NCT05907837

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jul 2023Jun 2028

First Submitted

Initial submission to the registry

June 2, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

June 2, 2023

Last Update Submit

September 28, 2023

Conditions

Cerebral PalsyNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

AgeUp to 40 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

  • Death prior to discharge from the neonatal unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cork University Maternity Hospital

Cork, Ireland

RECRUITING

Coombe Women and Infants University Hospital

Dublin, Ireland

RECRUITING

National Maternity Hospital

Dublin, Ireland

RECRUITING

The Rotunda Hospital

Dublin, Ireland

RECRUITING

University Maternity Hospital Limerick

Limerick, Ireland

NOT YET RECRUITING

MeSH Terms

Conditions

Cerebral PalsyNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian H Walsh

CONTACT

021 42020529brianhenry.walsh@ucc.ie

Teresa Berkery

CONTACT

t.berkery@ucc.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 18, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IE(5)