Clincosm LogoSign in Get a demo

Neonatal Neurological Examination to Detect Infants at Risk

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05772416
Collaborator
(none)
100
Enrollment
1
Location
48
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study aims to establish the diagnostic vcalue of a structured neurological examination to detect eraly neurological abnormlaities in infants at risk of neurological abnormlaiyies.

    Infants at risk of neurological abnormlaiyies, such as very pèretrm infants and infants with asphyxia or with overt neyurologocal abnormla signs suh as convilsions will be assessed with a structured neurological examination and followed over time.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Diagnostic Value of the Neonatal Neurological Examination to Detect Infants at Risk for Neurological Abnormalities
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Aug 31, 2025
    Anticipated Study Completion Date :
    Aug 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Hammersmith Neonatal and infant Neurological examination [5 years]

      neurological examination witha score from 0 to 75 with 75 indicating best performance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Hours to 1 Week
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    all newborns with neonatal encephaolopathy or at risk for neurological abnormlaities, such as preterm infants born below 34 weeks or those with convusions

    Exclusion Criteria:

    families unwilling to sign consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico gemelli Rome Italy

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    • Principal Investigator: Eugenio Mercuri, F Policlinico Gemelli IRCCS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05772416
    Other Study ID Numbers:
    • 4313
    First Posted:
    Mar 16, 2023
    Last Update Posted:
    Mar 16, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Brain Diseases

    Study Results

    No Results Posted as of Mar 16, 2023