Inhaled Treatment for Bronchopulmonary Dysplasia

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 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

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