Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000318583
Ethics application status
Approved
Date submitted
5/03/2001
Date registered
5/03/2001
Date last updated
11/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial
Scientific title
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.
Secondary ID [1] 24 0
Perinatal Trials Registry: PTR349
Universal Trial Number (UTN)
Trial acronym
ACTORDS (Australasian Collaborative Trial of Repeat Doses of Corticosteroids for the Prevention of Neonatal Respiratory Disease)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Women at risk of preterm birth, at less than 32 weeks gestation, who have already received a course of prenatal corticosteroids. 24 0
Condition category
Condition code
Reproductive Health and Childbirth 26 26 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 27 27 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 1087 0
Treatment: Drugs
Comparator / control treatment
Control Group: A weekly injection of normal saline (2 mls) while at risk of preterm birth and < 32 week gestational age
Control group
Placebo

Outcomes
Primary outcome [1] 53 0
Neonatal lung disease
Timepoint [1] 53 0
Diagnosed in neonatal period up to hospital discharge
Primary outcome [2] 54 0
Weight, length and head circumference
Timepoint [2] 54 0
Measured at birth and primary hospital discharge.
Secondary outcome [1] 77 0
Maternal infection
Timepoint [1] 77 0
Measured in the antenatal, intrapartum and postnatal periods.
Secondary outcome [2] 78 0
Maternal quality of life
Timepoint [2] 78 0
Measured at 6 months post-partum
Secondary outcome [3] 79 0
Other neonatal morbidity
Timepoint [3] 79 0
Diagnosed in neonatal period up to hospital discharge.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

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)
Central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule computer generated with variable block sizes. Treatment allocation stratified by centre, plurality (singleton, twins, triplets), gestational age <28 weeks and >= 28 weeks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/1998
Actual
12/04/1998
Date of last participant enrolment
Anticipated
Actual
20/07/2004
Date of last data collection
Anticipated
Actual
31/12/2011
Sample size
Target
980
Accrual to date
Final
982
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS
Recruitment outside Australia
Country [1] 8565 0
New Zealand
State/province [1] 8565 0

