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:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT01619228
Eligibility Criteria:
Inclusion Criteria:
(1) Premature infants of gestational ages 24 to 36.9 weeks or healthy full term infants of gestational age ≥ 37 weeks (2) Premature infants who are patients in the Neonatal Intensive Care Unit of University Hospital (3) Healthy full term infants (who were born at University Hospital (4) Full term infants (≥ 37 weeks gestational age) who were transported to Cincinnati Children's Hospital Medical Center for care after birth (4) Free of congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 2 (5) Free of skin infections such as herpes simplex (6) Sufficiently medically stable such that study procedures can be tolerated (7) Parent/guardian willing to provide written informed consent for participation
Direct admit surgical subjects
Inclusion Criteria:
1. Premature infants of gestational ages 24 to 36.9 weeks
2. Full term infants ≥ 37 weeks gestational age
(2) Infant admitted directly to the Neonatal Intensive Care Unit of Cincinnati Childrens for surgical procedures after delivery (3) Free of congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis and trisomy 21 (5) Free of skin infections such as herpes simplex (4) Sufficiently medically stable such that study procedures can be tolerated (5) Parent/guardian willing to provide written informed consent for participation
Exclusion Criteria:
1. Gestational age \< 24 weeks
2. Have congenital conditions that affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 21
3. Have a skin infection such as herpes simplex
4. Judged to be medically unstable such that study procedures cannot be tolerated
5. Parent/guardian unwilling to provide written informed consent for participation.
Direct admit surgical subjects
Exclusion Criteria:
1. Infants ≥ 43 weeks gestational age
2. Have congenital conditions known to affect the skin such as epidermolysis bullosa, ichthyosis, trisomy 21
3. Have a skin infection such as herpes simplex
Adult subject controls:
Inclusion Criteria:
1. Parent of an infant enrolled in the study
2. Free from skin irritation, rash, scars, wounds or other skin damage in an area of at least 200 cm2 on one volar forearm
3. Able to come to the infant's hospital for study measurements on one day when infant measurements are made
4. Willing to provide written informed consent for participation
Exclusion Criteria:
(1) Not a parent of an infant enrolled in the study (2) Have skin irritation, rash, scars, wounds or other skin damage in an area of at least 200 cm2 on one volar forearm (3) Unable to come to the infant's hospital for study measurements on one day when infant measurements are made (4) Unwilling to provide written informed consent for participation
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
43 Weeks
Study:
NCT01619228
Study Brief:
Protocol Section:
NCT01619228