Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial
with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon
a difference in serum creatinine by one standard deviation. Fluid and salt intake will be
held constant within clinical parameters and carefully measured. Fenoldopam will be started
at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be
increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the
study. A study of pediatric patients previously provided to the FDA showed no hypotension at
a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of
indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will
include both blood and urine. The primary outcome will be a reduction in renal dysfunction,
as determined by creatinine and urine output over the course of treatment. Additional
outcomes will include determination of known and novel metabolomic urine markers of renal
dysfunction.