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Early Identification of Infants at Risk of Cerebral Palsy

NCT03211533 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 99

Last updated 2020-11-17

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Preterm Infant

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    lead OTHER

Eligibility

Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-22
Primary Completion
2020-06-01
Completion
2020-06-23

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03211533 on ClinicalTrials.gov