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| Name | Class |
|---|---|
| Fondation Paralysie Cérébrale | OTHER |
| Zoundream | UNKNOWN |
| CP Nederland | UNKNOWN |
| NeuroSpin |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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 high risk for CP, thus with involvement of the corticospinal tracts, cortex, white matter and basal ganglia (Wagenaar et al., 2018).
Presence of other brain injuries with expected adverse motor outcome (i.e. big subdural and parenchymal bleedings with/without midline shift, bilirubin induced brain injury) in preterm infants, term infants with neonatal encephalopathy with/without neonatal seizures.
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Parent experience asked in questionnaires at age 3-4 months and 2 years. |
| University Hospital Essen | Recruiting | Essen | Germany |
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| Ospedale Pediatrico Meyer Firenze | Recruiting | Florence | Italy |
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| Istituto Giannina Gaslini | Not yet recruiting | Genova | Italy |
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| Ospedale Maggiore di Milano | Recruiting | Milan | Italy |
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| Fondazione Stella Maris | Recruiting | Pisa | Italy |
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| UMC Utrecht | Recruiting | Utrecht | Netherlands |
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| University Hospital La Paz | Recruiting | Madrid | Spain |
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