Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD)
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchopulmonary Dysplasia
Intervention: Furosemide Cohort 1 (Drug); Furosemide Cohort 2 (Drug); Furosemide Cohort 3 (Drug); Placebo (Other)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): Matthew M Laughon, MD, MPH, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill
Overall contact: Matthew M. Laughon, MD, MPH, Phone: 919-966-5063, Email: matt_laughon@med.unc.edu
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.
Clinical Details
Official title: Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary outcome: Safety as determined by adverse event experienced by participants. Description of safety of furosemide in premature infants at risk of BPD
Secondary outcome: Change in moderate-severe BPD or death risk from baselineClearance Volume of distribution Half life Area under the plasma concentration versus time curve (AUC) of furosemide Maximum concentration Peak Plasma Concentration (Cmax) of furosemide
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
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
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
Locations and Contacts
Matthew M. Laughon, MD, MPH, Phone: 919-966-5063, Email: matt_laughon@med.unc.edu
Coastal Carolina Pediatrics, Wilmington, North Carolina 28493, United States; Not yet recruiting Fernando Moya, MD Fernando Moya, MD, Principal Investigator
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States; Not yet recruiting Andrea Trembath, MD Andrea Trembath, MD, Principal Investigator
Additional Information
Starting date: August 2015
Last updated: August 17, 2015
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