Actively Recruiting

Age: 0Days - 4Months
All Genders
Healthy Volunteers
NCT06857539

Assessing Intellectual and Motor Outcomes in High-risk Infants

Led by University College Cork · Updated on 2026-05-13

600

Participants Needed

4

Research Sites

279 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

C

Coombe Women and Infants University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Assessing Intellectual and Motor Outcomes in High-risk Infants

Who Can Participate

Age: 0Days - 4Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Legal guardians must be able and willing to give written informed consent and comply with study requirements
  • Infants considered high risk for cerebral palsy or neuro-developmental impairment
  • Preterm infants born at or before 32 weeks post menstrual age or weighing 1500 grams or less
  • Encephalopathic infants
  • Infants with neurological risk factors such as brain defects, injury, or abnormal neurological exams
  • Control group infants also recruited
Not Eligible

You will not qualify if you...

  • Death before discharge from the neonatal unit (for high-risk infants)
  • No parental consent for participation (for both high-risk and control infants)

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Cork University Maternity Hospital

Cork, Ireland

Actively Recruiting

2

INFANT Centre, University College Cork

Cork, Ireland

Actively Recruiting

3

Coombe Women and Infant's Hospital

Dublin, Ireland

Not Yet Recruiting

4

The Rotunda Hospital

Dublin, Ireland

Actively Recruiting

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Research Team

D

Deirdre Murray Principal Investigator

CONTACT

D

Danielle Clifford

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Assessing Intellectual and Motor Outcomes in High-risk Infants | DecenTrialz