Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
NCT ID: NCT02527798
Last Updated: 2021-12-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2015-11-27
2019-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Furosemide Cohort 1
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.
Furosemide Cohort 1
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.
Placebo Cohort 1
Infants 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
Sugar water will be administered in a equivalent volume as drug intervention.
Furosemide Cohort 2
Cohort 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 2
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 Cohort 3
Cohort 3 Infants will receive furosemide (2mg/kg every 6 hours intravenously or 4 mg/kg every 6 hours daily enterally) for 28 days.
Furosemide Cohort 3
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.
Placebo Cohort 2
Infants 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
Sugar water will be administered in a equivalent volume as drug intervention.
Placebo Cohort 3
Infants 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
Sugar water will be administered in a equivalent volume as drug intervention.
Interventions
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Furosemide Cohort 1
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 Cohort 2
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 Cohort 3
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.
Placebo
Sugar water will be administered in a equivalent volume as drug intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. \< 29 weeks gestational age at birth
3. 7-28 days postnatal age at time of first study dose
Exclusion Criteria
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
7 Days
28 Days
ALL
No
Sponsors
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Duke University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The Emmes Company, LLC
INDUSTRY
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Matthew Laughon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Jason E Lang, MD, MPH
Role: STUDY_CHAIR
Duke University
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HHSN27500033
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HHSN27500035
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
15-1978
Identifier Type: -
Identifier Source: org_study_id