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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
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