Brief Title
Inhaled Treatment for Bronchopulmonary Dysplasia
Official Title
Pilot Study of an Inhaled Treatment for Bronchopulmonary Dysplasia
Brief Summary
The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia
Detailed Description
Open label study with 20 participants, with block dose escalation (3 patients each at 2, 5, 10, 15, 20 part-per-million, 5 additional patients at 20 ppm or next highest safe dose). The primary outcomes are safety during 4 hours of inhalation (including measures of methemoglobin and ethanol byproducts) and 7 day adverse events
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Treatment Emergent Adverse Events
Secondary Outcome
S-nitrosoglutathione change
Condition
Bronchopulmonary Dysplasia
Intervention
SNO agent
Study Arms / Comparison Groups
SNO therapy
Description: Intervention will be 4 hours of inhaled SNO agent in enrollment blocks of three subjects/dose (2, 5, 10, 15, 20ppm) to infants.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
March 1, 2021
Completion Date
April 1, 2023
Primary Completion Date
March 1, 2023
Eligibility Criteria
Inclusion Criteria: - Inborn or outborn infants of either sex or any race or ethnicity - <32 weeks gestation at birth (best obstetrical dating) - Aged 29 to 365 days - Requires respiratory support from a ventilator - Average oxygen requirement >35% x 5 days preceding enrollment - Informed consent signed and dated by parent and/or guardian Exclusion Criteria: - Life-threatening congenital or acquired anomalies (lethal chromosomal, thoracic/cardiac, brain) - Unstable condition defined as severe hypoxemia (FiO2 >85% for >24hrs), sepsis, or hypotension - Baseline methemoglobin > 3% - On steroid to facilitate endotracheal extubation - Thrombocytopenia defined as <50,000 platelets/µL on weekly NICU labs or clinical evidence of bleeding - Anemia defined as a hemoglobin of < 9 mg/dL on weekly NICU labs - Concerns for pre-existing liver damage defined as an AST/ALT > 50 IU/L or direct bilirubin >1 mg/dL on weekly NICU labs - 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 - Patients that are ventilated with a device not certified for blending of other medical gases into the ventilator circuit - 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 - Subjects that have experienced cardiac arrest with CPR for longer than 30 minutes
Gender
All
Ages
N/A - 365 Days
Accepts Healthy Volunteers
No
Contacts
Thomas Raffay, MD, (216)844-3387, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04619602
Organization ID
BPD
Responsible Party
Principal Investigator
Study Sponsor
University Hospitals Cleveland Medical Center
Study Sponsor
Thomas Raffay, MD, Principal Investigator, University Hospitals Cleveland Medical Center
Verification Date
November 2020