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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT05461404
Eligibility Criteria:
Inclusion Criteria:
* infants \<72 hours of age
* weigh 700-1500 at birth
* hospitalized at SMCH
Exclusion Criteria:
* infants who are moribund and highly likely not to survive despite any intervention
* significant breaches in their skin barrier
* conditions indicating failure to gain weight
* critically ill (definition below):
1. Oxygen saturation \<88% on oxygen therapy AND ≥2 of the following conditions:
2. respiratory rate \<20 or \>100 breaths per minute
3. apnea requiring bag-mask ventilation
4. heart rate \<100 or \>200 beats per minute
* congenital syphilis
* hydrops fetalis
* a life-threatening congenital anomaly or major surgical condition requiring intervention
* generalized skin disease or a structural defect involving \>5% body surface area likely to produce a defect in epidermal barrier function
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
28 Days
Study:
NCT05461404
Study Brief:
Protocol Section:
NCT05461404