Elsevier

The Journal of Pediatrics

Volume 155, Issue 6, December 2009, Pages 819-822.e1
The Journal of Pediatrics

Original Article
Duration of Indomethacin Treatment of the Preterm Patent Ductus Arteriosus as Directed by Echocardiography

https://doi.org/10.1016/j.jpeds.2009.06.013Get rights and content

Objective

To determine whether the duration of indomethacin administration could be shortened in infants with good early constrictive response of patent ductus arteriosus (PDA).

Study design

Infants born at < 30 weeks' gestational age were assessed with echocardiography in the first 12 hours of life and treated with indomethacin (0.1 mg/kg) if the PDA was > 2 mm in diameter. Randomization occurred before the second dose to either standard treatment (2 more doses of indomethacin at 0.1 mg/kg irrespective of echocardiographic findings) or to echocardiographically directed duration of indomethacin treatment (ECHO; further doses only if the PDA was >1.6 mm). Serial echocardiography was performed to day 28 of age. The primary outcome was failure of PDA closure.

Results

The infants were randomized to either the ECHO arm (n = 34) or the standard treatment arm (n = 40). No differences between the arms were seen in terms of failure of PDA closure, PDA reopening, need for further doses of indomethacin, or need for surgical ligation. More doses of indomethacin were given in the standard treatment arm (median, 3 doses [range, 1 to 12] vs 1 dose [range, 1 to 15]; P < .0001).

Conclusion

Echocardiographically directed duration of indomethacin treatment is effective in achieving PDA closure and offers the potential for dose minimization.

Section snippets

Methods

This study was conducted at a tertiary referral neonatal intensive care unit at Royal Prince Alfred Hospital, Sydney, Australia between 2003 and 2007. The study design was approved by the Human Research Ethics Committee of the Sydney South Area Health Service. Written informed parental consent was obtained before study commencement. Infants born before 30 weeks of gestational age (GA) and requiring respiratory support were eligible. In each infant, an echocardiogram was performed between 3 and

Results

We recruited 74 infants into the study between January 1, 2003 and June 30, 2007 (Figure 1; available at www.jpeds.com). Of 318 infants born before 30 weeks GA admitted to the nursery during this time period, 148 were eligible for the study, 138 either did not have a significant duct (< 2 mm) or had a closed duct, 72 were not approached, and 2 refused consent. During 2005, the study was suspended because there was no primary researcher on site. One infant was randomized to the standard treatment

Discussion

This study has shown that by tailoring the duration of indomethacin treatment to the ductal constrictive response 24hours after the first dose, it is possible to significantly reduce the exposure to the drug without affecting eventual successful closure rates. Empirically, this strategy for dose minimization would allow therapy for ductal closure to at a reduced risk of side effects. Our data are consistent with those reported by Su et al,6 who used the Doppler pattern of flow through the

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The authors declare no conflicts of interest.

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