Document Detail

Comparing sulindac with indomethacin for closure of ductus arteriosus in preterm infants.
MedLine Citation:
PMID:  9323621     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: A prospective study comparing the efficacy and side-effects of oral sulindac with intravenous indomethacin in clinically stable preterm infants (< 1750 g) requiring non-invasive closure of haemodynamically significant patent ductus arteriosus. METHODOLOGY: As maturity and birthweight are the two major determinants of ductal closure, infants were matched as closely as possible for these parameters. An eligible 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. RESULTS: The ductus arteriosus was successfully closed in all eight infants receiving indomethacin, and in seven of eight infants receiving sulindac. No significant differences were found with regards to the ductal size between the two groups at diagnosis or on each of the consecutive days of treatment (P > 0.25). More renal adverse effects were encountered in the indomethacin group. Significant differences in changes from baseline value for urine output, plasma sodium, urea and creatinine concentrations were noted at 24, 48 and 72 h after commencement of treatment between the two groups (P < 0.05). All the parameters returned to normal or pre-treatment levels 48 h after stopping therapy. Unexpectedly, severe gastrointestinal complications were encountered in the sulindac group. CONCLUSIONS: Sulindac is capable of promoting ductal constriction in clinically stable preterm infants without compromising the renal function. The spectrum of gastrointestinal complications observed in sulindac treated infants were similar to those described for indomethacin. The use of sulindac for ductal closure in the preterm infant should remain experimental.
P C Ng; K W So; T F Fok; M C Yam; M Y Wong; W Wong
Publication Detail:
Type:  Clinical Trial; Comparative Study; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  Journal of paediatrics and child health     Volume:  33     ISSN:  1034-4810     ISO Abbreviation:  J Paediatr Child Health     Publication Date:  1997 Aug 
Date Detail:
Created Date:  1998-01-09     Completed Date:  1998-01-09     Revised Date:  2007-09-24    
Medline Journal Info:
Nlm Unique ID:  9005421     Medline TA:  J Paediatr Child Health     Country:  AUSTRALIA    
Other Details:
Languages:  eng     Pagination:  324-8     Citation Subset:  IM    
Department of Paediatrics, Chinese University of Hong Kong, Hong Kong.
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MeSH Terms
Administration, Oral
Cyclooxygenase Inhibitors / administration & dosage*,  adverse effects
Drug Administration Schedule
Ductus Arteriosus, Patent / drug therapy*,  ultrasonography
Follow-Up Studies
Indomethacin / administration & dosage*,  adverse effects
Infant, Newborn
Infant, Premature*
Infusions, Intravenous
Kidney Function Tests
Liver Function Tests
Prospective Studies
Sulindac / administration & dosage*,  adverse effects
Treatment Outcome
Reg. No./Substance:
0/Cyclooxygenase Inhibitors; 38194-50-2/Sulindac; 53-86-1/Indomethacin

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