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

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

November 27, 2015

Primary Completion Date

October 15, 2019

Study Completion Date

October 15, 2019

Conditions
Bronchopulmonary Dysplasia
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

OTHER

Placebo

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

Trial Locations (21)

23298

Virginia Commonwealth University, Richmond

26506

West Virginia University, Morgantown

28403

New Hanover Regional Medical Center, Wilmington

32209

University of Florida Jacskonville Shands Medical Center, Jacksonville

Wolfson Children's Hospital, Jacksonville

33143

South Miami Hospital, South Miami

33701

John's Hopkins Al Children's Hospital, St. Petersburg

40536

University of Kentucky Medical Center, Lexington

43205

Nationwide Children's Hospital/The Ohio State University, Columbus

44109

MetroHealth Medical Center, Cleveland

60612

University of Illinois at Chicago, Chicago

64108

Children's Mercy Hospital and Clinics, Kansas City

67214

Wesley Medical Center, Wichita

72202

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

73104

University of Oklahoma Health Sciences Center, Oklahoma City

89102

University Medical Center of Southern Nevada, Las Vegas

92354

Loma Linda University Medical Center, Loma Linda

02111

Floating Hospital for Children at Tufts Medical Center, Boston

01605

UMass Memorial Medical Center, Worcester

48109-4225

University of Michigan Medical Center, Ann Arbor

27599-7596

The University of North Carolina at Chapel Hill/North Carolina Children's Hospital, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Duke University

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER