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Clinical Trial Summary

This study aims to assess the effect of a parent-administered intervention program based on MIT-PB in preterm with abnormal general movements during the preterm period. We will describe the short and long-term differences between infants exposed to MIT-PB and infants who follow current standard care.


Clinical Trial Description

The quasi-experimental design has been planned to assess the effect of a physiotherapy program carried out in neonatal intensive care and at home during the first months of life. Preterm babies born before 32 weeks gestational age (GA) and/or with less than 1500g showing an abnormal General Movement Assessment (GMA) at 34-36 weeks will be included. Standardized tests will be performed at baseline, at term, 44 weeks post-menstrual age (PMA), 54 weeks PMA, 6 months, and 12 months. A qualitative study has been designed to assess the physiotherapy performance and parents' experience. Two different Hospitals with similar care protocols and sizes will recruit the sample (n=36). The Intervention group (n=18) will be located at Hospital Josep Trueta of Girona and the control group (n=18) will be located at Hospital Parc Taulí of Sabadell (Barcelona). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05319158
Study type Interventional
Source Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Contact Susana Trallero, MsC
Phone 675255810
Email sue.trallero@gmail.com
Status Recruiting
Phase N/A
Start date April 30, 2022
Completion date September 1, 2025

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