Assessing Intellectual and Motor Outcomes in High-risk Infants

NCT06857539 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy
  • Cerebral Palsy (CP)
  • Cerebral Palsy Children
  • High-risk Infants
  • Intellectual and Developmental Disabilities
  • Motor Impairment
  • Cognitive Development
  • HIE - Hypoxic - Ischemic Encephalopathy
  • Preterm
  • Prematurity; Extreme

Sponsors & Collaborators

  • Coombe Women and Infants University Hospital

    collaborator OTHER
  • The Rotunda Hospital

    collaborator OTHER
  • Cerebral Palsy Foundation

    collaborator UNKNOWN
  • Karolinska Institutet

    collaborator OTHER
  • University of Pisa

    collaborator OTHER
  • Göteborg University

    collaborator OTHER
  • University College Cork

    lead OTHER

Principal Investigators

  • Deirdre M Murray · INFANT Research Centre, University College Cork, Cork, Ireland

Eligibility

Min Age
0 Days
Max Age
4 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-21
Primary Completion
2030-07-31
Completion
2030-07-31

Countries

  • Ireland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857539 on ClinicalTrials.gov