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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01274260
Eligibility Criteria:
Inclusion Criteria:
1. Between 1 month and 18 years of age; AND
2. Admitted to the PICU with a diagnosis of ALI or ARDS, as defined by:
1. acute onset of the disease,
2. PaO2/FiO2 ratio \<300,
3. evidence of bilateral infiltrates on chest radiography, and
4. no evidence of cardiac dysfunction; AND
3. Intubated and mechanically ventilated.
Exclusion Criteria:
1. Underlying disease requiring steroids \>0.5mg/kg/day of methylprednisolone (eg. Asthma)
2. HIV positive, or have any other congenital or acquired immunodeficiency;
3. Terminally ill patients or patients on hospice care or if there is a lack of commitment to aggressive intensive care
4. Cytotoxic therapy within the past 3 weeks
5. Major gastrointestinal bleeding within last 1 month
6. Extensive burns (\>20% total body surface area of full- or partial-thickness burns)
7. Known or suspected adrenal insufficiency
8. Vasculitis or diffuse alveolar hemorrhage
9. Bone marrow or lung transplant
10. Disseminated fungal infections
11. Severe chronic liver disease
12. Other conditions with estimated 6-month mortality of 50% or higher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT01274260
Study Brief:
Protocol Section:
NCT01274260