betamethasone (a greater reduction in the risk of intraventricular haemorrhage as suggested by a new systematic review) and whether there are longer-term effects on childhood neurological function, including motor function, cognition and behaviour, as well as body size, blood pressure and general health.
Trial website
http://www.adelaide.edu.au/arch/research/clinical_trials/asteroid.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29015 0
Prof Caroline Crowther
Address 29015 0
University of Adelaide Obstetrics & Gynaecology
Level 1, Queen Victoria Building
Women's and Children's Hospital
72 King William St
North Adelaide SA 5006
Country 29015 0
Australia
Phone 29015 0
+61 8 8161 7619
Fax 29015 0
Email 29015 0
caroline.crowther@adelaide.edu.au
Contact person for public queries
Name 12172 0
Ms Ms Pat Ashwood
Address 12172 0
Australian Research Centre for Health of Women and Babies (ARCH)
Discipline of Obstetrics and Gynaecology
The University of Adelaide
Women's and Children's Hospital
King William Road
North Adelaide
South Australia 5006
Country 12172 0
Australia
Phone 12172 0
+61 8 8161 7767
Fax 12172 0
+61 8 8161 7652
Email 12172 0
pat.ashwood@adelaide.edu.au
Contact person for scientific queries
Name 3100 0
Prof Professor Caroline Crowther
Address 3100 0
University of Adelaide
Obstetrics & Gynaecology
Level 1, Queen Victoria Building
Women's and Children's Hospital
72 King William St
North Adelaide
SA
5006
Country 3100 0
Australia
Phone 3100 0
+61 8 8161 7647
Fax 3100 0
+61 8 8161 7652
Email 3100 0
caroline.crowther@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary