ANZCTR - Registration

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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]

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.

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

NA - This is an observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Bayley III scores on the Cognitive, Language, Motor and Social-Emotional Scales. Scores on the Adaptive Behaviour Assessment System III

Timepoint [1]

2 years corrected age

Primary outcome [2]

Motor classification on the Neuro-sensory and Motor Developmental Assessment

Timepoint [2]

2 years corrected age

Primary outcome [3]

Scores on the Toddler Sensory Profile 2,

Timepoint [3]

2 years corrected age

Secondary outcome [1]

Scores on the Edinburgh Post Natal Depression Scale

Timepoint [1]

5 weeks corrected age

Secondary outcome [2]

Scores on the Infant Toddler Social-Emotional Assessment

Timepoint [2]

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?

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]

Nambour General Hospital - Nambour

Recruitment hospital [2]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [3]

The Sunshine Coast Private Hospital - Buderim

Recruitment postcode(s) [1]

4560 - Nambour

Recruitment postcode(s) [2]

4575 - Birtinya

Recruitment postcode(s) [3]

4556 - Buderim

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Practitioner Research Grant,
Allied Health Professions' Office of Queensland, Health Service and Clinical Innovation Division, Department of Health.

Address [1]

Allied Health Professions'
Office of Queensland
GPO Box 48
Brisbane QLD 4001

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Wishlist Sunshine Coast Health Foundation

Address [2]

Sunshine Coast University Hospital
6 Doherty Street
Birtinya QLD 4575

Country [2]

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]

Individual

Name [1]

Professor Roslyn Boyd

Address [1]

Queensland Cerebral Palsy and Rehabilitation Research Centre
7th Floor, Block 6
Royal Brisbane and Women's Hospital
Herston, QLD 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children’s Health Queensland Human Research Ethics Commitee (HREC)

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/05/2013

Ethics approval number [1]

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

Mrs Rebecca Caesar

Address

Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560

Country

Australia

Phone

+61 7 5202 7493

Fax

+61 7 5202 2688

rebecca.caesar@health.qld.gov.au

Contact person for public queries

Name

Rebecca Caesar

Address

Paediatric Allied Health, Sunshine Coast University Hospital, Reply Paid, PO Box 5340, Sunshine Coast M.C QLD 4560

Country

Australia

Phone

+61 7 5202 7493

Fax

+61 7 5202 2688

rebecca.caesar@health.qld.gov.au

Contact person for scientific queries

Name

Roslyn Boyd

Address

Rm 611, level 6, Children's Health Research Centre,
62 Graham Street, South Brisbane, 4010. Queensland. Australia

Country

Australia

Phone

+61 7 3069 7372

Fax

no fax number

r.boyd@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	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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