Overview

Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical College of Wisconsin
University of Iowa
Treatments:
Fenoldopam
Indomethacin
Criteria
Inclusion Criteria:

1. Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating

2. No previous exposure to indomethacin

3. Clinical determination to use indomethacin to attempt closure of PDA

4. No known congenital abnormalities involving the kidneys, heart or lungs

5. No preexisting renal dysfunction, defined as serum creatinine > 1.0 mg/dl, or urine
output <1.0 ml/kg/hour over the previous 24 hours.

Exclusion Criteria:

1. Enrollment in concurrent study in which interventions may contribute confounding
variables or have competing outcomes

2. Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities

3. Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment

4. Attending physician unwilling to have infant participate in study

5. Absence of informed consent