Clinical trial NCT06857539: Assessing Intellectual and Motor Outcomes in High-risk Infants
Official title: The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy
Cerebral Palsy (CP)
Cerebral Palsy Children
High-risk Infants
Intellectual and Developmental Disabilities
Motor Impairment
Cognitive Development
Keywords: Cerebral Palsy
High-Risk Infant Follow-up
Motor Difficulty
Intellectual Delay
Cognitive Impairment
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: Coombe Women and Infants University Hospital
name: The Rotunda Hospital
name: Cerebral Palsy Foundation
name: Karolinska Institutet
name: University of Pisa
name: Göteborg University
First posted: 2025-03-04
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


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)

Primary outcomes:
measure: A
timeFrame: From near term to 4 months corrected gestational age
measure: B
timeFrame: Birth to 6 weeks
measure: C
timeFrame: 4 to 24 months
Secondary outcomes:
measure: A
timeFrame: During the study period, ie. over five years
measure: B
timeFrame: 4 months
measure: C
timeFrame: 18 months
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
city: Cork
country: Ireland
facility: INFANT Centre, University College Cork
city: Dublin
country: Ireland
facility: Coombe Women and Infant's Hospital
city: Dublin
country: Ireland
facility: The Rotunda Hospital
Study officials:
affiliation: INFANT Research Centre, University College Cork, Cork, Ireland
name: Deirdre M Murray
role: PRINCIPAL_INVESTIGATOR
References: