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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03172104
Ethics application status
Date submitted
29/05/2017
Date registered
1/06/2017
Date last updated
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] 0 0
HREC34147E
Universal Trial Number (UTN)
Trial acronym
VIBeS-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm Infant 0 0
Motor Activity 0 0
Neurodevelopmental Disorders 0 0
Developmental Coordination Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
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] 0 0
Motor development - Movement Assessment Battery for Children - 2nd Edition
Timepoint [1] 0 0
4.5-5 years corrected age
Secondary outcome [1] 0 0
Physical Activity - A small Axivity AX3 tri-axial accelerometer-based activity monitor will be worn on the ankle over a consecutive seven day period to obtain information about the number of steps taken per day and sedentary behaviour patterns. The child and caregiver will be educated on wearing the device, and the child will wear it 24 hours a day for seven days before returning it in a pre-paid envelope.
Timepoint [1] 0 0
4.5-5 years corrected age
Secondary outcome [2] 0 0
Pediatric Evaluation of Disability Inventory - The PEDI-CAT (Pediatric Evaluation of Disability Inventory)25 is a questionnaire that will be used to assess abilities in three functional domains: Daily Activities (e.g. dressing, feeding), Mobility (e.g. transfers, steps and inclines, running and playing) and Social/Cognitive (e.g. interaction, communication, self-management). It provides standard and scaled scores based on normative and disability samples, and is validated for children with a range of physical and behavioural conditions, including children who use mobility devices. Caregivers will complete the PEDI-CAT on an iPad during their child's assessment.
Timepoint [2] 0 0
4.5-5 years corrected age
Secondary outcome [3] 0 0
Little DCD Questionnaire - The Little Developmental Coordination Disorder Questionnaire (Little DCD)27 is a parent-completed measure which is designed to identify subtle motor problems in children. This questionnaire has been revised to be appropriate for use by parents of children aged five to seven years of age and its concurrent validity has been established with the MABC-2.28
Timepoint [3] 0 0
4.5-5 years corrected age
Secondary outcome [4] 0 0
General Cognitive Function - General cognitive function will be assessed using the Wechsler Preschool and Primary Scale of Intelligence (Fourth Edition, Australian and New Zealand Standardised Edition; WPPSI-IV).29 The WPPSI-IV has Australasian norms and is the gold standard measure for assessing general intellectual ability. It provides measures of key cognitive domains: full-scale IQ, verbal comprehension, visual-spatial reasoning, fluid reasoning, working memory, and processing speed.
Timepoint [4] 0 0
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
No limit
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Childrens Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3058 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0

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/show/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 0 0
Alici J Spittle, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alicia J Spittle, PhD
Address 0 0
Country 0 0
Phone 0 0
61413599862
Fax 0 0
Email 0 0
aspittle@unimelb.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03172104