Early Detection & Intervention of Cerebral Palsy in Ireland

Recruiting

• Conditions: Cerebral Palsy; Neurodevelopmental Disorders

• Registration Number: NCT05907837
• Lead Sponsor: University College Cork

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-18
• Study Start: 2023-07-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2027-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (5)

University Maternity Hospital Limerick; 🇮🇪 Limerick, Ireland

Coombe Women and Infants University Hospital; 🇮🇪 Dublin, Ireland

The Rotunda Hospital; 🇮🇪 Dublin, Ireland

National Maternity Hospital; 🇮🇪 Dublin, Ireland

Cork University Maternity Hospital; 🇮🇪 Cork, Ireland