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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT05558059
Eligibility Criteria:
Inclusion Criteria:
* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
* Parent/Legal Guardian is able and willing to consent to study participation for the infant
* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit
Exclusion Criteria:
* Participant or Parent/Legal Guardian unwilling or unable to provide consent
* Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)
* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
2 Months
Study:
NCT05558059
Study Brief:
Protocol Section:
NCT05558059