A randomised controlled trial of physiotherapy intervention compared to no intervention in pre-school children born extremely preterm.

Not Applicable

Completed

• Conditions: Extremely premature/extremely low birth weight children; Physical Medicine / Rehabilitation - Physiotherapy; Public Health - Health service research; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12613000950763
• Lead Sponsor: Assoc Prof Peter Gray

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

The participants will have been born less than 1000g or less than 28 weeks gestational age and will have been managed in the Neonatal Intensive Care Unit at the Mater Mothers' Hospital, Brisbane, Australia. Children will be aged 4-4.5 years corrected for prematurity when commencing involvement in the study and will not have started their preparatory (prep) year of schooling.
Included children will have attended their 4 year (corrected age) Growth and Development Clinic follow-up assessment and will have a score from the Neurosensory Motor Developmental Assessment (NSMDA) of 9 to <13 and an IQ of >70 on the Stanford Binet Intelligence Scales. Children will also live within one hour of travel time to the Mater Hospitals.

Exclusion Criteria

Children with significant congenital anomalies, diagnosed neurological impairments including cerebral palsy, a visual impairment not corrected by wearing corrective lenses or a hearing impairment not corrected by aids will be excluded from the study. Additionally, children will not participate if their parents/carers do not speak English, as delivery of the program including follow-up telephone calls would not be practical. Children of families who identify that they would not be able to commit to attending a 6 week physiotherapy program and returning for follow-up assessments will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified