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



Status:Active, not recruiting
Conditions:Bronchitis
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:10/10/2018
Start Date:August 2015
End Date:June 2020

Use our guide to learn which trials are right for you!

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

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

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.

Inclusion Criteria:

1. 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)

2. < 29 weeks gestational age at birth

3. 7-28 days postnatal age at time of first study dose

Exclusion Criteria:

1. Exposure to any diuretic ≤ 72 hours prior to first study dose

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
We found this trial at
21
sites
Jacksonville, Florida 32207
Principal Investigator: Mark Hudak, MD
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: Alaa-Eldin Eldemerdash, MD
Phone: 702-207-8345
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
740 South Limestone Street
Lexington, Kentucky 40536
Principal Investigator: Mina Hanna, MD
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Principal Investigator: Varsha Mehta, MD
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Boston, Massachusetts 02111
Principal Investigator: Anijali Lyengar, MD
?
mi
from
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Principal Investigator: Sofia R. Aliaga, MD, MHP
Phone: 984-974-7846
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Prem Shekhawat, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Children's Drive
Columbus, Ohio 43205
Principal Investigator: Jonathan Slaughter, MD
Phone: 614-355-6626
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Jacksonville, Florida 32209
Principal Investigator: Mark Hudak, MD
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64108
Principal Investigator: Tamorah Lewis, MD
Phone: 816-234-3920
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Little Rock, Arkansas 72202
Principal Investigator: Sherry Courtney, MD
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Aprille Febre, MD
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Autumn Kiefer, MD
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Kimberly Ernst, MD
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Joseph El Khoury, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
501 6th Avenue South
Saint Petersburg, Florida 33701
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
South Miami, Florida 33143
Principal Investigator: Jorge Perez, MD
?
mi
from
South Miami, FL
Click here to add this to my saved trials
550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Principal Investigator: Barry Bloom, MD
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wilmington, North Carolina 28401
Principal Investigator: Fernando Moya, MD
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01605
Principal Investigator: Lawrence Rhein, MD
Phone: 508-334-8315
?
mi
from
Worcester, MA
Click here to add this to my saved trials