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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03172104

Registration number

NCT03172104

Ethics application status

Date submitted

29/05/2017

Date registered

1/06/2017

Titles & IDs

Public title

Neurobehavioural Development of Infants Born <30 Weeks Gestational Age Between Birth and Five Years of Age

Scientific title

Neurobehavioural Development of Infants Born <30 Weeks Gestational Age and Their Parents Psychological Wellbeing Between Birth and Five Years of Age

Secondary ID [1]

HREC34147E

Universal Trial Number (UTN)

Trial acronym

VIBeS-2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preterm Infant

Motor Activity

Neurodevelopmental Disorders

Developmental Coordination Disorder

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Very preterm group - Preterm infants \<30 weeks' GA at birth admitted to one of the neonatal nurseries at the Royal Women's Hospital in Melbourne, Australia.

Inclusion criteria: Infants admitted to the Royal Women's Hospital, Melbourne, Australia, neonatal nurseries, born \<30 weeks' GA. Exclusion criteria: (i) infants with congenital abnormalities known to affect neurodevelopment and (ii) infants with non-English speaking parents.

Term control group - Inclusion criteria: Infants admitted to the Royal Women's Hospital Melbourne, Australia, born \>36 completed weeks' GA and weighing \>2500 g. Exclusion criteria: (i) infants with congenital abnormalities known to affect neurodevelopment (ii) infants requiring admission to neonatal intensive or special care nursery and (iii) infants with non-English speaking parents.

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Motor development

Timepoint [1]

4.5-5 years corrected age

Secondary outcome [1]

Physical Activity

Timepoint [1]

4.5-5 years corrected age

Secondary outcome [2]

Pediatric Evaluation of Disability Inventory

Timepoint [2]

4.5-5 years corrected age

Secondary outcome [3]

Little DCD Questionnaire

Timepoint [3]

4.5-5 years corrected age

Secondary outcome [4]

General Cognitive Function

Timepoint [4]

4.5-5 years corrected age

Eligibility

Key inclusion criteria

* Infants admitted to the Royal Women's Hospital, Melbourne, Australia, neonatal nurseries, born <30 weeks' gestational age

Minimum age

0 Years

Maximum age

5 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* (i) infants with congenital abnormalities known to affect neurodevelopment and (ii) infants with non-English speaking parents.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2011

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

30/06/2019

Sample size

Target

Accrual to date

Final

251

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Murdoch Childrens Research Institute - Parkville

Recruitment postcode(s) [1]

3058 - Parkville

Funding & Sponsors

Primary sponsor type

Other

Name

Murdoch Childrens Research Institute

Address

Country

Other collaborator category [1]

Other

Name [1]

University of Melbourne

Address [1]

Country [1]

Ethics approval

Ethics application status

Summary

Brief summary

Research question: The primary aim of this study is to compare the prevalence of motor impairment from birth to five years of age between children born \<30 weeks and term-born controls, and to determine whether persistent abnormal motor assessments in the newborn period in those born \<30 weeks predict abnormal motor functioning at age five years. Secondary aims for both children born\<30 weeks and term children are i) to determine whether novel early magnetic resonance imaging (MRI) - based structural or functional biomarkers are detectable in the neonatal period that can predict motor impairments at five years, ii) to investigate the association between motor impairments and concurrent deficits in body structure and function at five years of age, and iii) to explore how motor impairments at five years, including abnormalities of gait, postural control and strength, are associated with concurrent functional outcomes including physical activity, cognitive and learning ability, behavioural and emotional problems.

Design: Prospective longitudinal cohort study. Participants and Setting: 150 preterm children (born \<30 weeks) and 151 term-born children (born \>36 completed weeks' gestation and weighing\>2499 g) admitted to the Royal Women's Hospital, Melbourne, were recruited at birth and will be invited to participate in a five-year follow-up study.

Procedure: This study will examine previously collected data (from birth to two years) that comprises the following: detailed motor assessments and structural and functional brain MRI images. At five years, preterm and term children will be examined using comprehensive motor assessments including the Movement Assessment Battery for Children - 2nd edition and measures of gait function through spatiotemporal (assessed with the GAITRite® Walkway), dynamic postural control (assessed with Microsoft Kinect) variables and hand grip strength (assessed with a dynamometer); and measures of physical activity (assessed using accelerometry), cognitive development (assessed with Wechsler Preschool and Primary Scale of Intelligence) and emotional and behavioural status (assessed with the Strengths and Difficulties Questionnaire and the Developmental and Wellbeing Assessment). Caregivers will be asked to complete questionnaires on demographics, physical activity, activities of daily living and motor function (assessed with Pediatric Evaluation of Disability Inventory, Pediatric Quality of Life Questionnaire, the Little Developmental Co-ordination Questionnaire and an activity diary) at the 5 year assessment.

Analysis: For the primary aim the prevalence of motor impairment from birth to 5 years will be compared between children born \<30 weeks and term-born peers using the proportion of children classified as abnormal at each of the time points (term age, one, two and five years). Persistent motor impairments during the neonatal period will be assessed as a predictor of severity of motor impairment at 5 years of age in children born \<30 weeks using linear regression. Models will be fitted using generalised estimating equations with results reported using robust standard errors, to allow for the clustering of multiple births.

Discussion/Significance: Understanding the developmental precursors of motor impairment in children born \<30 weeks is essential to limit disruption to skill development, and potential secondary impacts on physical activity, participation, academic achievement, self-esteem and associated outcomes, such as obesity, poor physical fitness and social isolation. Better understanding of motor skill development will enable targeting of intervention and streamlining of services to the individuals who are at highest risk of motor impairments.

Trial website

https://clinicaltrials.gov/study/NCT03172104

Trial related presentations / publications

Spittle AJ, Thompson DK, Brown NC, Treyvaud K, Cheong JL, Lee KJ, Pace CC, Olsen J, Allinson LG, Morgan AT, Seal M, Eeles A, Judd F, Doyle LW, Anderson PJ. Neurobehaviour between birth and 40 weeks' gestation in infants born <30 weeks' gestation and parental psychological wellbeing: predictors of brain development and child outcomes. BMC Pediatr. 2014 Apr 24;14:111. doi: 10.1186/1471-2431-14-111.
Spittle AJ, McGinley JL, Thompson D, Clark R, FitzGerald TL, Mentiplay BF, Lee KJ, Olsen JE, Burnett A, Treyvaud K, Josev E, Alexander B, Kelly CE, Doyle LW, Anderson PJ, Cheong JL. Motor trajectories from birth to 5 years of children born at less than 30 weeks' gestation: early predictors and functional implications. Protocol for a prospective cohort study. J Physiother. 2016 Oct;62(4):222-3. doi: 10.1016/j.jphys.2016.07.002. Epub 2016 Aug 5.

Public notes

Contacts

Principal investigator

Name

Alici J Spittle, PhD

Address

Murdoch Childrens Research Institute

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

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?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03172104

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03172104