Status:
COMPLETED
CareToy Early Intervention in Infants at Risk for Cerebral Palsy
Lead Sponsor:
IRCCS Fondazione Stella Maris
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood disabilities with high cost for individuals and society. Early Intervention (EI), if intensive enough but affordab...
Detailed Description
The eligibility of infants, i.e. infants who meet the criteria for inclusion and exclusion (i.e infants at high-risk for CP) will be evaluated by the Neonatology team and the recruitment will be done ...
Eligibility Criteria
Inclusion
- i) abnormal neurological signs (i.e. neurological signs at the Hammersmith Infant Neurological Assessment -HINE- and according to Prechtl's Assessment GMA) at 2-4 mts post term age
- ii) neuroimaging evidence of brain lesion indicated by MRI performed around the term age (4-6 wks post term)
- iii) achieved predefined motor development scores assessed by Ages and Stages Questionnaire-3
- iv) informed consent agreement
Exclusion
- i) Drug resistant seizures,
- ii) Severe sensory deficits (blindness or deafness)
- iii) Progressive neurological disorders
- iv) Malformation of CNS
Key Trial Info
Start Date :
August 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03234959
Start Date
August 4 2017
End Date
November 4 2020
Last Update
November 17 2020
Active Locations (1)
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1
IRCCS Fondazione Stella Maris
Tirrenia, Tuscany, Italy, 56128