Trial Review

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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Prediction of mild developmental delay and typical outcome in at risk preterm infants.
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?
Secondary ID [1] 282918 0
Nil known
Universal Trial Number (UTN)
U1111-1148-0896
Trial acronym
PREMTiME
Linked study record

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 0
Condition category
Condition code
Reproductive Health and Childbirth 290472 290472 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 287616 0
Not applicable
Comparator / control treatment
NA - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290496 0
Bayley III scores on the Cognitive, Language, Motor and Social-Emotional Scales. Scores on the Adaptive Behaviour Assessment System III
Timepoint [1] 290496 0
2 years corrected age
Primary outcome [2] 290497 0
Motor classification on the Neuro-sensory and Motor Developmental Assessment
Timepoint [2] 290497 0
2 years corrected age
Primary outcome [3] 290498 0
Scores on the Toddler Sensory Profile 2,
Timepoint [3] 290498 0
2 years corrected age
Secondary outcome [1] 304927 0
Scores on the Edinburgh Post Natal Depression Scale
Timepoint [1] 304927 0
5 weeks corrected age
Secondary outcome [2] 306906 0
Scores on the Infant Toddler Social-Emotional Assessment
Timepoint [2] 306906 0
2 years corrected age

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
Minimum age
No limit
Maximum age
37 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/06/2014
Actual
19/08/2014
Date of last participant enrolment
Anticipated
30/12/2016
Actual
30/11/2018
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
104
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1525 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 17435 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 17436 0
The Sunshine Coast Private Hospital - Buderim
Recruitment postcode(s) [1] 7363 0
4560 - Nambour
Recruitment postcode(s) [2] 31164 0
4575 - Birtinya
Recruitment postcode(s) [3] 31165 0
4556 - Buderim

Funding & Sponsors
Funding source category [1] 287973 0
Government body
Name [1] 287973 0
Health Practitioner Research Grant,
Allied Health Professions' Office of Queensland, Health Service and Clinical Innovation Division, Department of Health.
Country [1] 287973 0
Australia
Funding source category [2] 306658 0
Charities/Societies/Foundations
Name [2] 306658 0
Wishlist Sunshine Coast Health Foundation
Country [2] 306658 0
Australia
Primary sponsor type
Individual
Name
Mrs Rebecca Caesar
Address
Allied Health Paediatrics
Sunshine Coast University Hospital
Reply Paid
PO Box 5340
Sunshine Coast M.C QLD 4560
Country
Australia
Secondary sponsor category [1] 286693 0
Individual
Name [1] 286693 0
Professor Roslyn Boyd
Address [1] 286693 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
7th Floor, Block 6
Royal Brisbane and Women's Hospital
Herston, QLD 4029
Country [1] 286693 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289900 0
The Children’s Health Queensland Human Research Ethics Commitee (HREC)
Ethics committee address [1] 289900 0
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
Ethics committee country [1] 289900 0
Australia
Date submitted for ethics approval [1] 289900 0
Approval date [1] 289900 0
27/05/2013
Ethics approval number [1] 289900 0
HREC/13/QRCH/66

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41810 0
Mrs Rebecca Caesar
Address 41810 0
Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560
Country 41810 0
Australia
Phone 41810 0
+61 7 5202 7493
Fax 41810 0
+61 7 5202 2688
Email 41810 0
[email protected]
Contact person for public queries
Name 41811 0
Rebecca Caesar
Address 41811 0
Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560
Country 41811 0
Australia
Phone 41811 0
+61 7 5202 7493
Fax 41811 0
+61 7 5202 2688
Email 41811 0
[email protected]
Contact person for scientific queries
Name 41812 0
Roslyn Boyd
Address 41812 0
Rm 611, level 6, Children's Health Research Centre,
62 Graham Street, South Brisbane, 4010. Queensland. Australia
Country 41812 0
Australia
Phone 41812 0
+61 7 3069 7372
Fax 41812 0
no fax number
Email 41812 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9060Study protocolCaesar 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  
9061Statistical analysis planCaesar 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  
9062Ethical 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
SourceTitleYear of PublicationDOI
EmbaseEarly prediction of typical outcome and mild developmental delay for prioritisation of service delivery for very preterm and very low birthweight infants: A study protocol.2016https://dx.doi.org/10.1136/bmjopen-2015-010726
N.B. These documents automatically identified may not have been verified by the study sponsor.