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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT02774434
Eligibility Criteria:
Inclusion Criteria:
* The subject is a neonate ≥24 weeks of gestational age for whom a course of phototherapy has not started, is in progress or has been completed
* The subject's routine management includes TSB evaluations
* The subject's family are willing and able to participate in baseline and TSB measurements over 10 days
* Written informed consent to participate in the study has been provided by the subject or legal representative (parent or legal guardian in a clinical study involving children)
Exclusion Criteria:
* The subject has Hydrops fetalis
* The subject has major congenital malformations, diseases or skin conditions or thickness that, in the opinion of the investigator would preclude or interfere with the use of the JM-105
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
40 Weeks
Study:
NCT02774434
Study Brief:
Protocol Section:
NCT02774434