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

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