Early Detection & Intervention of Cerebral Palsy in Ireland

Cerebral Palsy Clinical Trial

Official title:

Early Detection & Intervention of Cerebral Palsy in Ireland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907837
• Other study ID #: EDI-CPI
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: September 2023
• Source: University College Cork
• Contact: Brian H Walsh
• Phone: 021 42020529
• Email: brianhenry.walsh[@]ucc.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Neurodevelopmental Disorders

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital	Cork
Ireland	Coombe Women and Infants University Hospital	Dublin
Ireland	National Maternity Hospital	Dublin
Ireland	The Rotunda Hospital	Dublin
Ireland	University Maternity Hospital Limerick	Limerick

Sponsors (7)

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

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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