CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- IRCCS Fondazione Stella Maris
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Fidgety Movements at 12 weeks (post-term age)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of life performing a periodic neurological assessment (Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM).
Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
Detailed Description
Scientific literature review shows evidence that early intervention, especially when performed in the first months of life, when the brain plasticity shows its great expressivity, has positive effects on neurodevelopmental outcomes. In this framework the early identification of infants at risk for neurodevelopmental disorders is a major prerequisite to start very early an intervention programme. To families of infants, born in Neonatal Units involved in this study, will be asked with written informed consent, to participate in this observational study that aims to early identify, through a rigorous and standardized follow-up, infants at high risk for CP. Infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of development by the clinical team (Child Neurologists and Neonatologists) performing a periodic neurological assessment through examination of the Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination, at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, within 6 weeks post-term age enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM). During the conventional RM examination, when possible, a fMRI perceptive task will be also performed to evaluate possible predictor factors to the responsiveness to the early intervention. Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
Investigators
Eligibility Criteria
Inclusion Criteria
- •neurological signs (Hammersmith Infant Neurological Examination/General Movement Assessment according Precthl's).
- •signs of brain injury identified at ultrasound brain exam
Exclusion Criteria
- •brain malformations
- •severe sensory deficits
Outcomes
Primary Outcomes
Fidgety Movements at 12 weeks (post-term age)
Time Frame: 12 weeks post-term age
The Prechtl's General Movements Assessment is a non-invasive and cost-effective way to identify neurological issues which may lead to cerebral palsy and other developmental disabilities. The Fidgety movements are usually assessed between 9-20 weeks post-term age, showing the best expression at 12 weeks post term age. Infants whose Fidgety movements are absent or abnormal are at higher risk of neurological conditions, in particular for cerebral palsy.
Secondary Outcomes
- Writhing Movements at 40 weeks (term age)(40 weeks (term age))
- Magnetic resonance imaging rating scale(up to 6 weeks (post-term age))