Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
4 other identifiers
interventional
82
1 country
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2015
Typical duration for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedStudy Start
First participant enrolled
November 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedResults Posted
Study results publicly available
December 28, 2021
CompletedDecember 28, 2021
September 1, 2021
3.9 years
August 4, 2015
August 20, 2021
November 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety as Determined by Adverse Events
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.
35 days for each participant
Secondary Outcomes (6)
Moderate-Severe BPD or Death Risk Throughout Weekly Treatment
Risk measured weekly through Week 4
Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined
36 weeks postmenstrual age
Clearance
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.
Volume of Distribution
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.
Half-life
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.
- +1 more secondary outcomes
Study Arms (6)
Furosemide Cohort 1
EXPERIMENTALWithin 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.
Placebo Cohort 1
PLACEBO COMPARATORInfants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Furosemide Cohort 2
EXPERIMENTALCohort 2 Infants will receive furosemide (1mg/kg every 6 hours intravenously or 2 mg/kg every 6 hours daily enterally) for 28 days.
Furosemide Cohort 3
EXPERIMENTALCohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.
Placebo Cohort 2
PLACEBO COMPARATORInfants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Placebo Cohort 3
PLACEBO COMPARATORInfants randomized to the placebo treatment group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
Interventions
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.
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.
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.
Sugar water will be administered in a equivalent volume as drug intervention.
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Arkansas Children's Hospital/University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
University of Florida Jacskonville Shands Medical Center
Jacksonville, Florida, 32209, United States
Wolfson Children's Hospital
Jacksonville, Florida, 32209, United States
South Miami Hospital
South Miami, Florida, 33143, United States
John's Hopkins Al Children's Hospital
St. Petersburg, Florida, 33701, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, 02111, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-4225, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
The University of North Carolina at Chapel Hill/North Carolina Children's Hospital
Chapel Hill, North Carolina, 27599-7596, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28403, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Nationwide Children's Hospital/The Ohio State University
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (1)
Greenberg RG, Lang J, Smith PB, Shekhawat P, Courtney SE, Hudak ML, Moya F, Iyengar A, Eldemerdash A, Bloom B, Go M, Hanna M, Rhein L, Aliaga S, Lewis T, Febre A, Kiefer AS, Bhatt-Mehta V, Khoury JA, Selewski D, Anand R, Martz K, Payne EH, Zimmerman KO, Benjamin DK Jr, Laughon M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Furosemide Safety in Preterm Infants at Risk for Bronchopulmonary Dysplasia: A Randomized Clinical Trial. J Pediatr. 2025 Aug;283:114629. doi: 10.1016/j.jpeds.2025.114629. Epub 2025 Apr 28.
PMID: 40306549DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Leigh Gosnell
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Laughon, MD, MPH
University of North Carolina, Chapel Hill
- STUDY CHAIR
Jason E Lang, MD, MPH
Duke University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 19, 2015
Study Start
November 27, 2015
Primary Completion
October 15, 2019
Study Completion
October 15, 2019
Last Updated
December 28, 2021
Results First Posted
December 28, 2021
Record last verified: 2021-09