Assessing Intellectual and Motor Outcomes in High-risk Infants

Not yet recruiting

• Conditions: Cerebral Palsy; Cerebral Palsy (CP); Cerebral Palsy Children; High-risk Infants; Intellectual and Developmental Disabilities; Motor Impairment; Cognitive Development

• Registration Number: NCT06857539
• Lead Sponsor: University College Cork

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study Start: 2025-03-04
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2029-07-31
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

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