About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Sequential
Treatments tested in this trial
MIT-PB, movement imitation therapy for preterm.
Other interventionThe instant an infant showed CS or PR movements, the therapists (or a therapist and a parent) intervened by gently guiding the infants' limbs so as to maneuver and smoothen their movements, thereby imitating normal GM sequences as closely as possible, adding variability to the movement
Treatment groups
Trial outcomes
Primary outcomes
The quality of General Movement by General Movements Optimality Score (GMOS-R) 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-R global assessment can be Normal (N), Poor Repertoire (PR), Cramped Syncronized (CS) or Chaotic (CH). On the detailed score ,the maximum value is 38. 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.
Secondary outcomes
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.
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.
Other outcomes
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.
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.
Sponsors and contacts
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Lead sponsor
Hospital Sant Joan de Deu
Collaborator
Hospital Parc Taulí (Sabadell, Barcelona)
Collaborator