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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03503994
Eligibility Criteria:
Inclusion Criteria:
* Birth weight \< 1,250 grams
* Gestational age \< 32 weeks
* Need for assisted, invasive mechanical ventilation with at least the following settings:
ventilation rate \> 15 breaths per min, fractional oxygen concentration of inspired gas (FiO2) \> 30% but \< 60%)
* Postnatal age 10-21 days
* Stable ventilatory requirements over the 48-72 hours prior to enrollment
Exclusion Criteria:
* Actual or suspected sepsis
* Congenital cardiorespiratory malformation
* Patent ductus arteriosus
* Presence of necrotizing enterocolitis
* Presence of gastrointestinal hemorrhage or perforation
* Treatment with systemic dexamethasone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
4 Weeks
Study:
NCT03503994
Study Brief:
Protocol Section:
NCT03503994