ULTRA-EARLY PARENT ADMINISTERED PHYSIOTHERAPY FOR INFANTS AT HIGH RISK OF CEREBRAL PALSY OR MOTOR DELAY – A RANDOMISED CONTROLLED FEASIBILITY TRIAL

B. Lucas¹, J. Bowen², C. Morgan², I. Novak², N. Badawi², E. Elliott², G. Dwyer³, L. Harvey¹, A. Thevarajah⁴

¹The University of Sydney, John Walsh Centre for Rehabilitation Research, Sydney, Australia, ²The University of Sydney, Faculty of Medicine and Health, Sydney, Australia, ³University of Western Sydney, Physiotherapy, Sydney, Australia, ⁴Australian Catholic University, Sydney, Australia

Background: Infants admitted to neonatal intensive care units (NICU) are at higher risk of developmental problems including cerebral palsy (CP) and motor delay. Recent neuroplastic literature suggests that the developing brain has the capacity for repair, especially in the first 2 years of life and early intervention (EI) may promote this. Many NICU follow-up programs however don’t focus on EI until after 3 months corrected age (CA). Is it possible that EI delivered even earlier commencing during admission to NICU may further optimise the critical period of neural development? The Best Start Trial investigates the value of this approach.

Purpose: To determine if parent administered motor therapy delivered from 34 weeks’ gestational age (GA) to 16 weeks CA to preterm/term infants at high risk of CP or motor delay improves motor outcomes at 16 weeks CA compared to usual care? To evaluate secondary outcomes at 12 months CA to ascertain the longer-term developmental outcomes.

Methods: Single blind randomised controlled trial of experimental care versus usual care. Infants were recruited from Royal North Shore Hospital, NICU (Sydney, Australia) and were eligible for the trial if they resided in Northern Sydney Local Health District, the parents/caregiver spoke English and met predetermined criteria for being at risk of CP or motor delay. The primary outcome was the Alberta Infant Motor Scale (AIMS) at 16 weeks CA. Secondary outcomes measures occurred at 12 weeks CA: Prechtls General Movements Assessment (GM’s); 16 weeks CA: the Depression Anxiety and Stress Score (DASS-21) and Parents Perceptions Survey (15-point scale); and at 12 months: Bayley Scales of Infant Development version 4 (BSID4) and Neurological Examination.

Results: All n=30 infants enrolled received the assigned intervention until 16 weeks CA. There were no between group differences for the AIMS raw score at 16 weeks CA (- 0.2, 95%CI -2.4 to 2.0). The parents “perception of treatment effectiveness” (2.1, 95%CI 0.5 to 3.7) and parents “perception of change (1.8, 95%CI 0.6 to 3.1) however were both significant in favour of the experimental group. There was no significant between group difference in parents “perception of burden of care”, the GM's or the DASS-21 results. The BSID4 and Neurological Examination results are pending in November 2022 when all infants have been evaluated.

Conclusions: The experimental intervention did not result in advanced motor outcomes at 16 weeks CA however parents’ perceptions of treatment effectiveness and treatment change were significantly in favour of the experimental approach.

Implications: Despite randomisation, baseline differences existed with the experimental group having higher numbers of infants with complex diagnoses and twice as many infants with significant developmental trajectories compared to the usual care group. Furthermore, COVID lockdowns required the use of a much blunter assessment instrument, the AIMS, which was able to be delivered through telehealth platforms than was in the original methods design. Between group differences may have been dissolved by both these factors. Evaluation of the 12 months BSID4 and Neurological Examination will further determine the value of this early intervention approach.

Funding acknowledgements: The Research Foundation, The Cerebral Palsy Alliance (Sydney, Australia).
Ramsay HealthCare (Sydney, Australia).

Keywords:
cerebral palsy
ultra-early intervention
motor learning

Topics:
Paediatrics
Paediatrics: cerebral palsy

Did this work require ethics approval? Yes

Institution: Northern Sydney Local Health District

Committee: Human Research Ethics Committee

Ethics number: 2019/ETH08284