NCT06857539

Assessing Intellectual and Motor Outcomes in High-risk Infants

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 0 Days – 4 Months
• Healthy volunteers: Accepted

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. 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 Science Foundation Ireland (SFI) and the Cerebral Palsy Foundation, USA.

Conditions

• Cerebral Palsy
• Cerebral Palsy (CP)
• Cerebral Palsy Children
• High-risk Infants
• Intellectual and Developmental Disabilities
• Motor Impairment
• Cognitive Development

Timeline

• Start date: 2025-03-04
• Primary completion: 2029-07-31
• Completion: 2029-07-31
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

4 sites across 1 country: Ireland