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 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT01131403
Eligibility Criteria:
Inclusion Criteria:
* All healthy (i.e. meeting none of the non-inclusion criteria) term newborns are possible candidates for the study. The following criteria must be met for enrollment in the study:
1. Male and female term newborns from 37 completed weeks of gestation, age ≤ 48 hours
2. Written informed parental consent
Exclusion Criteria:
* Any critically ill term newborn, i.e. septic infants, infants born with serious congenital malformation/defects, asphyxia, hydronephrosis, severe intracranial hemorrhage
* Newborns with known immunodeficiency
* Newborns with pre-existing skin disease with eruptions covering more than 50% of body surface i.e. congenital ichthyosis, congenital candidiasis
* Newborn has relevant skin maceration, which influence the measurements or is communicable i.e. urticaria or herpes
* Any acutely or chronically ill newborn with temperatures below 35°C or above 40°C
* Newborn is taking part in another study or is during a term of exclusion of a study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
48 Hours
Study:
NCT01131403
Study Brief:
Protocol Section:
NCT01131403