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Neurobehavioural Development of Infants Born <30 Weeks Gestational Age Between Birth and Five Years of Age (VIBeS-2)

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ClinicalTrials.gov Identifier: NCT03172104
Recruitment Status : Unknown
Verified May 2017 by Alicia Spittle, Murdoch Childrens Research Institute.
Recruitment status was:  Recruiting
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
Alicia Spittle, Murdoch Childrens Research Institute

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.


Condition or disease
Preterm Infant Motor Activity Neurodevelopmental Disorders Developmental Coordination Disorder

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurobehavioural Development of Infants Born <30 Weeks Gestational Age and Their Parents Psychological Wellbeing Between Birth and Five Years of Age
Actual Study Start Date : January 1, 2011
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Group/Cohort
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.



Primary Outcome Measures :
  1. Motor development [ Time Frame: 4.5-5 years corrected age ]
    Movement Assessment Battery for Children - 2nd Edition


Secondary Outcome Measures :
  1. Physical Activity [ Time Frame: 4.5-5 years corrected age ]
    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.

  2. Pediatric Evaluation of Disability Inventory [ Time Frame: 4.5-5 years corrected age ]
    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.

  3. Little DCD Questionnaire [ Time Frame: 4.5-5 years corrected age ]
    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

  4. General Cognitive Function [ Time Frame: 4.5-5 years corrected age ]
    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.



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants <30 weeks' GA at birth admitted to one of the neonatal nurseries at the Royal Women's Hospital in Melbourne, Australia.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172104


Contacts
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Contact: Alicia J Spittle, PhD 61413599862 aspittle@unimelb.edu.au
Contact: Joy E Olsen, PhD joy.olsen@thewomens.org.au

Locations
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Australia, Victoria
Murdoch Childrens Research Institute Recruiting
Parkville, Victoria, Australia, 3058
Contact: Alicia J Spittle, PhD    413599862    aspittle@unimelb.edu.au   
Contact: Joy E Olsen, PhD         
Sponsors and Collaborators
Murdoch Childrens Research Institute
University of Melbourne
Investigators
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Principal Investigator: Alici J Spittle, PhD Murdoch Childrens Research Institute

Publications:
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Responsible Party: Alicia Spittle, Associate Professor Alicia Spittle, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT03172104     History of Changes
Other Study ID Numbers: HREC34147E
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Neurodevelopmental Disorders
Motor Skills Disorders
Pathologic Processes
Mental Disorders