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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT04619602
Eligibility Criteria:
Inclusion Criteria:
1. Inborn or outborn infants of either sex or any race or ethnicity
2. \<32 weeks gestation at birth (best obstetrical dating)
3. Aged 29 to 365 days
4. Refractory hypoxic respiratory failure (average daily FiO2 \>35% for 5 days)
5. Requires mechanical ventilation via endotracheal airway
Exclusion Criteria:
1. Life-threatening congenital or acquired anomalies (lethal chromosomal, thoracic/cardiac, brain)
2. Unstable condition defined as severe hypoxemia (FiO2 \>85% for \>24hrs), sepsis, or hypotension
3. Baseline methemoglobin \> 3%, congenital methemoglobinemia, or a familial hemoglobinopathy
4. On steroid to facilitate endotracheal extubation
5. Individuals on inhaled nitric oxide, a phosphodiesterase 5 (PDE-5) inhibitor, taking allopurinol, β-adrenergic blockers, tricyclic antidepressants, meperidine (or related CNS agents), or nitrates
6. Thrombocytopenia defined as \<50,000 platelets/µL on weekly NICU labs, clinical evidence of bleeding, on an anti-coagulant, or individuals with an inherited or acquired coagulation disorder
7. Anemia defined as a hemoglobin of \< 9 mg/dL on weekly NICU labs
8. Concerns for pre-existing liver damage defined as an AST/ALT \> 50 IU/L or direct bilirubin \>1 mg/dL on weekly NICU labs
9. Concerns for acute kidney injury defined as a serum creatinine \> 0.7 mg/dL on weekly NICU labs or 24-hr urine output \<1.0 ml/kg/hr during preceding 4 days
10. Patients that are ventilated with a device not certified for blending of aerosolized solutions into the ventilator circuit
11. Physician of record opposed to enrolling the patient due to perceived safety concerns; or any condition that does not allow the protocol to be followed safely
12. Subjects that have experienced cardiac arrest with CPR for longer than 30 minutes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
29 Days
Maximum Age:
365 Days
Study:
NCT04619602
Study Brief:
Protocol Section:
NCT04619602