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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03120702
Eligibility Criteria:
Inclusion Criteria:
* Male or female newborn infants of any gestational age requiring at least one (1) blood draw as part of their routine care.
* Ages: Newborn infants less than 16 weeks postnatal age.
* Weight: Range from 500 g to 10 kg.
* Able to obtain written informed consent from parents or legal guardians
Exclusion Criteria:
* Neonatal patients with abnormalities at the planned application sites that would interfere with transilluminating the foot or hand like unusual deformities of limbs, absence of feet, severe edema, localized infections, and other.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
16 Weeks
Study:
NCT03120702
Study Brief:
Protocol Section:
NCT03120702