Overview

Inhaled Treatment for Bronchopulmonary Dysplasia

Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospitals Cleveland Medical Center
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