Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000472572
Ethics application status
Approved
Date submitted
1/03/2004
Date registered
1/03/2004
Date last updated
18/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising very preterm infant outcomes: an evidence based screening and surveillance method
Scientific title
The accurate identification of very preterm infant disability by general practitioners in the primary practice setting using screening and surveillance methods
Secondary ID [1] 54 0
Perinatal Trials Registry: PTR518
Universal Trial Number (UTN)
Trial acronym
OPIO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability of very preterm infant 50 0
Condition category
Condition code
Reproductive Health and Childbirth 56 56 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children born very preterm-at a gestation less than 31 completed weeks- at approximately two weeks prior to discharge from the special care nurseries of Queensland tertiary maternity hospitals were randomised to either the preterm-targeted screening and surveillance group (which was a targeted screening program for disability) or to the National Health Medical Research Council screening program (which is the Australian routine and universal child health program for disability). Both groups screening programs were cordinated by the child's general practitioner. Screening was conducted over the child's first 12-months corrected age of life. General practitioners used the infomation from their respective programs to complete a questionnaire on disability which they returned to the coordinating centre at the Royal Brisbane Women's Hopsital.
Intervention code [1] 1115 0
Early detection / Screening
Comparator / control treatment
National Health Medical Research Council screening program (which is the Australian routine and universal child health program for disability).
Control group
Active

Outcomes
Primary outcome [1] 88 0
Agreement (agreed status / disagreed and unsure status) on the primary classification of disability status between general practitioners in both groups (preterm-targeted and National Health Medical Research Council) and the tertiary centre neurodevelopmental assessment at 12-months corrected age conducted in the tertiary centre hospital. Status=disabled will be defined by the neurodevelopmental assessment as the presence of any of: crebral palsy where a child has nonprogressive motor impairment characterized by abnormal muscle tone and movement, developmental delay where a child scored more than 1.0 SD below the standardised test mean assessed with the Revised Griffith Mental Development Scales or the Bayley Scales of Infant Development II - Mental Developmental Intelligence, bilateral blindness if visual acuity in both eyes was worse than 6/60 and deaf if they required aids. Clinicians performing the tertiary assessment were blinded to the child’s trial treatment assignation.
Timepoint [1] 88 0
At 12-months corrected age
Secondary outcome [1] 177 0
Sensitivity analysis.
There were three sensitivity analyses. 1) Agreement on a secondary classification of disability status (<-2SD developmental quoitents, cerebral palsy, bilateral blindness or hearing requiring aids) correctly identified by general practitioner in both groups.
The primary classification of disability was used to test the two general practitioner groups for 2) interrater agreement (agreed status / disagreed ststus)and as a 3) screening instrument.
Timepoint [1] 177 0
Secondary outcome [2] 178 0
1. The effect of the screening and surveillance programs on parental stress and parent-child interaction measured by the Edinburgh Postnatal Depression Scale and the Parenting Stress Index-Short Form
Timepoint [2] 178 0
At 12-months corrected age of the child.
Secondary outcome [3] 179 0
2. Families were asked to document the health services they used including rehospitalisations
Timepoint [3] 179 0
Over the 12-month study period.
Secondary outcome [4] 180 0
3. A locally designed questionnaire on how helpful the assigned program was in assisting with child health was sent to parents and general practitioners
Timepoint [4] 180 0
At completion of the study at 12-months corrected age of the child.

Eligibility
Key inclusion criteria
Infants who met the following criteria were enrolled two weeks prior to discharge from the special care nursery by research assistants from each of Queensland's three tertiary maternity hospitals (The Royal Brisbane Women's Hosiptal RBWH, Mater Mother's Hospital MMH, The Townsville Hospital TTH):Inclusion criteria included: infants (male and female) born at a gestation less than 31 completed weeks, whose family could nominate a general practioner and who would return for follow.
Minimum age
Not stated
Maximum age
31 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose of the study
Diagnosis
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)
Block randomisation with random even-numbers between ten and twenty inclusively, stratified for hospital, gestation and social risk factors (two or more of the following: indigenous, single parent, maternal education below school grade 10 or gross weekly household income less than $400.00) were used to assign infants to treatment groups. The first child of a multiple birth was randomised and its siblings automatically assigned to the same group through a central telephone randomisation service. The study investigators were unaware of the block sizes employed and had no access to either the computer or randomisation database.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/12/2002
Actual
11/12/2002
Date of last participant enrolment
Anticipated
Actual
20/08/2004
Date of last data collection
Anticipated
Actual
20/08/2005
Sample size
Target
202
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 80 0
Government body
Name [1] 80 0
Queensland Health Golden Carsket
Country [1] 80 0
Australia
Funding source category [2] 81 0
Charities/Societies/Foundations
Name [2] 81 0
Bonnie Babes
Country [2] 81 0
Australia
Funding source category [3] 82 0
Hospital
Name [3] 82 0
Royal Brisbane Women's Hospital Research Scholarship
Country [3] 82 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 66 0
Government body
Name [1] 66 0
Queensland Health
Address [1] 66 0
Country [1] 66 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 585 0
Royal Brisbane Women's Hospital
Ethics committee address [1] 585 0
Ethics committee country [1] 585 0
Australia
Date submitted for ethics approval [1] 585 0
15/08/2002
Approval date [1] 585 0
13/11/2002
Ethics approval number [1] 585 0
RBWH02/16
Ethics committee name [2] 586 0
University of Queensland
Ethics committee address [2] 586 0
Ethics committee country [2] 586 0
Australia
Date submitted for ethics approval [2] 586 0
Approval date [2] 586 0
Ethics approval number [2] 586 0
2002000895
Ethics committee name [3] 587 0
The Townsville Hospital
Ethics committee address [3] 587 0
Ethics committee country [3] 587 0
Australia
Date submitted for ethics approval [3] 587 0
Approval date [3] 587 0
17/11/2002
Ethics approval number [3] 587 0
40/02
Ethics committee name [4] 588 0
Mater Mothers' Hospital
Ethics committee address [4] 588 0
Ethics committee country [4] 588 0
Australia
Date submitted for ethics approval [4] 588 0
12/09/2002
Approval date [4] 588 0
13/11/2002
Ethics approval number [4] 588 0
540M

Summary
Brief summary
Studies in the United Kingdom have shown the feasibility of collecting a standardised core of data with specific criteria for defining disability in children born very preterm at two years of age from questionnaires completed by parents and health care clinicians. Evaluation of outcomes for children born very preterm by questionnaires are very important for the purpose of providing global and epidemiologic information on outcomes, and for planning of services. However, most of the available questionnaires are a subjective assessment of the child and liable to bias. We are proposing the use of questionnaires to collect late morbidity and disability data from the primary health sector in children born very preterm with the support of a structured preterm clinical pathway for screening and surveillance. The pathway has been designed to ensure standardised data collection providing a more objective and valid assessment of late morbidity and disability. It is not designed to replace specialist assessment of a child.
Trial website
Trial related presentations / publications
Pritchard MA, Colditz PB, Beller EM, Tudehope D, Gray P, Cartwright D, Wigg N. A preterm-targeted screening program for measuring sensorineural status in a primary health setting: A randomised controlled trial. J Paediatr and Child Health 2008 44 424-431
Public notes

Contacts
Principal investigator
Name 36324 0
Address 36324 0
Country 36324 0
Phone 36324 0
Fax 36324 0
Email 36324 0
Contact person for public queries
Name 10304 0
Margo Anne Pritchard
Address 10304 0
Perinatal Research Centre
Level 6
Ned Hanlon Building
University of Queensland
The Royal Brisbane Women's Hospital
Herston QLD 4209
Country 10304 0
Australia
Phone 10304 0
+61 7 36365172
Fax 10304 0
+61 7 36367169
Email 10304 0
[email protected]
Contact person for scientific queries
Name 1232 0
Margo Anne Pritchard
Address 1232 0
Perinatal Research Centre. University of Queensland. Ned Hanlon Building Level 6. The Royal Brisbane Women's Hospital. Herston QLD 4209
Country 1232 0
Australia
Phone 1232 0
+61 7 36365172
Fax 1232 0
+61 7 36367169
Email 1232 0
[email protected]

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
EmbaseMeasuring sensorineural disability in preterm children using a public health screening strategy: A randomised controlled trial.2008https://dx.doi.org/10.1111/j.1440-1754.2008.01323.x
N.B. These documents automatically identified may not have been verified by the study sponsor.