Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000430639
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
16/09/2005
Date last updated
16/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A follow-up study of babies with birthweight <2000 gms looking at outcomes and access to appropriate developmental surveillance.
Scientific title
A follow-up study of babies with birthweight <2000 gms looking at outcomes and access to appropriate developmental surveillance.
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low-birthweight, prematurity, nerodevelopmental delay 540 0
Condition category
Condition code
Reproductive Health and Childbirth 619 619 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No specific intervention is being offeredto the study group. It is a retrospective study.
Intervention code [1] 539 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 724 0
To establish whether or not the current process of follow-up is meeting the needs of these children.
Timepoint [1] 724 0
Secondary outcome [1] 1489 0
Hopefully obstacles to accessing developmental surveillance will be better identified. Also those most at risk will be identified.
Timepoint [1] 1489 0

Eligibility
Key inclusion criteria
Birthweiht <2000gms, Cared for at the Launceston, General Hospital Jan 1997- Jun 2000.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those uncontactable, deceased, moved interstate, or unwilling to participate.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 677 0
Charities/Societies/Foundations
Name [1] 677 0
Clifford Craig Medical Reasearh Trust
Country [1] 677 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Research Trust
Address
Country
Australia
Secondary sponsor category [1] 566 0
Hospital
Name [1] 566 0
Women's and Children's Services, LGH
Address [1] 566 0
Country [1] 566 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1857 0
Launceston General Hospital Medical Ethics Committee
Ethics committee address [1] 1857 0
Ethics committee country [1] 1857 0
Australia
Date submitted for ethics approval [1] 1857 0
Approval date [1] 1857 0
Ethics approval number [1] 1857 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35643 0
Address 35643 0
Country 35643 0
Phone 35643 0
Fax 35643 0
Email 35643 0
Contact person for public queries
Name 9728 0
Dr Margaret Phelan
Address 9728 0
Launceston General Hospital
Charles St
Launceston TAS 7250
Country 9728 0
Australia
Phone 9728 0
+61 3 63301145
Fax 9728 0
+61 3 63488973
Email 9728 0
phelanmm@bigpond.com
Contact person for scientific queries
Name 656 0
Dr Margaret Phelan
Address 656 0
197 Bridgenorth
Legana TAS 7277
Country 656 0
Australia
Phone 656 0
+61 3 63301145
Fax 656 0
+61 3 63488973
Email 656 0
phelanmm@bipond.com

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.