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

Switzerland80 participantsStarted 2023-04-01

Plain-language summary

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.

Who can participate

Age range23 Weeks – 32 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Preterm infants * Gestational age \< 32 weeks * GMOS ≤ 23/42 at 33 0/7 - 34 6/7 weeks PMA * General medical condition stable to the extent that video imaging of the GMs in supine position is possible (minimal underpinning and non-invasive ventilation or oxygen support are allowed) * Hospitalisation at the NICU at University Hospital Zurich (USZ) or Inselspital Bern * Place of residence located in order to ensure appropriate follow-up outpatient physiotherapy treatment, if indicated * Parent or legal guardian must be able to give informed consent as documented by signature Exclusion Criteria: * Syndromal disease * Neuromuscular disease (e.g. myelomeningocele, spinal muscular atrophy) * Underlying musculoskeletal disease (e.g. arthrogryposis, clubfoot) * Participation in other studies if it is anticipated that the interventions in each case could affect the outcome of the other study * Inability of the legal guardian to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

What they're measuring

Motor Optimality Score for 3- to 5-Month-Old Infants - Revised (Einspieler et al. 2019)

Timeframe: at three months corrected age

Trial details

NCT IDNCT07449312

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05