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 Information
Recruitment Status
Drug
Estimated Enrollment
120
Start Date
November 27, 2015
Completion Date
December 15, 2021
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
Administrative Informations
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
February 2021