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:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
NCT ID:
NCT05048550
Eligibility Criteria:
Inclusion criteria:
1. All term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE).
2. All preterm infants born at \<29 weeks gestational age.
Specifically, all children fulfilling these criteria will be eligible. Evidence of hypo-accommodation is not required.
Exclusion criteria:
1. Infants that are still an inpatient at 8 weeks corrected gestational age.
2. Ocular exclusion criteria: children with unrelated congenital or developmental ocular abnormality such as cataract requiring surgery, genetic retinal disease, coloboma. Retinopathy of prematurity will not be an exclusion criterion.
3. Infants with high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
8 Weeks
Study:
NCT05048550
Study Brief:
Protocol Section:
NCT05048550