Early Detection & Intervention of Cerebral Palsy in Ireland

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Neurodevelopmental Disorders

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Brian H Walsh; Phone Number: 021 42020529; Email: brianhenry.walsh@ucc.ie
• Study Contact Backup: Name: Teresa Berkery; Email: t.berkery@ucc.ie

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • Cork University Maternity Hospital
    • Contact: Brian Walsh
  • Dublin, Ireland
    • Recruiting
    • Coombe Women and Infants University Hospital
    • Contact: John Kelleher
  • Dublin, Ireland
    • Recruiting
    • The Rotunda Hospital
    • Contact: Breda Hayes
  • Dublin, Ireland
    • Recruiting
    • National Maternity Hospital
    • Contact: Deirdre Sweetman
  • Limerick, Ireland
    • Not yet recruiting
    • University Maternity Hospital Limerick
    • Contact: Roy Philips

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Newborns at high risk of developing CP will be identified and consented for inclusion prior to discharge from the Neonatal unit. Approximately 1500 infants will be recruited nationally over the study period from Cork University Maternity Hospital, University Maternity Hospital Limerick, The Coombe Hospital, The Rotunda Hospital and the National Maternity Hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce the age of CP diagnosis in Ireland.	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.	5 years
Standardised Approach to Assessing infant at risk of CP	To establish a standardised approach to assessing infants at risk of CP in High Risk Follow-up Clinics across Ireland.	5 years

Collaborators and Investigators

• Sponsor: University College Cork
• Collaborators: National Maternity Hospital, Ireland; The Rotunda Hospital; Coombe Women and Infants University Hospital; Cork University Maternity Hospital; University Maternity Hospital Limerick; 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 record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Neurodevelopmental Disorders
• Other Study ID Numbers: EDI-CPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No