Active — Not RecruitingNot Applicable

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 range

23 Weeks – 32 Weeks

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Preterm Birth trials