Overview

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

Status:
Active, not recruiting
Trial end date:
2021-12-15
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
The EMMES Corporation
Treatments:
Furosemide
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