Assessing Intellectual and Motor Outcomes in High-risk Infants

Официальное название

The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy

Обзор

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.

Первичные конечные точки

• A [Срок оценки: From near term to 4 months corrected gestational age]
• B [Срок оценки: Birth to 6 weeks]
• C [Срок оценки: 4 to 24 months]

Вторичные конечные точки (3)

• A [Срок оценки: During the study period, ie. over five years]
• B [Срок оценки: 4 months]
• C [Срок оценки: 18 months]

Критерии участия

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.

Критерии исключения

• Death prior to discharge from the neonatal unit (High-Risk Infants only)
• No parental consent (High-Risk and Control Infants)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Ирландия · 4 центра

• Cork University Maternity Hospital — Cork
• INFANT Centre, University College Cork — Cork
• Coombe Women and Infant's Hospital — Dublin
• The Rotunda Hospital — Dublin

Идентификаторы

NCT: NCT06857539 · DM01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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