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.
Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
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)
Death prior to discharge from the neonatal unit (High-Risk Infants only)
No parental consent (High-Risk and Control Infants)
All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically: All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight All encephalopathic infants Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam) All full-term infants (\>37 weeks gestation), without requirement for admission to the NICU will be eligible to be enrolled in the study as the control arm of the study
Case-control
Prospective
Not listed
A
To characterise the development of neural architecture and function during sleep using EEG, from the near-term period to 4 months corrected gestational age for infants at elevated risk of cerebral palsy and diagnosed with cerebral palsy
B
To examine underlying neuro-specific protein profiles near term corrected gestational age as early biomarkers of altered neural function, motor and developmental outcomes in infants at elevated risk of cerebral palsy and diagnosed with cerebral palsy.
C
Develop novel measures of cognitive outcome, including executive function, and use these to compare trajectories in infants with cerebral palsy and those without, from 4 to 24 months
A
To optimise existing predictive machine learning algorithms
B
To develop and establish a standardised, early fixation classification assessment tool that can be used for infants at risk of cerebral palsy in high-risk follow-up clinics across Ireland
C
To investigate ophthalmological biomarkers, including morphology, as potential early predictors of cerebral palsy and cognitive outcomes
Click on the lead sponsor to view all of their trials.
University College Cork
Lead sponsor
Coombe Women and Infants University Hospital
Collaborator
The Rotunda Hospital
Collaborator
Cerebral Palsy Foundation
Collaborator
Karolinska Institutet
Collaborator
University of Pisa
Collaborator
Göteborg University
Collaborator
