Assessing Intellectual and Motor Outcomes in High-risk Infants
NCT ID: NCT06857539
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2025-03-04
2029-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High-Risk Group
This group will have risk factors such as prematurity or hypoxic-ischaemic encephalopathy which put them in the High-Risk cohort
No interventions assigned to this group
Control Group
This group will be healthy, term infants who do not require admission to neonatal intensive care
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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)
All full term infants will be eligible if:
Term infants born \> 37 weeks gestational age
Not admitted to the NICU
No neurological impairments at birth (no identified congenital or genetic abnormalities)
Exclusion Criteria
Death prior to discharge from the neonatal unit (High-Risk Infants only)
No parental consent (High-Risk and Control Infants)
0 Days
4 Months
ALL
Yes
Sponsors
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Coombe Women and Infants University Hospital
OTHER
The Rotunda Hospital
OTHER
Cerebral Palsy Foundation
UNKNOWN
Karolinska Institutet
OTHER
University of Pisa
OTHER
Göteborg University
OTHER
University College Cork
OTHER
Responsible Party
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Dr. Deirdre Murray
Professor of Paediatrics
Principal Investigators
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Deirdre M Murray
Role: PRINCIPAL_INVESTIGATOR
INFANT Research Centre, University College Cork, Cork, Ireland
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Andreea Pavel
Role: backup
Brian H Walsh
Role: backup
Caroline Aherne
Role: backup
Eugene Dempsey
Role: backup
Eamonn O'Connell
Role: backup
Geraldine Boylan
Role: backup
Matilda Biba
Role: backup
Danielle Clifford
Role: backup
Mary Anne Ryan
Role: backup
Sean Mathieson
Role: backup
Eleanor Molloy
Role: backup
Denise McDonald
Role: backup
Breda Hayes
Role: backup
Afif El-Khuffash
Role: backup
Related Links
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Launch of Cerebral Palsy Research Programme at University College Cork
Inaugural lecture: Professor Deirdre Murray, CPF Chair in Early Brain Injury and Cerebral Palsy
Other Identifiers
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DM01
Identifier Type: -
Identifier Source: org_study_id
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