Clinical trial NCT02527798: Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Official title: Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchopulmonary Dysplasia
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The Emmes Company, LLC
First posted: 2015-08-19
Enrollment: 82
Sex: ALL
Minimum age (years): 7
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety as Determined by Adverse Events
timeFrame: 35 days for each participant
Secondary outcomes:
measure: Moderate-Severe BPD or Death Risk Throughout Weekly Treatment
timeFrame: Risk measured weekly through Week 4
measure: Number of Participants With Moderate-Severe BPD or Death Risk as Clinically Determined
timeFrame: 36 weeks postmenstrual age
measure: Clearance
timeFrame: 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.
measure: Volume of Distribution
timeFrame: 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.
measure: Half-life
timeFrame: 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.
measure: Area Under the Plasma Concentration Versus Time Curve
timeFrame: 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.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital/University of Arkansas for Medical Sciences
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Jacksonville
country: United States
facility: University of Florida Jacskonville Shands Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: John's Hopkins Al Children's Hospital
state: Florida
city: South Miami
country: United States
facility: South Miami Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Boston
country: United States
facility: Floating Hospital for Children at Tufts Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill/North Carolina Children's Hospital
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital/The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Matthew Laughon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Jason E Lang, MD, MPH
role: STUDY_CHAIR
References: