Movement Imitation Therapy v/s Standard Care in Very Preterm and Extreme Preterm Neonates: A Randomised Controlled Trial (MOTIVE trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- General Movement Optimality Score- Revised (GMOS-R) at 34 weeks Post Menstrual Age (PMA)
Study Overview
Brief Summary
The MOTIVE trial is a randomized controlled study comparing Movement Imitation Therapy (MIT) to standard care in very preterm and extreme preterm neonates. Conducted at Sri Ramachandra Institute of Higher Education and Research, the study aims to assess the impact of MIT on neurodevelopmental outcomes using the General Movement Optimality Score-Revised (GMOS-R) at 34 weeks post-menstrual age (PMA). The trial will involve stratified randomization of eligible preterm neonates, with MIT sessions incorporating guided limb movements mimicking normal general body movements. Secondary outcomes include GMOS-R at 5 months of corrected age, MRI/Neurosonogram findings at term-equivalent age, and the Hammersmith Neonatal Neurological Examination (HNNE) scores. The study follows ethical guidelines, ensuring informed parental consent and confidentiality, with blinded outcome assessment to minimize bias.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 7.00 Day(s) to 14.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All pre-term neonates born between 26wks 0/7 to 31wks 6/7 weeks gestational age, admitted in Neonatal Intensive Care unit, and who are hemodynamically stable, from their second week of life.
Exclusion Criteria
- •Neonates with genetic or congenital anomalies affecting motor function.
Outcomes
Primary Outcomes
General Movement Optimality Score- Revised (GMOS-R) at 34 weeks Post Menstrual Age (PMA)
Time Frame: At 34 weeks Post Menstrual Age (PMA)
Secondary Outcomes
- 1. GMOS-R at 5 months of chronological age(2. Neurosonogram/MRI brain at term equivalent age)
Investigators
Dr Meghana S
Sri Ramachandra Institute of Higher Education and Research