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Assessing Intellectual and Motor Outcomes in High-risk Infants

Recruitingn/aAges 0 Days - 4 MonthsAllUniversity College Cork
NCT06857539 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

4 sites
Cork University Maternity Hospital
Cork, Ireland
INFANT Centre, University College Cork
Cork, Ireland
Coombe Women and Infant's Hospital
Dublin, Ireland
The Rotunda Hospital
Dublin, Ireland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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