Ensemble: European Newborn Study: Early Markers for a Better LifE II

Cerebral palsy (CP) is the most common cause of physical disability in children, but is still diagnosed too late. As a consequence, the great majority of children with CP do not get specific intervention until after their second birthday and this worsens their motor and cognitive outcomes as the great part of the entire neuroplastic window for motor learning is misspent. Specific and reliable tools for the early detection of infants with CP have been recently defined and are now part of the first International Clinical Practice Guidelines. Infants with perinatal risk factors for CP can reliably receive an early diagnosis of CP at <6 months using a combination of brain magnetic resonance imaging (MRI) and either the general movement assessment (GMA) and/or the Hammersmith infant neurological examination (HINE), depending on the age of the child. In addition, EEG is essential to define and monitor the level of brain maturation and seizures in high-risk newborns, thus contributing to outcome prediction. As cerebral palsy is a heterogeneous condition, it is critical to be able to formulate the functional prognosis of the child at a very young age, so clinicians and families are informed and can make informed decisions on treatment goals and (novel) interventions. Machine-learning holds promise to improve prediction of long-term motor and cognitive outcomes, but its value needs to be investigated in a large sample size to demonstrate its validity and its broad application in clinical practice.
The overarching goal of the ENSEMBLE II project is to improve the lives of children (at risk for) cerebral palsy and their families through partnership between researchers and families in Europe. We will investigate and implement identified diagnostic tools for early diagnosis and prediction of long-term outcomes in newborns at risk of cerebral palsy. More specifically, we will explore the role of early diagnostic tools through the following two primary aims. Aim 1: to improve health programs for the early detection of CP by implementing international clinical practice guidelines, thereby reducing age at diagnosis and age at referral to CP-specific early intervention programs to under age 6 months. Aim 2: to develop and evaluate a machine-learning prediction model of long term motor and cognitive outcomes, based on established clinical markers, including neonatal neuroimaging, neuromonitoring, and functional assessments. In addition to aims 1 and 2, as a key exploratory
Fondation Paralysie Cérébrale 4th of May 2021 Application form : Ensemble
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objective (Aim 3), we will study the impact of predicting CP on the parents’ psychological wellbeing and how they cope with their work, social relations, and their affected child’s siblings, as well as their ability to cope with the child’s problems (e.g., pain, crying, difficulty sleeping and eating) while working together in multidisciplinary team with rehabilitation services and parent/patient support organizations.
This 5-year project will be performed by a highly complementary EU consortium in partnership with families by establishing a Family Advisory Council (FAC). Our consortium consists of world-renowned experts in the field of neonatal neurology and infant development, with particular regard to the diagnostic methodologies explored in the project (i.e. Neuroimaging, Electrophysiology, General Movements and HINE). Most importantly, a comprehensive team of experts in machine learning, information technology and bioengineering are a key part of the consortium and will allow for the development of the machine-learning prediction model. Unique to our consortium is the synergy between world-leading clinical and fundamental research teams and the CATI Multicenter Neuroimaging Platform (https://cati-neuroimaging.com), which will allow us to introduce standardized MRI, EEG, behavioral assessments, and clinical characteristics throughout the EU. Also on the team are world-class experts with a strong track record of (integrated) knowledge translation and patient- oriented research to bring guidelines and new knowledge directly to the people who can implement them – families, service providers, program and policy-maker leaders.