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

NCT ID: NCT03172104

Last Updated: 2020-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 251 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2019-06-30

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.

Conditions

Preterm Infant; Motor Activity; Neurodevelopmental Disorders; Developmental Coordination Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Melbourne

OTHER

Sponsor Role: collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Alicia Spittle

Associate Professor Alicia Spittle

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alici J Spittle, PhD

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

Murdoch Childrens Research Institute

Parkville, Victoria, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 24758605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27634166 (View on PubMed)

Other Identifiers

HREC34147E

Identifier Type: -

Identifier Source: org_study_id