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Early Identification of Infants at Risk of Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03211533
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
IRCCS Fondazione Stella Maris

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.


Condition or disease
Cerebral Palsy Preterm Infant

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
Actual Study Start Date : July 22, 2017
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Writhing Movements at 40 weeks (term age) [ Time Frame: 40 weeks (term age) ]
    The 'writhing movements' (described in the Prechtl's General Movements Assessment) are present from term age until 8 weeks post-term age. The evaluation at 40 weeks is a key point for the assessment both in preterm and at term infants. Infants whose writhing movements are abnormal could be considered at risk for neurodevelopmental disabilities; they have been carefully monitored in the fidgety period (see primary outcome measure).

  2. Magnetic resonance imaging rating scale [ Time Frame: up to 6 weeks (post-term age) ]
    Infants recruited will perform, according to gold standard clinical guidelines, a MRI study of the brain lesion previously identified with brain ultrasound. MRI will allow to better study the type of lesion. It will be quantified according to a validated visual semi-quantitative rating scale that uses a reliable and valid anatomical template for a graphical representation of abnormal MRI findings with detailed scoring of relative brain structures. During the MRI a task of fMRI will be performed to identify predictors of response to treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211533


Contacts
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Contact: Giovanni Cioni 050886233 gcioni@fsm.unipi.it
Contact: Giuseppina Sgandurra gsgandurra@fsm.unipi.it

Locations
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Italy
IRCCS Fondazione Stella Maris Recruiting
Calambrone, Pisa, Italy, 56128
Contact: Giuseppina Sgandurra, MD, PhD       g.sgandurra@fsm.unipi.it   
Sponsors and Collaborators
IRCCS Fondazione Stella Maris
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier: NCT03211533    
Other Study ID Numbers: RF-2013-02358095
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Fondazione Stella Maris:
infants at risk of cerebral palsy
MRI
general movements
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases