Premature Birth Clinical Trial
— MIT-PBOfficial title:
The Effect of the Movement Imitation Therapy for Preterm Babies (MIT-PB) on Motor Behavior Quality. Quasi-experimental Design.
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.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | September 1, 2025 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 32 Weeks |
Eligibility | Inclusion Criteria: - Preterm infants born before 32w GA and less than 1500g weight. - Infants who show Abnormal General Movements (CS-PR pattern) at 34-36w postmenstrual age (PMA). - Families able to understand/speak Catalan, Spanish or English. - Families willing to participate who have the informed consent Exclusion Criteria: - Infants with congenital abnormalities and/or genetic disorders - Infants with invasive ventilation or Continuous Positive Airway Pressure (CPAP) at 36 weeks PMA. - Infants with Normal General Movements at 34-36 w PMA. - Families not willing to participate. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Josep Trueta de Girona | Girona | |
Spain | Hospital Parc Taulí de Sabadell | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | Hospital Parc Taulí, Sabadell |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Describe families experiences with the MIT-PB | • Families will fill up a questionnaire at the end of the intervention to give their opinion about their experience with the therapy. | 6 months CA | |
Other | Study family's participation and treatment adherence | Parents will get a software application in order to register the number of treatments achieved during the intervention period. | 6 months CA | |
Primary | The quality of General Movement by General Movements Optimality Score (GMOS) and Motor Optimality Score (MOS). | We will videotape General Movements at 34, 38-40, 44 and 54 weeks PMA. The baseline measure( 34w) will be performed by the main researcher and an independent and experienced certified rater. This rater will be blind regarding infant group.
The assessments at 38-40, 44 and 54 weeks will be performed by the independent, blind and certified rater in order to guarantee the study validity. The GMOS global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 42. The MOS global assessment can be classified as Fidgety (F), Abnormal Fidgety (AF) or Absent Fidgety (F-). On the detailed score the maximum value is 28. Higher scores in both scales are correlated with better global outcome. |
Each participant will be assessed from birth to the 54 weeks PMA. | |
Secondary | Motor development by Hammersmith Infant Neurological Scale (HINE). | Infants will assessed at 6 months CA by an independent neuro-pediatrician using the HINE.
It is a standardized neurological exam for infants adjusted age 2 to 24 months. The HINE evaluates nerve function, movements, reflexes and reactions, posture, and tone and can help clinicians identify movement disorders including cerebral palsy (CP)The maximum global score is 78. Higher scores indicate better neurological performance. |
6 months CA | |
Secondary | Global development by Bayley III | An independent neuropsychologists will assess Global Development by Bayley III at 12 months CA.
Bayley-III provides information about whether a child's developmental trajectory in the cognitive domain is proceeding as expected, relative to same-age peers. It also includes a motor score, and fine and gross motor subtest scores. The assessment indicates mild, moderate or severe delay. |
12 months CA |
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