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Search / Trial NCT06857539

Assessing Intellectual and Motor Outcomes in High-risk Infants

Launched by UNIVERSITY COLLEGE CORK · Feb 26, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

Cerebral Palsy High Risk Infant Follow Up Motor Difficulty Intellectual Delay Cognitive Impairment

ClinConnect Summary

This clinical trial is studying how to improve the diagnosis of cerebral palsy (CP) in babies who are at high risk of developing this condition. Cerebral palsy affects movement and muscle control and can sometimes lead to learning difficulties. Many babies who are considered at higher risk, like those born prematurely or with certain brain injuries, may not actually develop CP, but it can take a long time—up to 2 years—to find out for sure. The goal of this study is to use new tests to help identify those who may develop CP earlier, so they can receive the support they need sooner.

To participate, babies must be in the high-risk category, which includes those born very early (before 32 weeks) or with specific brain concerns. The study is open to all infants, including those born full term who have no early health issues. Participants will be followed in clinics at several hospitals in Ireland, and the study will involve assessments to better understand their motor and cognitive development. This research is important because it aims to provide quicker diagnoses and better outcomes for children at risk of CP.

Gender

ALL

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)
  • 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:
  • - (High Risk \& Control Groups)
  • Death prior to discharge from the neonatal unit (High-Risk Infants only)
  • No parental consent (High-Risk and Control Infants)

About University College Cork

University College Cork (UCC) is a leading research institution located in Ireland, renowned for its commitment to advancing healthcare through innovative clinical research. The university's clinical trial unit is dedicated to conducting high-quality, ethically sound studies that aim to improve patient outcomes and contribute to the scientific understanding of various medical conditions. UCC collaborates with a diverse network of healthcare professionals, researchers, and industry partners to facilitate pioneering trials across multiple therapeutic areas, ensuring adherence to the highest standards of regulatory compliance and patient safety. Through its initiatives, UCC strives to foster advancements in medicine and enhance the overall health of communities both locally and globally.

Locations

Cork, , Ireland

Dublin, , Ireland

Cork, , Ireland

Dublin, , Ireland

Patients applied

0 patients applied

Trial Officials

Deirdre M Murray

Principal Investigator

INFANT Research Centre, University College Cork, Cork, Ireland

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported