Cerebral Palsy Clinical Trials

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The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
SUMMARY

Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP. In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 4 months
Healthy Volunteers: t
View:

⁃ 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 a diagnosis of 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., cerebral birth defect, injury/malformation on neuroimaging, persistently abnormal neurological exam)

• (Control Group)

• A control arm will also be recruited.

Locations
Other Locations
Ireland
Cork University Maternity Hospital
RECRUITING
Cork
INFANT Centre, University College Cork
RECRUITING
Cork
Coombe Women and Infant's Hospital
NOT_YET_RECRUITING
Dublin
The Rotunda Hospital
RECRUITING
Dublin
Contact Information
Primary
Deirdre Murray Principal Investigator
d.murray@ucc.ie
+353 021 420 5082
Backup
Danielle Clifford
dclifford@ucc.ie
+353 021 420 5082
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 600
Treatments
High-Risk Group
This group will have risk factors such as prematurity or hypoxic-ischaemic encephalopathy which put them in the High-Risk cohort
Control Group
This group will be healthy, term infants who do not require admission to neonatal intensive care
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska Institutet, Coombe Women and Infants University Hospital, University of Pisa, Cerebral Palsy Foundation, Göteborg University, The Rotunda Hospital
Leads: University College Cork

This content was sourced from clinicaltrials.gov