Assessing Intellectual and Motor Outcomes in High-risk Infants (AIM-High)

University College Cork (UCC)

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06857539

DM01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: Under 4 months old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

600 participants in 2 patient groups

High-Risk Group

Description:

This group will have risk factors such as prematurity or hypoxic-ischaemic encephalopathy which put them in the High-Risk cohort

Control Group

Description:

This group will be healthy, term infants who do not require admission to neonatal intensive care