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Recruiting

NCT Number: NCT05907837

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.

Recruiting

Interested in participating?

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Key information

Age range

Up to 40 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital, Cork, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Reduce the age of CP diagnosis in Ireland.

    Time frame: 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.

  2. Standardised Approach to Assessing infant at risk of CP

    Time frame: 5 years

    To establish a standardised approach to assessing infants at risk of CP in High Risk Follow-up Clinics across Ireland.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian H Walsh

CONTACT

[email protected]

021 42020529

Teresa Berkery

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • Cerebral Palsy Foundation
  • Coombe Women and Infants University Hospital
  • Cork University Maternity Hospital
  • National Maternity Hospital, Ireland
  • The Rotunda Hospital
  • University Maternity Hospital Limerick

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 18, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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