LEARN 2 MOVE 0-2 years: Outcome of a randomized controlled trial on early intervention in infants at very high risk for cerebral palsy including process analysis

Introduction: Studying effects of early intervention in infants at risk for cerebral palsy is challenging, due to low prevalence, large heterogeneity and variation in natural course. Assessment of contents of intervention may improve understanding of working mechanisms. Therefore, we compared effects - including analyses of contents of physiotherapy - of COPCA (COPing with and CAring for infants with special needs) and Typical Infant Physiotherapy (TIP). Patients and method: Forty-three very high risk (VHR)-infants were included before 9 months corrected age (CA), based on either a severe brain lesion or clear neurological dysfunction. They were randomly assigned to receive 1 year of intervention, COPCA (n=23) or TIP (n=20). Infants were assessed at baseline, after 3, 6 and 12 months, and at 21 months CA with a large battery of neuromotor, cognitive, functional and family tests, with the Infant Motor Profile (IMP) as primary outcome. Physiotherapeutic intervention sessions were videotaped and quantitatively analyzed. Statistics included factoranalysis, partial correlations and multivariable mixed-effects models. Results: At RCT-level, cross-sectional outcome of COPCA and TIP was similar on primary and secondary outcomes. Mixed-effect models did not show significant differences over time between COPCA and TIP on total IMP-score. Process analyses revealed virtually no associations between physiotherapy and outcome. Conclusion: Current analyses indicate that in VHR infants 1 year of COPCA has a similar effect as 1 year of TIP. Our next step is to evaluate longitudinal outcome for secondary measures and to explore factors that influence outcome. These data will be presented at the meeting.