PREBO-6: Prediction of childhood Brain Outcomes in infants born preterm

Not Applicable

Recruiting

• Conditions: Brain development in preterm infants; Prematurity; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12619000155190
• Lead Sponsor: Dr Joanne George

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Children are eligible for this study if they participated in the PPREMO or PREBO prospective study, and turn 6 years corrected age within the study period.

Preterm participants: Children who were born at <31 weeks gestation

Term-born participants: Children who were born between 38 and 41 weeks gestation following an uncomplicated pregnancy and delivery, had a birth weight above the 10th percentile, and were not admitted to neonatal intensive or special care units following their birth.

Exclusion Criteria

1) Children diagnosed with any congenital or chromosomal abnormality that could adversely affect their neurodevelopmental outcome.
2) Non-English speaking families.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor Function<br>Children’s motor ability will be assessed using the standardised and norm-referenced Movement Assessment Battery for Children, 2nd Edition (MABC-2). [The assessment will be performed when children reach 6 years corrected age.];Composite Outcome: General Cognition<br>Children’s general cognitive development will be assessed using the Full Scale IQ score derived from the seven subtests of the Wechsler Intelligence Scale for Children (Primary Cognitive Outcome), 5th Edition: Australian and New Zealand Standardised Edition (WISC-V A&NZ). These subtests span across five core domains of verbal comprehension, visual-spatial ability, fluid reasoning, working memory and processing speed. Subtests include Similarities, Vocabulary, Block Design, Matrix Reasoning, Figure Weights, Digit Span and Coding.[The assessment will be performed when children reach 6 years corrected age.]