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Completed

NCT Number: NCT02527798

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

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

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

7 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arkansas Children's Hospital/University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • < 29 weeks gestational age at birth
  • 7-28 days postnatal age at time of first study dose

Exclusion criteria

  • Exposure to any diuretic ≤ 72 hours prior to first study dose
  • Previous enrollment and dosing in current study, "Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia"
  • Hemodynamically significant patent ductus arteriosus, as determined by the investigator
  • Major congenital anomaly (e.g. congenital diaphragmatic hernia, congenital pulmonary adenomatoid malformation)
  • Meconium aspiration syndrome
  • Known allergy to any diuretic
  • Serum creatinine >1.7 mg/dL < 24 hours prior to first study dose
  • BUN >50 mg/dL < 24 hours prior to first study dose
  • Na <125 mmol/L < 24 hours prior to first study dose
  • K ≤2.5 mmol/L < 24 hours prior to first study dose
  • Ca ≤ 6 mg/dL < 24 hours prior to first study dose
  • Indirect bilirubin >10 mg/dL < 24 hours prior to first study dose
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Treatment and study plan

Furosemide Cohort 1

Drug

furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.

Other names: Lasix

Furosemide Cohort 2

Drug

furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.

Other names: Lasix

Furosemide Cohort 3

Drug

furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.

Other names: Lasix

Placebo

Other

Sugar water will be administered in a equivalent volume as drug intervention.

Other names: sugar water

Primary outcomes

  1. Safety as Determined by Adverse Events

    Time frame: 35 days for each participant

    Safety was assessed following the initial study-specific procedure (e.g., screening blood draws, dosing) through 7 days post last study dose by frequency and incidence of adverse events and serious adverse events.

Secondary outcomes

  1. Moderate-Severe BPD or Death Risk Throughout Weekly Treatment

    Time frame: Risk measured weekly through Week 4

    Moderate-severe BPD or death risk was defined by the NICHD Neonatal Research Network (NRN) BPD outcome estimator which provides an estimate of the risk of BPD (none, mild, moderate, severe) or death by postnatal day and is presented as a percentage. For this protocol, the categories were dichotomized to none-mild vs. moderate-severe-death. The risk of BPD or death was defined by the NICHD NRN BPD estimator on days 7, 14, 21 and 28 of study drug using the closest day available from the BPD estimator. The BPD estimator includes infants up to 28 postnatal days; for infants in this protocol older than that, 28-day estimates are used.

  2. Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined

    Time frame: 36 weeks postmenstrual age

    Moderate-severe BPD or death risk was defined using the NICHD Neonatal Research Network BPD outcome estimator.

  3. Clearance

    Time frame: After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.

    Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.

  4. Volume of Distribution

    Time frame: After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.

    Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.

  5. Half-life

    Time frame: After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.

    Data was collected from Furosemide/Active Cohort 1 and Cohort 2 and combined Cohorts. In total 39 active drug recipients participated. PK samples were collected after 7 days on study drug at recommended time points through 28 days on study drug plus one elimination (post drug discontinuation) time point.

  6. Area Under the Plasma Concentration Versus Time Curve

    Time frame: After study drug administration completion within 30 minutes, 2-4 hours, 6-8 hours, 12-16 hours, and 20-22 hours; within 30 minutes prior to the next dose; and within 48-72 hours of the final study drug administration.

    Population PK data were collected from the two Furosemide cohorts and includes all 39 active drug recipients.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Duke University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • The Emmes Company, LLC

Registry information

Official study title

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2015
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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