Early Detection & Intervention of Cerebral Palsy in Ireland

Sponsor
University College Cork (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05907837
Collaborator
National Maternity Hospital, Ireland (Other), University Maternity Hospital Limerick (Other), Cork University Maternity Hospital (Other), Coombe Women and Infants University Hospital (Other), The Rotunda Hospital (Other), Cerebral Palsy Foundation (Other)
1,500
5
60
300
5

Study Details

Study Description

Brief Summary

Cerebral palsy (CP) is the most common lifelong physical disability. It is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. These include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. People with CP often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. Many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. However, in most clinical settings, the age for diagnosis of CP is between 24 to 29 months, after this window of neurodevelopmental opportunity.

This project will aim to improve the Early Detection of Cerebral Palsy in Ireland. This will be achieved by implementing an evidence-based approach to follow-up of High risk infants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Early Detection & Intervention of Cerebral Palsy in Ireland
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jun 30, 2027
    Anticipated Study Completion Date :
    Jun 30, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Reduce the age of CP diagnosis in Ireland. [5 years]

      Reduce the age of diagnosis of cerebral palsy in Ireland to less than 12 months of age by using evidence based standardised motor and neurological assessments at set time points.

    2. Standardised Approach to Assessing infant at risk of CP [5 years]

      To establish a standardised approach to assessing infants at risk of CP in High Risk Follow-up Clinics across Ireland.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 40 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

    • All infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including:

    • All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight

    • All encephalopathic infants

    • Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam)

    Exclusion Criteria:
    • Death prior to discharge from the neonatal unit.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cork University Maternity Hospital Cork Ireland
    2 Coombe Women and Infants University Hospital Dublin Ireland
    3 National Maternity Hospital Dublin Ireland
    4 The Rotunda Hospital Dublin Ireland
    5 University Maternity Hospital Limerick Limerick Ireland

    Sponsors and Collaborators

    • University College Cork
    • National Maternity Hospital, Ireland
    • University Maternity Hospital Limerick
    • Cork University Maternity Hospital
    • Coombe Women and Infants University Hospital
    • The Rotunda Hospital
    • Cerebral Palsy Foundation

    Investigators

    • Principal Investigator: Brian H Walsh, University College Cork
    • Principal Investigator: Breda Hayes, The Rotunda Hospital
    • Principal Investigator: Deirdre Sweetman, National Maternity Hospital
    • Principal Investigator: Roy Philips, Limerick University Maternity Hospital
    • Principal Investigator: John Kelleher, Coombe Women and Infants University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College Cork
    ClinicalTrials.gov Identifier:
    NCT05907837
    Other Study ID Numbers:
    • EDI-CPI
    First Posted:
    Jun 18, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 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:

    Study Results

    No Results Posted as of Jun 26, 2023