Cerebral PalsyNCT05907837
Early Detection & Intervention of Cerebral Palsy in Ireland
An observational study of Cerebral Palsy and Neurodevelopmental Disorders, run by University College Cork at 5 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages Up to 40 weeks
- Conditions the study is for
- Cerebral Palsy, Neurodevelopmental Disorders
- How many people
- 1,500 participants
- Where
- 5 sitesIreland
- Study dates
- 1 Jul 2023to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
- Death prior to discharge from the neonatal unit.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Teresa Berkery contact
5 sites in 1 country
Ireland5 sites, 5 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
Brian Walsh
- Recruiting
Coombe Women and Infants University Hospital
Dublin
John Kelleher
- Recruiting
National Maternity Hospital
Dublin
Deirdre Sweetman
- Recruiting
The Rotunda Hospital
Dublin
Breda Hayes
- Not yet recruiting
University Maternity Hospital Limerick
Limerick
Roy Philips
About this study
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.
- Conditions
- Cerebral Palsy, Neurodevelopmental Disorders
- Medical subject headings
- Cerebral Palsy, Neurodevelopmental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- National Maternity Hospital, Ireland, University Maternity Hospital Limerick, Cork University Maternity Hospital, Coombe Women and Infants University Hospital, The Rotunda Hospital, Cerebral Palsy Foundation
- Responsible party
- Sponsor
- Investigators
- Brian H Walsh, Principal investigator, University College CorkBreda Hayes, Principal investigator, The Rotunda HospitalDeirdre Sweetman, Principal investigator, National Maternity HospitalRoy Philips, Principal investigator, Limerick University Maternity HospitalJohn Kelleher, Principal investigator, Coombe Women and Infants University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907837
- Sponsor's protocol ID
- EDI-CPI
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2023
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection & Intervention of Cerebral Palsy in Ireland
- ClinicalTrials.gov ID
- NCT05907837
- Acronym / sponsor ID
- EDI-CPI
- Conditions
- Cerebral Palsy, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- National Maternity Hospital, Ireland, University Maternity Hospital Limerick, Cork University Maternity Hospital, Coombe Women and Infants University Hospital, The Rotunda Hospital, Cerebral Palsy Foundation
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (1 listed)
- Death prior to discharge from the neonatal unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa Berkery contact
Brian H Walsh principal investigator
University College Cork
Breda Hayes principal investigator
The Rotunda Hospital
Deirdre Sweetman principal investigator
National Maternity Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Neurodevelopmental Disorders, run by University College Cork at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian H Walsh (021 42020529, brianhenry.walsh@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce the age of CP diagnosis in Ireland. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.