Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000394741
Ethics application status
Not yet submitted
Date submitted
8/04/2013
Date registered
10/04/2013
Date last updated
10/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do cost-effectiveness analyses underestimate the benefits of preventing disability in preterm infants? A systematic review
Scientific title
Systematic review of randomised trials and observational studies in preterm infants of interventions to prevent long-term disability
Secondary ID [1] 282268 0
None
Universal Trial Number (UTN)
U1111-1141-6150
Trial acronym
CEAPOD-PTI

Cost effectiveness analyses of prevention of disability in preterm infants
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prematurity 288800 0
disability 288801 0
Condition category
Condition code
Reproductive Health and Childbirth 289158 289158 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 289185 289185 0 0
Complications of newborn
Reproductive Health and Childbirth 289186 289186 0 0
Antenatal care

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Any antenatal, intrapartum or postnatal intervention in pregnancy before 37 weeks gestation or in infants of less than 37 weeks gestation with disability as an outcome.
Intervention code [1] 286898 0
Not applicable
Comparator / control treatment
active treatment or no treatment
Control group
Active

Outcomes
Primary outcome [1] 289266 0
An estimate of one of the following outcomes for the child post initial hospital discharge:

chronic condition/s (i.e. cerebral palsy, deafness, blindness, cognitive impairment); or disability (possibly categorised as mild/moderate/severe) defined according to the tests or instruments adopted in each study; or utility
Timepoint [1] 289266 0
at any time after hospital discharge
Primary outcome [2] 289267 0
cost effectiveness of preventing disability, defined using the tests or instruments adopted in each study
Timepoint [2] 289267 0
projected lifelong for the child and parents
Secondary outcome [1] 302135 0
death
Timepoint [1] 302135 0
at any time after birth

Eligibility
Key inclusion criteria
Any type of clinical study including RCTs, observational studies or a search of the published literature, which included both the costs and consequences of an intervention and its comparator. Studies must include interventions in pregnant women or newborn babies before 28 days after birth. Studies are eligible if published between 1 January 2002 and 31 December 2012
Minimum age
No limit
Maximum age
1 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stillbirths

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
1/02/2012
Date of last participant enrolment
Anticipated
31/12/2012
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 4990 0
United Kingdom
State/province [1] 4990 0
Country [2] 4991 0
United States of America
State/province [2] 4991 0
Country [3] 5000 0
Belgium
State/province [3] 5000 0
Country [4] 5001 0
Netherlands
State/province [4] 5001 0
Country [5] 5002 0
Sweden
State/province [5] 5002 0
Country [6] 5003 0
Canada
State/province [6] 5003 0
Country [7] 5004 0
France
State/province [7] 5004 0
Country [8] 5005 0
Mexico
State/province [8] 5005 0
Country [9] 5006 0
Spain
State/province [9] 5006 0

Funding & Sponsors
Funding source category [1] 287038 0
University
Name [1] 287038 0
NHMRC Clinical Trials Centre, University of Sydney
Country [1] 287038 0
Australia
Primary sponsor type
University
Name
WINNER Centre for Newborn Research, NHMRC CTC University of Sydney
Address
Locked Bag 77
Camperdown
NSW 1450
Country
Australia
Secondary sponsor category [1] 285816 0
University
Name [1] 285816 0
NHMRC Clinical Trials Centre, Univerrsity of Sydney
Address [1] 285816 0
Locked Bag 77
Camperdown NSW 1450
Country [1] 285816 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289072 0
Ethics approval not required for this systematic review
Ethics committee address [1] 289072 0
Ethics committee country [1] 289072 0
Date submitted for ethics approval [1] 289072 0
31/05/2013
Approval date [1] 289072 0
Ethics approval number [1] 289072 0

Summary
Brief summary
More than one in ten infants are born preterm, with increased risk of disability. To guide public policy reliably, cost-effectiveness analyses of interventions to prevent disability require a long-term societal perspective, including costs of hospital treatment, special education, family or community care, and lost parent and child productivity.

Methods: We evaluated (i) the proportion of cost effectiveness analyses with a long-term societal perspective and (ii) whether analyses with a long-term societal perspective were more frequent within randomised controlled trials (RCTs). Original, peer-reviewed research articles in English from 1 January 2002 through 31 December, 2012 were eligible for inclusion in the review if they described cost-effectiveness analyses of interventions before or after preterm birth and reported disability. Searches by two reviewers in The Cochrane Library, EconLit, EMBASE and MEDLINE databases yielded 220 articles. Reference lists from those articles yielded another 5 articles. Of these 225 articles 25 described cost-effectiveness analyses that met the inclusion criteria.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39086 0
Prof William Odita Tarnow-Mordi
Address 39086 0
WINNER Centre for Newborn Research
NHMRC Clinical Trials Centre
University of Sydney

Locked Bag 77
Camperdown
NSW 1450
Country 39086 0
Australia
Phone 39086 0
612 9562 5062
Fax 39086 0
Email 39086 0
williamtm@med.usyd.edu.au
Contact person for public queries
Name 39087 0
Prof Deborah Schofield
Address 39087 0
NHMRC Clinical Trials Centre
University of Sydney

Locked Bag 77
Camperdown
NSW 1450
Country 39087 0
Australia
Phone 39087 0
612 9562 5044
Fax 39087 0
Email 39087 0
deborah.schofield@ctc.usyd.edu.au
Contact person for scientific queries
Name 39088 0
Prof Deborah Schofield
Address 39088 0
NHMRC Clinical Trials Centre
University of Sydney

Locked Bag 77
Camperdown
NSW 1450
Country 39088 0
Australia
Phone 39088 0
612 9562 5044
Fax 39088 0
Email 39088 0
williamtm@med.usyd.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
No additional documents have been identified.