Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03211533 |
Other study ID # |
RF-2013-02358095 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 22, 2017 |
Est. completion date |
June 23, 2020 |
Study information
Verified date |
October 2019 |
Source |
IRCCS Fondazione Stella Maris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.