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

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia

In brief

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

Key facts

Study ID

NCT02527798

Run by

University of North Carolina, Chapel Hill

People needed

82

Starts

2015-11-27

Expected to finish

2019-10-15

Last updated by the study team

2021-12-28

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital/University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• University of Florida Jacskonville Shands Medical Center — Jacksonville, Florida, United States
• Wolfson Children's Hospital — Jacksonville, Florida, United States
• South Miami Hospital — South Miami, Florida, United States
• John's Hopkins Al Children's Hospital — St. Petersburg, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Wesley Medical Center — Wichita, Kansas, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• University Medical Center of Southern Nevada — Las Vegas, Nevada, United States
• The University of North Carolina at Chapel Hill/North Carolina Children's Hospital — Chapel Hill, North Carolina, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital/The Ohio State University — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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