Clinical trial NCT05907837: Early Detection & Intervention of Cerebral Palsy in Ireland
Official title: Early Detection & Intervention of Cerebral Palsy in Ireland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Neurodevelopmental Disorders
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: National Maternity Hospital, Ireland
name: University Maternity Hospital Limerick
name: Cork University Maternity Hospital
name: Coombe Women and Infants University Hospital
name: The Rotunda Hospital
name: Cerebral Palsy Foundation
First posted: 2023-06-18
Enrollment: 1500
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduce the age of CP diagnosis in Ireland.
timeFrame: 5 years
measure: Standardised Approach to Assessing infant at risk of CP
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
city: Dublin
country: Ireland
facility: Coombe Women and Infants University Hospital
city: Dublin
country: Ireland
facility: National Maternity Hospital
city: Dublin
country: Ireland
facility: The Rotunda Hospital
city: Limerick
country: Ireland
facility: University Maternity Hospital Limerick
Study officials:
affiliation: University College Cork
name: Brian H Walsh
role: PRINCIPAL_INVESTIGATOR
affiliation: The Rotunda Hospital
name: Breda Hayes
role: PRINCIPAL_INVESTIGATOR
affiliation: National Maternity Hospital
name: Deirdre Sweetman
role: PRINCIPAL_INVESTIGATOR
affiliation: Limerick University Maternity Hospital
name: Roy Philips
role: PRINCIPAL_INVESTIGATOR
affiliation: Coombe Women and Infants University Hospital
name: John Kelleher
role: PRINCIPAL_INVESTIGATOR
References: