Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants (Fenaki)
Patent Ductus Arteriosus (PDA), Acute Kidney Injury (AKI)
About this trial
This is an interventional prevention trial for Patent Ductus Arteriosus (PDA)
Eligibility Criteria
Inclusion Criteria:
- Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating
- No previous exposure to indomethacin
- Clinical determination to use indomethacin to attempt closure of PDA
- No known congenital abnormalities involving the kidneys, heart or lungs
- 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:
- Enrollment in concurrent study in which interventions may contribute confounding variables or have competing outcomes
- Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities
- Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment
- Attending physician unwilling to have infant participate in study
- Absence of informed consent
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control
Fenoldopam
Infants in the Placebo arm will receive 0.9% sodium chloride (0.1 ml/hr). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion (in this arm the placebo) will be increased to 0.2 ml/kg/hr. This rate will be continued throughout the remainder of the study.
Infants in the experimental arm will receive fenoldopam (60 ug/ml; 0.1 ml/hr to provide 0.1ug/kg/min). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 ml/kg/hr (0.2 ug/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study.