Clinical trial NCT03211533: Early Identification of Infants at Risk of Cerebral Palsy
Official title: CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Preterm Infant
Keywords: infants at risk of cerebral palsy
MRI
general movements
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 99
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this observational study will be enrolled infants, born a term or preterm, with very early neurological signs (at term age) and evidences of brain lesion during ultrasound brain screening that are considered at risk for the development of CP.

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.

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

Primary outcomes:
measure: Fidgety Movements at 12 weeks (post-term age)
timeFrame: 12 weeks post-term age
Secondary outcomes:
measure: Writhing Movements at 40 weeks (term age)
timeFrame: 40 weeks (term age)
measure: Magnetic resonance imaging rating scale
timeFrame: up to 6 weeks (post-term age)
Other outcomes:
Locations:
city: Calambrone
country: Italy
facility: IRCCS Fondazione Stella Maris
state: Pisa
Study officials:
References:
citation: Menici V, Antonelli C, Beani E, Mattiola A, Giampietri M, Martini G, Rizzi R, Cecchi A, Cioni ML, Cioni G, Sgandurra G; Caretoy-R Consortium. Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy. Front Pediatr. 2021 Jul 19;9:673956. doi: 10.3389/fped.2021.673956. eCollection 2021.
citation: Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.