Trial Review

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
ACTRN12605000492651
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
23/09/2005
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Date results information initially provided
17/02/2020
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
2/01/2005
Actual
12/01/2005
Date of last participant enrolment
Anticipated
Actual
17/01/2007
Date of last data collection
Anticipated
Actual
16/09/2015
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 763 0
Government body
Name [1] 763 0
NHMRC
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
01/10/2004
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
Pediatrics 2016; 138:6
Public notes

Contacts
Principal investigator
Name 36229 0
Prof Lex Doyle
Address 36229 0
Department of Obstetrics and Gynaecology The Royal Women's Hospital 132 Grattan St Carlton VIC 3053
Country 36229 0
Australia
Phone 36229 0
+61 3 8345 3716
Fax 36229 0
Email 36229 0
[email protected]
Contact person for public queries
Name 9772 0
Prof 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 8345 3716
Fax 9772 0
+61 3 8345 3702
Email 9772 0
[email protected]
Contact person for scientific queries
Name 700 0
Prof 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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No ethical permission to provide data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Pediatrics 2010;126:e171-e178
Study results articleYes Pediatrics 2012; 130:1094-1101
Study results articleYes Pediatrics 2016; 138: 6 10.1542/peds.2016-1363
Plain language summaryNo This study demonstrated that an early preventive c... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThirteen-Year Outcomes of a Randomized Clinical Trial of Early Preventive Care for Very Preterm Infants and Their Parents.2022https://dx.doi.org/10.1016/j.jpeds.2022.03.013
Dimensions AIImproving the outcome of infants born at <30 weeks' gestation - a randomized controlled trial of preventative care at home2009https://doi.org/10.1186/1471-2431-9-73
N.B. These documents automatically identified may not have been verified by the study sponsor.