NCT06857539 Assessing Intellectual and Motor Outcomes in High-risk Infants
| NCT ID | NCT06857539 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Cork |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-03-21 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria (High Risk Group) : * 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. Exclusion Criteria: * Death prior to discharge from the neonatal unit (High-Risk Infants only) * No parental consent (High-Risk and Control Infants)
Contact & Investigator
Deirdre M Murray
PRINCIPAL INVESTIGATOR
INFANT Research Centre, University College Cork, Cork, Ireland
Frequently Asked Questions
Who can join the NCT06857539 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 4 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06857539 currently recruiting?
Yes, NCT06857539 is actively recruiting participants. Contact the research team at d.murray@ucc.ie for enrollment information.
Where is the NCT06857539 trial being conducted?
This trial is being conducted at Cork, Ireland, Cork, Ireland, Dublin, Ireland, Dublin, Ireland.
Who is sponsoring the NCT06857539 clinical trial?
NCT06857539 is sponsored by University College Cork. The principal investigator is Deirdre M Murray at INFANT Research Centre, University College Cork, Cork, Ireland. The trial plans to enroll 600 participants.
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