Funding & Sponsors
Funding source category [1] 34 0
Government body
Name [1] 34 0
National Health & Medical Research Council Project Grant
Country [1] 34 0
Australia
Primary sponsor type
Individual
Name
Professor Caroline Crowther
Address
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 31 0
None
Name [1] 31 0
Nil
Address [1] 31 0
Country [1] 31 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286 0
Women's & Children's Hospital, Maternal Perinatal Clinical Trials Unit of The University of Adelaide
Ethics committee address [1] 286 0
Ethics committee country [1] 286 0
Australia
Date submitted for ethics approval [1] 286 0
Approval date [1] 286 0
01/06/1997
Ethics approval number [1] 286 0
REC773/4/20060
Ethics committee name [2] 287 0
Royal North Shore Hospital
Ethics committee address [2] 287 0
Ethics committee country [2] 287 0
Australia
Date submitted for ethics approval [2] 287 0
Approval date [2] 287 0
Ethics approval number [2] 287 0
Ethics committee name [3] 288 0
RPA Women's & Babies
Ethics committee address [3] 288 0
Ethics committee country [3] 288 0
Australia
Date submitted for ethics approval [3] 288 0
Approval date [3] 288 0
Ethics approval number [3] 288 0
Ethics committee name [4] 289 0
Royal Hospital for Women
Ethics committee address [4] 289 0
Ethics committee country [4] 289 0
Australia
Date submitted for ethics approval [4] 289 0
Approval date [4] 289 0
Ethics approval number [4] 289 0
Ethics committee name [5] 290 0
John Hunter Hospital
Ethics committee address [5] 290 0
Ethics committee country [5] 290 0
Australia
Date submitted for ethics approval [5] 290 0
Approval date [5] 290 0
01/09/1998
Ethics approval number [5] 290 0
Ethics committee name [6] 291 0
Royal Women's Hospital
Ethics committee address [6] 291 0
Ethics committee country [6] 291 0
Australia
Date submitted for ethics approval [6] 291 0
Approval date [6] 291 0
01/09/1998
Ethics approval number [6] 291 0
Ethics committee name [7] 292 0
Mercy Hospital for Women
Ethics committee address [7] 292 0
Ethics committee country [7] 292 0
Australia
Date submitted for ethics approval [7] 292 0
Approval date [7] 292 0
01/02/1998
Ethics approval number [7] 292 0
Ethics committee name [8] 293 0
Monash Medical Centre
Ethics committee address [8] 293 0
Ethics committee country [8] 293 0
Australia
Date submitted for ethics approval [8] 293 0
Approval date [8] 293 0
01/07/1998
Ethics approval number [8] 293 0
98062B
Ethics committee name [9] 294 0
Townsville Hospital
Ethics committee address [9] 294 0
Ethics committee country [9] 294 0
Australia
Date submitted for ethics approval [9] 294 0
Approval date [9] 294 0
01/04/1998
Ethics approval number [9] 294 0
3/98
Ethics committee name [10] 295 0
Royal Women's Hospital
Ethics committee address [10] 295 0
Ethics committee country [10] 295 0
Australia
Date submitted for ethics approval [10] 295 0
Approval date [10] 295 0
01/09/1998
Ethics approval number [10] 295 0
Ethics committee name [11] 296 0
Mater Mother's Hospital
Ethics committee address [11] 296 0
Ethics committee country [11] 296 0
Australia
Date submitted for ethics approval [11] 296 0
Approval date [11] 296 0
01/07/1998
Ethics approval number [11] 296 0
Ethics committee name [12] 297 0
Hervey Bay Hospital
Ethics committee address [12] 297 0
Ethics committee country [12] 297 0
Australia
Date submitted for ethics approval [12] 297 0
Approval date [12] 297 0
01/09/1999
Ethics approval number [12] 297 0
Ethics committee name [13] 298 0
Toowoomba Hospital
Ethics committee address [13] 298 0
Ethics committee country [13] 298 0
Australia
Date submitted for ethics approval [13] 298 0
Approval date [13] 298 0
01/10/2000
Ethics approval number [13] 298 0
Ethics committee name [14] 299 0
Royal Hobart Hospital
Ethics committee address [14] 299 0
Ethics committee country [14] 299 0
Australia
Date submitted for ethics approval [14] 299 0
Approval date [14] 299 0
Ethics approval number [14] 299 0
Ethics committee name [15] 300 0
Canberra Hospital
Ethics committee address [15] 300 0
Ethics committee country [15] 300 0
Australia
Date submitted for ethics approval [15] 300 0
Approval date [15] 300 0
01/09/1998
Ethics approval number [15] 300 0
ETH.8/98.222
Ethics committee name [16] 301 0
National Women's Hospital
Ethics committee address [16] 301 0
Ethics committee country [16] 301 0
New Zealand
Date submitted for ethics approval [16] 301 0
Approval date [16] 301 0
01/10/1998
Ethics approval number [16] 301 0
98/09/153
Ethics committee name [17] 302 0
Christchurch Women's Hospital
Ethics committee address [17] 302 0
Ethics committee country [17] 302 0
New Zealand
Date submitted for ethics approval [17] 302 0
Approval date [17] 302 0
Ethics approval number [17] 302 0
Ethics committee name [18] 303 0
Waikato Hospital
Ethics committee address [18] 303 0
Ethics committee country [18] 303 0
New Zealand
Date submitted for ethics approval [18] 303 0
Approval date [18] 303 0
01/04/1998
Ethics approval number [18] 303 0
Ethics committee name [19] 304 0
Dunedin Hospital
Ethics committee address [19] 304 0
Ethics committee country [19] 304 0
New Zealand
Date submitted for ethics approval [19] 304 0
Approval date [19] 304 0
01/11/1998
Ethics approval number [19] 304 0
98/07/051
Ethics committee name [20] 305 0
Middlemore Hospital
Ethics committee address [20] 305 0
Ethics committee country [20] 305 0
New Zealand
Date submitted for ethics approval [20] 305 0
Approval date [20] 305 0
01/06/2001
Ethics approval number [20] 305 0
Ethics committee name [21] 306 0
Wellington Women's Hospital
Ethics committee address [21] 306 0
Ethics committee country [21] 306 0
New Zealand
Date submitted for ethics approval [21] 306 0
Approval date [21] 306 0
Ethics approval number [21] 306 0
01/07/087
Ethics committee name [22] 307 0
Palmerston North Hospital
Ethics committee address [22] 307 0
Ethics committee country [22] 307 0
New Zealand
Date submitted for ethics approval [22] 307 0
Approval date [22] 307 0
Ethics approval number [22] 307 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1357 1357 0 0
/AnzctrAttachments/1336-e20160947.full.pdf (Publication)
Attachments [2] 1358 1358 0 0
/AnzctrAttachments/1336-1-s2.0-S0140673606688466-main.pdf (Publication)
Attachments [3] 1359 1359 0 0
/AnzctrAttachments/1336-nejmoa071152.pdf (Publication)

Contacts
Principal investigator
Name 35436 0
Prof Caroline Crowther
Address 35436 0
Women's & Children's Hospital
72 King William Rd
North Adelaide SA 5006
Country 35436 0
Australia
Phone 35436 0
+61 8 8161 7619
Fax 35436 0
Email 35436 0
carolione.crowther@adelaide.edu.au
Contact person for public queries
Name 10276 0
Caroline Crowther
Address 10276 0
University Obstetrics & Gynaecology
Women's and Children's Hospital
Queen Victoria Building
Level 1
72 King William Road
North Adelaide SA 5006
Country 10276 0
Australia
Phone 10276 0
+61 8 8161 7619
Fax 10276 0
+61 8 8161 7652
Email 10276 0
caroline.crowther@adelaide.edu.au
Contact person for scientific queries
Name 1204 0
Caroline Crowther
Address 1204 0
University Obstetrics & Gynaecology
Women's and Children's Hospital
Queen Victoria Building
Level 1
72 King William Road
North Adelaide SA 5006
Country 1204 0
Australia
Phone 1204 0
+61 8 8161 7619
Fax 1204 0
+61 8 8161 7652
Email 1204 0
caroline.crowther@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMid-childhood bone mass after exposure to repeat doses of antenatal glucocorticoids: A randomized trial.2017https://dx.doi.org/10.1542/peds.2016-4250
N.B. These documents automatically identified may not have been verified by the study sponsor.