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Trial registered on ANZCTR


Registration number
ACTRN12605000492651
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
11/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE EFFECT OF PRETERM BIRTH ON OUTCOME - A RANDOMISED TRIAL OF PREVENTATIVE CARE
Scientific title
A RANDOMISED TRIAL OF PREVENTATIVE CARE AT HOME IN VERY PRETERM INFANTS ON NEUROSENSORY OUTCOME AT 2 YEARS OF AGE
Universal Trial Number (UTN)
Trial acronym
Vibes plus
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SURVIVING VERY PRETERM INFANTS(<30 WEEKS' GESTATIONAL AGE) 614 0
Condition category
Condition code
Reproductive Health and Childbirth 687 687 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Developmental care administered in the home to surviving infants born < 30 weeks' gestational age by a physiotherapist and a psychologist over the first year of life.
Intervention code [1] 583 0
Treatment: Other
Comparator / control treatment
standard follow-up to 2 years of age
Control group
Active

Outcomes
Primary outcome [1] 838 0
Developmental quotient at 2 years of age
Timepoint [1] 838 0
At 2 years of age
Secondary outcome [1] 1655 0
Neurosensory disability
Timepoint [1] 1655 0
At 2 years of age.
Secondary outcome [2] 1656 0
Motor and cognitive development
Timepoint [2] 1656 0
At 2 years of age.
Secondary outcome [3] 1657 0
Behavioural and emotional functioning
Timepoint [3] 1657 0
At 2 years of age.
Secondary outcome [4] 1658 0
Communication skills
Timepoint [4] 1658 0
At 2 years of age.
Secondary outcome [5] 1659 0
Mother-child interactions
Timepoint [5] 1659 0
At 2 years of age.

Eligibility
Key inclusion criteria
Surviving infants < 30 weeks' gestational age at birth.
Minimum age
0 Days
Maximum age
30 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recognisable congenital anomaly or chromosomal disorder universally associated with adverse developmental outcome.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated independently of chief investigators
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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)

Funding & Sponsors
Funding source category [1] 763 0
Government body
Name [1] 763 0
NHMRC
Address [1] 763 0
Canberra
Country [1] 763 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital, Melbourne
Address
132 Grattan St, Carlton 3053
Country
Australia
Secondary sponsor category [1] 629 0
Hospital
Name [1] 629 0
Royal Children's Hospital, Melbourne
Address [1] 629 0
Flemington Rd, Parkville 3052
Country [1] 629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2008 0
Royal Women's Hospital, Melbourne
Ethics committee address [1] 2008 0
Ethics committee country [1] 2008 0
Australia
Date submitted for ethics approval [1] 2008 0
Approval date [1] 2008 0
Ethics approval number [1] 2008 0
Ethics committee name [2] 2009 0
Royal Children's Hospital Melbourne
Ethics committee address [2] 2009 0
Ethics committee country [2] 2009 0
Australia
Date submitted for ethics approval [2] 2009 0
Approval date [2] 2009 0
Ethics approval number [2] 2009 0

Summary
Brief summary
Surviving infants < 30 weeks' gestational age will be randomly alloacted to a developmental care package delivered in the home or to standard follow-up care over the first year of life. The major endpoint is the Mental Developmental Index on the Bayley Scales of Infant Devlopment at 2 years of age, corrected for prematurity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36229 0
Address 36229 0
Country 36229 0
Phone 36229 0
Fax 36229 0
Email 36229 0
Contact person for public queries
Name 9772 0
Professor Lex Doyle
Address 9772 0
Department of Obstetrics and Gynaecology
The Royal Women's Hospital
132 Grattan St
Carlton VIC 3053
Country 9772 0
Australia
Phone 9772 0
+61 3 93442151
Fax 9772 0
+61 3 93471761
Email 9772 0
lwd@unimelb.edu.au
Contact person for scientific queries
Name 700 0
Professor Lex Doyle
Address 700 0
Department of Obstetrics and Gynaecology
The Royal Women's Hospital
132 Grattan St
Carlton VIC 3053
Country 700 0
Australia
Phone 700 0
+61 3 93442151
Fax 700 0
+61 3 93471761
Email 700 0
lwd@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 391 0
Pediatrics 2010;126:e171-e178
Attachments [1] 391 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
This study demonstrated that an early preventive care program for very preterm infants (<30 weeks of gestation) and their families improved infants’ behavioral outcomes and reduced primary caregivers’ anxiety and depression at corrected age of 2 .