COMPARING SULINDAC WITH INDOMETHACIN FOR CLOSURE OF DUCTUS-ARTERIOSUSIN PRETERM INFANTS

Objectives: A prospective study comparing the efficiacy and side-effec ts of oral sulindac with intravenous indomethacin in clinically stable preterm infants (<1750 g) requiring non-invasive closure of haemodyna mically significant patent ductus arteriosus. Methodology: As maturity and birthweight are the two major determinants of ductal closure, inf ants were matched as closely as possible for these parameters. An elig ible patient was first assigned to the sulindac group and a subsequent patient with similar gestational age (+/-1 week) and birthweight (+/- 100 g) to the previously recruited infant would automatically receive indomethacin. A total of eight infants were enrolled in each group, R esults: The ductus arteriosus was successfully closed in all eight inf ants receiving indomethacin, and in seven of eight infants receiving s ulindac. No significant differences were found with regards to the duc tal size between the two groups at diagnosis or on each of the consecu tive days of treatment (P>0.25). More renal adverse effects were encou ntered in the indomethacin group. Significant differences in changes f rom baseline value for urine output, plasma sodium, urea and creatinin e concentrations were noted at 24, 48 and 72 h after commencement of t reatment between the two groups (P<0.05). All the parameters returned to normal or pre-treatment levels 48 h after stopping therapy. Unexpec tedly, severe gastrointestinal complications were encountered in the s ulindac group. Conclusions: Sulindac is capable of promoting ductal co nstriction in clinically stable preterm infants without compromising t he renal function. The spectrum of gastrointestinal complications obse rved in sulindac treated infants were similar to those described for i ndomethacin. The use of sulindac for ductal closure in the preterm inf ant should remain experimental.