Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT07189494
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 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.
* Written informed parental consent (Dutch, English, French, German, Italian, Spanish).
Exclusion Criteria:
* 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.
* Not being able to read one of the six Informed Consent languages.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
2 Years
Study:
NCT07189494
Study Brief:
Protocol Section:
NCT07189494