European Newborn Study: Early Markers for a Better LifE
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-2
Sponsordr. M.J.N.L. Benders
About this trial
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents.
Parents of participants will:
\- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.
For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All infants with confirmed brain injury on MRI at high risk for CP.
Extensive punctate white matter injury.
Periventricular hemorrhagic infarction (any location).
Cerebellar injury (ischemic and/or hemorrhages) involving the vermis or involving more than 1/3 of the cerebellar hemisphere and/or lesions involving the cerebellar vermis (Meijler & Steggerda, 2019).
Disqualifiers
Infants not matching the inclusion criteria.
Any proven or suspected severe congenital anomaly, genetic or metabolic disorder.
Presence of an infection of the central nervous system.
Parents < 18 years old.
Trial population
The study population will include all preterm and term born infants with any brain injury at risk for CP admitted to the neonatal intensive of 8 large European NICUs, high and medium care units, including their parents. Based on a conservative estimate and taking into account incidence of in/exclusion criteria, we expect to include 1000 eligible patients in a total inclusion period of 2.5 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Development of a machine learning based prediction model
To develop and evaluate a new prediction model using machine learning to predict the risk, severity, and long-term outcome of cerebral palsy (CP) at the level of the individual patient. This model will also provide automatic scoring for each clinical modality (MRI, EEG, GM, HINE, infant cry), which is to be compared with the clinician assessments.
Time frame
Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected ageSecondary outcomes
1
Gaining insight into parental mental well-being and family= and social functioning.
To gain insight in parental mental well-being and family- and social functioning, over the first two years after the birth of their child with brain injury, born preterm or full-term, at high risk of developing CP. Including evaluation of parents' experiences around the disclosure of diagnosis, and the impact of these experiences, child-related factors and social support on parental mental well-being. To understand the needs and preferences of parents on the process of disclosure of diagnosis and on information regarding prediction and prognosis, and to identify what information is meaningful to families.
Time frame
Parent experience asked in questionnaires at age 3-4 months and 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
dr. M.J.N.L. Benders
Lead sponsor
UMC Utrecht
Sponsor institution
Fondation Paralysie Cérébrale
Collaborator
Zoundream
Collaborator
CP Nederland
Collaborator
NeuroSpin
Collaborator
Source ClinicalTrials.gov