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PEDIATRICS Vol. 112 No. 2 August 2003, pp. 345-350

Randomized Trial of Prolonged Low-Dose Versus Conventional-Dose Indomethacin for Treating Patent Ductus Arteriosus in Very Low Birth Weight Infants

Jiun Lee, MMed*, Victor Samuel Rajadurai, MRCP*, Keng Wee Tan, MMed*, Keng Yean Wong, MMed{ddagger}, Ee Hwee Wong, MSc§ and Joy Yoke Ngan Leong, MN§

* Departments of Neonatology
{ddagger} Pediatrics, KK Women’s and Children’s Hospital, Singapore, Singapore
§ Clinical Trials and Epidemiology Research Unit, Singapore, Singapore

Objective. Indomethacin is used for closing the patent ductus arteriosus in premature infants. Prolonged low-dose indomethacin given over 6 days could potentially improve closure rates because ductal constriction is maintained long enough for more effective anatomic closure. We compared the efficacy of this regimen to conventional dosing in a cohort of very low birth weight infants.

Methods. In a 2-arm clinical trial, 140 infants were randomized to either conventional dose (0.2 mg/kg/dose every 12 hours for 3 doses) or prolonged low-dose indomethacin (0.1 mg/kg/dose daily for 6 doses). The primary outcome measure was ductal closure rate, and the secondary outcomes were the need for a second course of treatment, surgical ligation rates, and side effects.

Results. Ductal closure after 1 course of indomethacin was similar between the 2 groups: 68% for the conventional dose group and 72% for the prolonged low dose (mean difference –4%; 95% confidence interval: –19% to 11%). The incidence of transient oliguria was higher in the conventional dose group, 31% versus 9%. There was a trend toward more necrotizing enterocolitis in the prolonged low-dose group, 7.0% versus 1.4%.

Conclusions. There was no difference in efficacy between the 2 dosing regimens. In view of this and with its higher incidence of necrotizing enterocolitis, we do not recommend using prolonged low-dose indomethacin for closing the patent ductus arteriosus in very low birth weight infants.

Key Words: patent ductus arteriosus • prolonged • indomethacin • premature infants • very low birth weight • randomized trial

Abbreviations: PDA, patent ductus arteriosus • VLBW, very low birth weight • NEC, necrotizing enterocolitis

Received for publication Jan 13, 2003; Accepted Feb 27, 2003.


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M. Sperandio, B. Beedgen, R. Feneberg, C. Huppertz, J. Brussau, J. Poschl, and O. Linderkamp
Effectiveness and Side Effects of an Escalating, Stepwise Approach to Indomethacin Treatment for Symptomatic Patent Ductus Arteriosus in Premature Infants Below 33 Weeks of Gestation
Pediatrics, December 1, 2005; 116(6): 1361 - 1366.
[Abstract] [Full Text] [PDF]

eLetters:

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Two dosing regimens for Indomethacin (RCT) , What is the evidence for change in practice?
Samir Gupta, et al.
Pediatrics Online, 11 Sep 2003 [Full text]
Actually we recommend no change in practice
Jiun Lee, et al.
Pediatrics Online, 29 Oct 2003 [Full text]