Inhaled Treatment for Bronchopulmonary Dysplasia

Phase 1

Suspended

• Conditions: Bronchopulmonary Dysplasia

• Registration Number: NCT04619602
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events

Secondary Outcome Measures

Name	Time	Method
S-nitrosoglutathione change;Change in oxygen saturation index;Change in GSNO catabolism pre/post treatment;Intermittent hypoxemia as measured by oxygen saturation post treatment;Ventilator parameters post treatment