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Trial registered on ANZCTR
Registration number
ACTRN12614000480684
Ethics application status
Approved
Date submitted
20/01/2014
Date registered
9/05/2014
Date last updated
4/09/2020
Date data sharing statement initially provided
4/09/2020
Date results information initially provided
4/09/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Prediction of mild developmental delay and typical outcome in at risk preterm infants.
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Scientific title
In very preterm and very low birth weight infants, will neurological, neurobehavioural, motor and perceptual assessment completed by 16 weeks post term, allow accurate prediction of typical development and mild developmental delay at 2 years corrected age?
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Secondary ID [1]
282918
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Nil known
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Universal Trial Number (UTN)
U1111-1148-0896
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Trial acronym
PREMTiME
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infants born at less than 1500g or 32 weeks gestation with increased risk for neurodevelopmental delay.
289732
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Condition category
Condition code
Reproductive Health and Childbirth
290472
290472
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0
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Complications of newborn
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Early assessment measures:
1. For Infants;
Premie- Neuro Asssessment at 34-35 weeks
General Movement Assessment at 34-35 weeks and 2,5,11-12 and 16 weeks corrected age
Infant Sensory Profile2 at 16 weeks corrected age
Alberta Infant Motor Scale at 16 weeks corrected age
NICU Network Neurobehavioural Scale at 2 or 5 weeks corrected age
2. For Parents;
Edinburgh Post Natal Depression Scale at 34-35 weeks
Social Risk Index at 34-35 weeks
Impact on Families Scale at 34-35 weeks
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Intervention code [1]
287616
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Not applicable
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Comparator / control treatment
NA - This is an observational study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
290496
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Bayley III scores on the Cognitive, Language, Motor and Social-Emotional Scales. Scores on the Adaptive Behaviour Assessment System III
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Assessment method [1]
290496
0
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Timepoint [1]
290496
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2 years corrected age
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Primary outcome [2]
290497
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Motor classification on the Neuro-sensory and Motor Developmental Assessment
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Assessment method [2]
290497
0
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Timepoint [2]
290497
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2 years corrected age
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Primary outcome [3]
290498
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Scores on the Toddler Sensory Profile 2,
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Assessment method [3]
290498
0
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Timepoint [3]
290498
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2 years corrected age
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Secondary outcome [1]
304927
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Scores on the Edinburgh Post Natal Depression Scale
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Assessment method [1]
304927
0
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Timepoint [1]
304927
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5 weeks corrected age
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Secondary outcome [2]
306906
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Scores on the Infant Toddler Social-Emotional Assessment
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Assessment method [2]
306906
0
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Timepoint [2]
306906
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2 years corrected age
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Eligibility
Key inclusion criteria
Infants born at less than 1500g or less than 32 weeks gestation who are admitted to the the Special Care Nursery at Nambour Hospital, the Sunshine Coast University Hospital and the Buderim Private Hospital
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Minimum age
No limit
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Maximum age
37
Weeks
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Infants with major congenital or chromosomal abnormalities
Families living outside a 100km radius from the Nambour General Hospital
Families where no English is spoken
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
2/06/2014
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Actual
19/08/2014
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Date of last participant enrolment
Anticipated
30/12/2016
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Actual
30/11/2018
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Date of last data collection
Anticipated
1/12/2020
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Actual
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Sample size
Target
104
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
1525
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Nambour General Hospital - Nambour
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Recruitment hospital [2]
17435
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [3]
17436
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The Sunshine Coast Private Hospital - Buderim
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Recruitment postcode(s) [1]
7363
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4560 - Nambour
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Recruitment postcode(s) [2]
31164
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4575 - Birtinya
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Recruitment postcode(s) [3]
31165
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4556 - Buderim
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Funding & Sponsors
Funding source category [1]
287973
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Government body
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Name [1]
287973
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Health Practitioner Research Grant,
Allied Health Professions' Office of Queensland, Health Service and Clinical Innovation Division, Department of Health.
