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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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.

Detailed Summary:

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.


Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: Safety as determined by adverse event experienced by participants. Description of safety of furosemide in premature infants at risk of BPD [ Time Frame: 35 days for each participant ]

Safety will be assessed following initial study-specific procedure e.g., screening blood draws, dosing through 7 days post last study dose and it will be assessed by frequency and incidence of adverse events and serious adverse events. A safety monitoring committee (DMC) will be convened by NIH to review data and safety information from study participants throughout the study and prior to dose escalation into cohorts 2 and 3.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in moderate-severe BPD or death risk from baseline [ Time Frame: 36 weeks postmenstrual age ]
    Moderate-severe BPD or death risk will be defined by the NICHD Neonatal Research Network BPD outcome estimator. (https://neonatal.rti.org/index.cfm?fuseaction=BPDCalculator.start).
  • Clearance [ Time Frame: 6 Hr dosing: within 30 min, 2-4 hrs post dose, 12-18 hrs post last dose, within 30 min. prior to next dose. 24 hr dosing: within 30 min., 2-4 , 6-8, 12-16, 20-22 hrs post dose, 48-72 hrs post last dose and within 30 min before next dose ]
  • Volume of distribution [ Time Frame: 6 Hr dosing: within 30 min, 2-4 hrs post dose, 12-18 hrs post last dose, within 30 min. prior to next dose. 24 hr dosing: within 30 min., 2-4 , 6-8, 12-16, 20-22 hrs post dose, 48-72 hrs post last dose and within 30 min before next dose ]
  • Half life [ Time Frame: 6 Hr dosing: within 30 min, 2-4 hrs post dose, 12-18 hrs post last dose, within 30 min. prior to next dose. 24 hr dosing: within 30 min., 2-4 , 6-8, 12-16, 20-22 hrs post dose, 48-72 hrs post last dose and within 30 min before next dose ]
  • Area under the plasma concentration versus time curve (AUC) of furosemide [ Time Frame: 6 Hr dosing: within 30 min, 2-4 hrs post dose, 12-18 hrs post last dose, within 30 min. prior to next dose. 24 hr dosing: within 30 min., 2-4 , 6-8, 12-16, 20-22 hrs post dose, 48-72 hrs post last dose and within 30 min before next dose ]
  • Maximum concentration Peak Plasma Concentration (Cmax) of furosemide [ Time Frame: 6 Hr dosing: within 30 min, 2-4 hrs post dose, 12-18 hrs post last dose, within 30 min. prior to next dose. 24 hr dosing: within 30 min., 2-4 , 6-8, 12-16, 20-22 hrs post dose, 48-72 hrs post last dose and within 30 min before next dose ]


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: August 4, 2015
Date Started: August 2015
Date Completion: June 2020
Last Updated: May 3, 2017
Last Verified: May 2017