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Recruiting NCT07189494

European Newborn Study: Early Markers for a Better LifE

Trial Parameters

Condition Cerebral Palsy
Sponsor dr. M.J.N.L. Benders
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 0 Years
Max Age 2 Years
Start Date 2023-10-06
Completion 2029-01-01

Brief Summary

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

Inclusion Criteria: * All infants with confirmed brain injury on MRI at high risk for CP. Particularly, infants with the following brain injuries at risk for CP will be considered on MRI at term equivalent age or within 10 days after birth or sentinel event: * 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). * Cystic periventricular leukomalacia (grade 3 \& 4). * intraventricular hemorrhages grade III. * Posthemorrhagic ventricular dilatation exceeding the 97°percentile + 4mm for the ventricular index (Cizmeci et al., 2020). * Perinatal asphyxia with hypoxic ischemic injury of the central gray matter and/or perirolandic area. * Perinatal asphyxia with hypoxic ischemic injury in the watershed areas. * Perinatal ischemic arterial stroke at

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