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Address [1]
287973
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Allied Health Professions'
Office of Queensland
GPO Box 48
Brisbane QLD 4001
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Country [1]
287973
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Australia
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Funding source category [2]
306658
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Charities/Societies/Foundations
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Name [2]
306658
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Wishlist Sunshine Coast Health Foundation
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Address [2]
306658
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Sunshine Coast University Hospital
6 Doherty Street
Birtinya QLD 4575
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Country [2]
306658
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Australia
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Primary sponsor type
Individual
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Name
Mrs Rebecca Caesar
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Address
Allied Health Paediatrics
Sunshine Coast University Hospital
Reply Paid
PO Box 5340
Sunshine Coast M.C QLD 4560
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Country
Australia
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Secondary sponsor category [1]
286693
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Individual
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Name [1]
286693
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Professor Roslyn Boyd
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Address [1]
286693
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Queensland Cerebral Palsy and Rehabilitation Research Centre
7th Floor, Block 6
Royal Brisbane and Women's Hospital
Herston, QLD 4029
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Country [1]
286693
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289900
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The Children’s Health Queensland Human Research Ethics Commitee (HREC)
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Ethics committee address [1]
289900
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Human Research Ethics Committee
Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
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Ethics committee country [1]
289900
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Australia
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Date submitted for ethics approval [1]
289900
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Approval date [1]
289900
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27/05/2013
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Ethics approval number [1]
289900
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HREC/13/QRCH/66
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Summary
Brief summary
The risk of developmental delay in the preterm population increases as gestational age decreases. As milder delays often go undetected, the challenge in premature infant follow up is early detection without over servicing.
The primary aim of this study is to determine if early clinical assessment completed by 16 weeks post term will allow robust prediction of typical development and mild developmental delay at 2 years corrected age. Earlier prediction will enable clinicians to safely plan discharge for low risk infants from follow up services and facilitate the prioritisation of resources towards infants identified as likely to have mild to moderate or more severe outcomes.
As developmental progress is dependent upon many variables, a combination of clinical tools including neurological assessment, motor assessment and parent questionnaires will be used to predict outcome at 2 years. Likewise a comprehensive selection of outcome measures will be used at 2 years to enable identification of subtle delays. Early findings will be compared to development at 2 years corrected age to determine any predictive relationship for typical outcomes and mild developmental delay.
As families, clinicians and health services continue to want and need more immediate information regarding the short and long term outcomes of preterm infants, finding the best clinical biomarkers has the potential to streamline and effectively prioritise premature infant follow up programs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
41810
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Mrs Rebecca Caesar
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Address
41810
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Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560
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Country
41810
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Australia
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Phone
41810
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+61 7 5202 7493
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Fax
41810
0
+61 7 5202 2688
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Email
41810
0
[email protected]
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Contact person for public queries
Name
41811
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Mrs Rebecca Caesar
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Address
41811
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Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560
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Country
41811
0
Australia
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Phone
41811
0
+61 7 5202 7493
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Fax
41811
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+61 7 5202 2688
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Email
41811
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[email protected]
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Contact person for scientific queries
Name
41812
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Prof Roslyn Boyd
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Address
41812
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Rm 611, level 6, Children's Health Research Centre,
62 Graham Street, South Brisbane, 4010. Queensland. Australia
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Country
41812
0
Australia
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Phone
41812
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+61 7 3069 7372
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Fax
41812
0
no fax number
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Email
41812
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
9060
Study protocol
Caesar R, Boyd RN, Colditz P, et al. Early prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: a study protocol. BMJ Open 2016;6:e010726. doi:10.1136/bmjopen-2015- 010726
9061
Statistical analysis plan
Caesar R, Boyd RN, Colditz P, et al. Early prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: a study protocol. BMJ Open 2016;6:e010726. doi:10.1136/bmjopen-2015- 010726
9062
Ethical approval
364688-(Uploaded-10-04-2020-13-58-36)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Early prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: A study protocol.
2016
https://dx.doi.org/10.1136/bmjopen-2015-010726
N.B. These documents automatically identified may not have been verified by the study sponsor.
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