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Early Detection & Intervention of Cerebral Palsy in Ireland

NCT ID: NCT05907837

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2028-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Palsy Neurodevelopmental Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Maternity Hospital, Ireland

OTHER

Sponsor Role collaborator

University Maternity Hospital Limerick

UNKNOWN

Sponsor Role collaborator

Cork University Maternity Hospital

OTHER

Sponsor Role collaborator

Coombe Women and Infants University Hospital

OTHER

Sponsor Role collaborator

The Rotunda Hospital

OTHER

Sponsor Role collaborator

Cerebral Palsy Foundation

UNKNOWN

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian H Walsh

Role: PRINCIPAL_INVESTIGATOR

University College Cork

Breda Hayes

Role: PRINCIPAL_INVESTIGATOR

The Rotunda Hospital

Deirdre Sweetman

Role: PRINCIPAL_INVESTIGATOR

National Maternity Hospital

Roy Philips

Role: PRINCIPAL_INVESTIGATOR

Limerick University Maternity Hospital

John Kelleher

Role: PRINCIPAL_INVESTIGATOR

Coombe Women and Infants University Hospital

Locations

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Cork University Maternity Hospital

Cork, , Ireland

Site Status RECRUITING

Coombe Women and Infants University Hospital

Dublin, , Ireland

Site Status RECRUITING

National Maternity Hospital

Dublin, , Ireland

Site Status RECRUITING

The Rotunda Hospital

Dublin, , Ireland

Site Status RECRUITING

University Maternity Hospital Limerick

Limerick, , Ireland

Site Status NOT_YET_RECRUITING

Countries

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Ireland

Central Contacts

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Brian H Walsh

Role: CONTACT

[email protected]
021 42020529

Teresa Berkery

Role: CONTACT

[email protected]

Facility Contacts

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Brian Walsh

Role: primary

John Kelleher

Role: primary

Deirdre Sweetman

Role: primary

Breda Hayes

Role: primary

Roy Philips

Role: primary

Other Identifiers

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EDI-CPI

Identifier Type: -

Identifier Source: org_study_id

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