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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 baseline

Clearance

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

Page last updated: August 23, 2015

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