Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000412538
Ethics application status
Approved
Date submitted
12/09/2006
Date registered
21/09/2006
Date last updated
21/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving neurobehavioural development in preterm infants
Scientific title
'Environmental intervention, using parent sensitivity training, to improve neurobehavioural development in preterm infants: A randomised controlled trial'.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potential neurobehavioural and neurodevelopmental deficits associated with premature birth 1379 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive parent sensitivity training in first 12 weeks following premature birth aimed at reducing infant stress.
Intervention code [1] 1342 0
Prevention
Comparator / control treatment
Control Group mothers receive one psycho-educational session concerning coping with stress and copies of an educational booklet
Control group
Active

Outcomes
Primary outcome [1] 2035 0
Neurobehavioural development as assessed by the Ages & Stages Questionnaire
Timepoint [1] 2035 0
At 6 and 12 months.
Primary outcome [2] 2036 0
Neurobehavioural development as assessed by the Bayley Scales of Infant Development (III) and the Child Behavior Checklist
Timepoint [2] 2036 0
At 24 months of age.
Primary outcome [3] 2037 0
Neurobehavioural development as assessed by the Short Temperament Scales
Timepoint [3] 2037 0
At 6, 12 and 24 months.
Primary outcome [4] 2038 0
Medical stablility
Timepoint [4] 2038 0
At 40 weeks post-conceptual age.
Primary outcome [5] 2039 0
The Neonatal Medical Index computed from hospital records
Timepoint [5] 2039 0
At date of discharge.
Secondary outcome [1] 3524 0
Timepoint [1] 3524 0

Eligibility
Key inclusion criteria
Mothers of singleton or twin infants born at less than or equal to 30 weeks gestational age will be included.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Families living outside a 100km radius of Melbourne, those with insufficient English, and those whose infants have a congenital abnormality will be excluded. Any mothers whose young age precludes them from giving fully informed consent will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central administration of a coded, blinded, independently pre-generated allocation schedule operated via a sytem of sealed, numbered, opaque, tamper-evident envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Variable-length permuted blocks, computer-generated random sequence, stratified with respect to study site and with respect to twin versus singleton families
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1611 0
Government body
Name [1] 1611 0
NHMRC
Country [1] 1611 0
Australia
Primary sponsor type
Other
Name
Parent-Infant Research Institute, Austin Health, Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1414 0
None
Name [1] 1414 0
none
Address [1] 1414 0
Country [1] 1414 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3055 0
Mercy Hospital for Women
Ethics committee address [1] 3055 0
Ethics committee country [1] 3055 0
Australia
Date submitted for ethics approval [1] 3055 0
Approval date [1] 3055 0
02/06/2006
Ethics approval number [1] 3055 0
R06/01
Ethics committee name [2] 3056 0
Royal Womens Hospital
Ethics committee address [2] 3056 0
Ethics committee country [2] 3056 0
Australia
Date submitted for ethics approval [2] 3056 0
Approval date [2] 3056 0
11/04/2006
Ethics approval number [2] 3056 0
06/03

Summary
Brief summary
To date, intervention foci to improve neurobehavioural outcomes in preterm infants have been primarily medical. The intervention developed for this study is based on the observation of severe dysregulation in premature infants and the potential of sensitive maternal-infant interaction to modulate the damaging effects of stress on infants' general and brain development. In essence we aim to train mothers to be therapists to their own hospitalised preterm infant. The development of infants of intervention and control mothers will be assessed and compared at several ages until 24 months corrected age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27949 0
Address 27949 0
Country 27949 0
Phone 27949 0
Fax 27949 0
Email 27949 0
Contact person for public queries
Name 10531 0
Professor Jeannette Milgrom
Address 10531 0
Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081
Country 10531 0
Australia
Phone 10531 0
+61 03 9496 4496
Fax 10531 0
+61 03 9496 4148
Email 10531 0
[email protected]
Contact person for scientific queries
Name 1459 0
Professor Jeannette Milgrom
Address 1459 0
Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081
Country 1459 0
Australia
Phone 1459 0
+61 03 9496 4496
Fax 1459 0
+61 03 9496 4148
Email 1459 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
EmbaseBehavioural and cognitive outcomes following an early stress-reduction intervention for very preterm and extremely preterm infants.2019https://dx.doi.org/10.1038/s41390-019-0385-9
N.B. These documents automatically identified may not have been verified by the study sponsor.