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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07303569
Eligibility Criteria:
Inclusion Criteria:
Phase 1
HCP participants:
1. Experts (e.g. tissue viability practitioners, dermatologist)
2. HCP looking after hospitalised infants and CYP
3. Able to give consent
Parent/ guardian participants:
1. Parents/ guardians of infants and CYP admitted to hospital with or developed PI
2. Parent/ guardian of a CYP under 19 years of age with dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.
3. Able to give consent
CYP participants:
1. Age 10 - 19
2. Dark skin tone according to Fitzpatrick Classification of Skin Types III, IV, V or VI.
3. Able to gain consent
4. Able to provide assent with parental consent
5. Developed PI during hospitalisation Phase 2 Hospitalised infants and CYP participants
1\. Infants and CYP admitted to hospital for 24 hrs 2. Age 0-19 years 3. Able to gain consent. 4. Fitzpatrick Classification of Skin Types IV, V or VI.
Exclusion Criteria:
Phase1:
HCP participants:
1. HCP not working with hospitalised infants and CYP.
2. Unable to provide consent.
Parents participants:
1. Parents of hospitalised infants and CYP with no PI.
2. Unable to gain consent
CYP participants:
1. Not able to provide consent
2. CYP with no PI during hospitalisation period Phase 2
1\. Admitted to hospital for less than 24 hrs 2. Unable to gain consent 3. Fitzpatrick Classification of Skin Types I, II or III
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07303569
Study Brief:
Protocol Section:
NCT07303569