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Indomethacin treatment for symptomatic patent ductus arteriosus: a double-blind control study
Insights
Indomethacin effectively closes symptomatic patent ductus arteriosus in infants when given enterally every eight hours. This treatment is a safe alternative to surgery, with minimal side effects observed.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
- Pharmacology
Background:
- Symptomatic patent ductus arteriosus (PDA) is a common complication in preterm infants with severe respiratory distress syndrome.
- Medical management is often the first line of treatment, but surgical closure carries risks.
Purpose of the Study:
- To evaluate the efficacy and safety of enteral indomethacin for treating symptomatic PDA in infants.
- To compare different dosing intervals for indomethacin treatment.
Main Methods:
- A double-blind, placebo-controlled study involving 39 infants with symptomatic PDA.
- Infants received either enteral indomethacin (0.2 mg/kg) or placebo.
- Two dosing regimens were used: every 24 hours (Phase 1) and every 8 hours (Phase 2).
Main Results:
- Phase 1 showed no statistically significant difference in PDA closure rates between indomethacin and placebo groups due to high spontaneous closure in controls.
- Phase 2 demonstrated a significantly higher PDA closure rate (85%) in the indomethacin group compared to the control group (11%, P < .01).
- Phase 2 indomethacin use was associated with transient renal function impairment and mild gastrointestinal bleeding in a small percentage of infants.
Conclusions:
- Enteral administration of three 0.2 mg/kg indomethacin doses at eight-hour intervals is an effective treatment for symptomatic PDA.
- This regimen appears to be a safe alternative to surgical PDA closure in this patient population.
Abstract:
A double-blind control study was designed to determine the efficacy and safety of indomethacin treatment of patients with symptomatic patent ductus arteriosus. Infants with severe respiratory distress syndrome and symptomatic patent ductus arteriosus were eligible for the prospective study if the ratio of left atrial/aortic root diameter remained greater than or equal to 1.3:1 following a 24-hour period of medical management. Thirty-nine eligible infants were randomly assigned to the control or indomethacin group and given 0.2 mg/kg of enteral indomethacin or placebo in a double-blind manner. Second and third doses were administered at 24-hour intervals in phase 1 (17 patients), and at eight-hour intervals in phase 2 (22 patients). The 75% patent ductus arteriosus closure rate with indomethacin treatment in phase 1 was not statistically significant due to a 44% spontaneous closure rate in the control group. In phase 2, however, 85% of the indomethacin group demonstrated patent ductus arteriosus closure vs only 11% in the matched control group (P less than .01). Although no indomethacin side effects occurred in phase 1, in phase 2 indomethacin administration was associated with minimal, but statistically significant, transient impaired renal function and, in three infants (23%), mild upper gastrointestinal bleeding. In summary, enteral administration of three 0.2 mg/kg indomethacin doses at eight-hour intervals thus appears to be a safe and effective alternative to surgical closure.