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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12606000412538 |
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Date of registration:
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21/09/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Improving neurobehavioural development in preterm infants
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Scientific title:
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'Environmental intervention, using parent sensitivity training, to improve neurobehavioural development in preterm infants: A randomised controlled trial'. |
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Date of first enrolment:
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01/10/2006 |
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Target sample size:
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160 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12606000412538.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Countries of recruitment
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Australia
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Contacts
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Name:
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Professor Jeannette Milgrom
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Address:
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Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081
Australia |
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Telephone:
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+61 03 9496 4496 |
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Email:
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jeannette.milgrom@austin.org.au |
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Affiliation:
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Name:
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Professor Jeannette Milgrom
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Address:
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Parent-Infant Research Institute (PIRI)
Department of Clinical & Health Psychology
Heidelberg Repatriation Hospital,
Austin Health,
300 Waterdale Road
Heidelberg West
VIC 3081
Australia |
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Telephone:
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+61 03 9496 4496 |
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Email:
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jeannette.milgrom@austin.org.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Mothers of singleton or twin infants born at less than or equal to 30 weeks gestational age will be included.
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.
Age minimum:
Not stated
Age maximum:
Not stated
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Potential neurobehavioural and neurodevelopmental deficits associated with premature birth;
Potential neurobehavioural and neurodevelopmental deficits associated with premature birth
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Intervention(s)
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Intensive parent sensitivity training in first 12 weeks following premature birth aimed at reducing infant stress.
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Primary Outcome(s)
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Neurobehavioural development as assessed by the Bayley Scales of Infant Development (III) and the Child Behavior Checklist[At 24 months of age.]
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The Neonatal Medical Index computed from hospital records[At date of discharge.]
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Medical stablility[At 40 weeks post-conceptual age.]
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Neurobehavioural development as assessed by the Ages & Stages Questionnaire[At 6 and 12 months.]
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Neurobehavioural development as assessed by the Short Temperament Scales[At 6, 12 and 24 months.]
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Source(s) of Monetary Support
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NHMRC
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Ethics review
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Status: Approved
Approval date:
Contact:
Mercy Hospital for Women
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Status: Approved
Approval date:
Contact:
Royal Womens Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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