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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT06396520
Eligibility Criteria:
Inclusion Criteria High-Risk population:
Group: 'Newborn-detectable risk-pathway'
* Preterm birth with gestational age below 32 weeks
* Birth weight below 1500 g
* Moderate to severe brain injury (A label of moderate to severe brain injury was considered if there was Papile grade three to four intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition)
* History (e.g., neonatal seizures, ECMO, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (malformations in CNS, increased tone)
Group: 'Infant detectable risk-pathway'
* Inability to sit independently by age 9 months
* Hand function asymmetry or crawl asymmetry
* Inability to take weight through the plantar surface of the feet
* History (e.g., as above) or neurological risk factors
Additional inclusion criteria for inclusion in NIBS-CP for both CP-risk groups:
\- Consent to health-relevant information on clinical findings being passed on to the medical doctors in CP-EDIT and/or their primary care physician.
Inclusion Criteria Typically developing infant population:
* Born \>37 weeks
* Uneventful birth
* No known history of brain injury
* No neurological condition
* Consent to health-relevant information on clinical findings being passed on to their primary care physician or relevant medical doctors, e.g., neuropaediatrician.
Exclusion Criteria (all groups):
* Infants have any MRI contraindications, e.g., pacemaker or other implanted electronic devices.
* Families do not speak or understand Danish.
* Families do not wish to be informed about incidental findings on the MRI, or scores within the clinical range in the neurological, motor, or cognitive assessments.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
11 Months
Study:
NCT06396520
Study Brief:
Protocol Section:
NCT06396520