Cerebral Palsy, Cerebral Palsy Children, Cerebral Palsy (CP), Cognitive Development, HIE - Hypoxic - Ischemic Encephalopathy, High-risk Infants, Intellectual and Developmental Disabilities, Motor Impairment, Prematurity; Extreme, Preterm
Conditions
Keywords
Cerebral Palsy, High-Risk Infant Follow-up, Motor Difficulty, Intellectual Delay, Cognitive Impairment, Hypoxic--Ischaemic Encephalopathy, Prematurity
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.
Interventions
None listed
Sponsors
University College Cork
Coombe Women and Infants University Hospital
The Rotunda Hospital
Cerebral Palsy Foundation
Karolinska Institutet
University of Pisa
Göteborg University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 4 Months
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A | From near term to 4 months corrected gestational age | 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 | Birth to 6 weeks | 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 | 4 to 24 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A | During the study period, ie. over five years | To optimise existing predictive machine learning algorithms |
| B | 4 months | 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 | 18 months | To investigate ophthalmological biomarkers, including morphology, as potential early predictors of cerebral palsy and cognitive outcomes |
Countries
Ireland
Contacts
CONTACTDeirdre Murray Principal Investigator
CONTACTDanielle Clifford
PRINCIPAL_INVESTIGATORDeirdre M Murray
INFANT Research Centre, University College Cork, Cork, Ireland
Outcome results
None listed