Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)

Brief Title

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)

Official Title

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

Brief Summary

      This study will describe the safety of furosemide in premature infants at risk of
      bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics
      (PK) of furosemide. Funding Source - FDA OOPD
    

Detailed Description

      Infants will receive a placebo or furosemide for 28 days. Blood samples will be collected for
      pharmacokinetic analysis.Premature infants will be randomized to receive placebo or
      furosemide in a dose escalating approach.

      Follow up information will be collected up to 7 days after the last dose and at 36 weeks post
      menstrual age. The final study assessment will occur at the time of discharge, early
      termination or transfer.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Safety as determined by adverse event experienced by participants. Description of safety of furosemide in premature infants at risk of BPD

Secondary Outcome

 Change in moderate-severe BPD or death risk from baseline

Condition

Bronchopulmonary Dysplasia

Intervention

Furosemide Cohort 1

Study Arms / Comparison Groups

 Furosemide Cohort 1

Description:  Within cohort 1, infants will be randomized using a 3:1 scheme to receive furosemide or placebo. Those randomized to receive furosemide will receive (1mg/kg daily intravenously or 2 mg/kg daily enterally for 28 days.

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

120

Start Date

November 27, 2015

Completion Date

December 15, 2020

Primary Completion Date

October 15, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Receiving positive airway pressure (nasal continuous airway pressure, nasal
             intermittent positive pressure ventilation, or nasal cannula flow > 1LPM) or
             mechanical ventilation (high frequency or conventional)

          2. < 29 weeks gestational age at birth

          3. 7-28 days postnatal age at time of first study dose

        Exclusion Criteria:

          1. Exposure to any diuretic ≤ 72 hours prior to first study dose

          2. Previous enrollment and dosing in current study, "Safety of Furosemide in Premature
             Infants at Risk of Bronchopulmonary Dysplasia"

          3. Hemodynamically significant patent ductus arteriosus, as determined by the
             investigator

          4. Major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary
             adenomatoid malformation)

          5. Meconium aspiration syndrome

          6. Known allergy to any diuretic

          7. Serum creatinine >1.7 mg/dL < 24 hours prior to first study dose

          8. BUN >50 mg/dL < 24 hours prior to first study dose

          9. Na <125 mmol/L < 24 hours prior to first study dose

         10. K ≤2.5 mmol/L < 24 hours prior to first study dose

         11. Ca ≤ 6 mg/dL < 24 hours prior to first study dose

         12. Indirect bilirubin >10 mg/dL < 24 hours prior to first study dose

         13. Any condition which would make the participant, in the opinion of the investigator,
             unsuitable for the study
      

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

Jason E Lang, MD, MPH, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02527798

Organization ID

15-1978

Secondary IDs

HHSN27500033

Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill

Collaborators

 Duke University

Study Sponsor

Jason E Lang, MD, MPH, Study Chair, Duke University

Verification Date

August 2020