Movement Imitation Therapy for Preterm Babies (MIT-PB) - A Pilot Study

Background: Very preterm babies are at high risk for developmental disorders. Prechtl's General Movements (GMs) Assessment is a valuable and reliable tool in infants until three months corrected age for predicting their further developmental difficulties, particularly cerebral palsy. However, a specific therapeutic intervention based on this assessment, has not yet been defined. Soloveichick et al. (2019) described the Movement Imitation Therapy for Preterm Babies (MIT-PB) as a promising novel approach based on the model of GMs and the current knowledge of brain development. Study design and objectives: The present pilot prospective controlled intervention study aims to clarify whether preterm infants born with a gestational age (GA) \<32 0/7 weeks showing abnormal GMs at 33-34 weeks postmenstrual age (PMA) differ in their neurodevelopmental outcome at three and 24 months corrected age depending on whether they were treated with usual care physiotherapy or additionally with MIT-PB. Methods: The participants are recruited at two study sights over 18 months, whereby 40 participants per group are estimated. MIT-PB starts at the NICU and is continued until 52 weeks PMA. The parents are introduced in the method in order to take over a part of the treatment right from the beginning and continue after discharge. The essential content of MIT-PB is to manually guide the infant's abnormal movements into movements as similar as possible to normal GMs. The primary outcome is the Motor Optimality Score Revised (MOS-R) at three months corrected age. The analysis for the primary endpoint (MOS-R at T2) will be conducted using an analysis of covariance (ANCOVA) with the treatment group (intervention/control) as fixed factor and GMOS at T0 (baseline) as covariate. Several covariates are included in the analysis. Furthermore, neuromotor outcome at term (GMOS) and at two years corrected age (Bayley Scales of Infant and Toddler Development III), as well as parental self-efficacy (Perceived Maternal Parental Self-efficacy tool(PMP S-E)) and dose-response of MIT-PB are evaluated.

NCT Number	NCT07449312
Lead Sponsor	University of Zurich Collaborators: Insel Gruppe AG, University Hospital Bern
Conditions	Preterm Birth, Early Intervention, General Movements
Enrollment	80 participants
Start Date	2023-04-01
Primary Completion	2026-05 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-04