Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Apr-Jun;13(2):130-135.
doi: 10.4103/apc.APC_115_19. Epub 2020 Feb 14.

Comparison of the efficacy and safety of indomethacin, ibuprofen, and paracetamol in the closure of patent ductus arteriosus in preterm neonates - A randomized controlled trial

Vasudha Meena  1 , Durga Shankar Meena  2 , Pradeep Singh Rathore  1 , Sandeep Chaudhary  1 , Jai Prakash Soni  1
Affiliations

Comparison of the efficacy and safety of indomethacin, ibuprofen, and paracetamol in the closure of patent ductus arteriosus in preterm neonates - A randomized controlled trial

Vasudha Meena et al. Ann Pediatr Cardiol. 2020 Apr-Jun.

Abstract

Introduction: In this prospective study, we compared the efficacy and safety of ibuprofen, indomethacin, and paracetamol in the closure of patent ductus arteriosus (PDA) in preterm neonates.

Materials and methods: This randomized prospective study was conducted in the Division of Pediatric Cardiology, M. D. M and Umaid Hospital, Jodhpur. A total of 105 preterm neonates with gestational age <37 weeks and hemodynamically significant PDA (hs-PDA) diagnosed clinically and confirmed by echocardiography were enrolled. All neonates were randomly assigned in a ratio of 1:1:1 to oral indomethacin (Group A, 3 doses at an interval of 12 h with a starting dose of 0.2 mg/kg), oral ibuprofen (Group B, 10 mg/kg ibuprofen followed by 5 mg/kg/day for 2 days), or IV paracetamol (Group C, 15 mg/kg every 6 hourly for 3 consecutive days). After the completion of the first course, neonates were assessed clinically as well as by echocardiography to confirm PDA closure. If PDA remained open, the second course of the same drug was given and repeat assessment was done within 24 h of the last dose. In addition to an echocardiographic examination, complete blood counts, renal and liver function tests were performed.

Results: Our study shows that there was no significant difference observed in PDA closure among all the three treatment groups after the completion of two courses of treatment. The cumulative rate of PDA closure was 68% in the indomethacin group, 77.14% in the ibuprofen group, and 71.43% in the paracetamol group (P = 0.716). There were no significant changes found in Hb, platelet, blood urea nitrogen (BUN), creatinine, and liver enzymes after treatment in the paracetamol group (P > 0.05). BUN and serum creatinine levels were significantly increased after treatment in indomethacin and ibuprofen groups (P < 0.0001 and P < 0.05, respectively).

Conclusion: Our study shows that IV paracetamol is as effective as indomethacin and ibuprofen in promoting the closure of hs-PDA in premature infants with a better safety profile.

Keywords: Doppler; echocardiography; patent ductus arteriosus; rescue drugs.

PubMed Disclaimer

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
Patent ductus arteriosus closure in neonates according to the treatment group
See this image and copyright information in PMC

References

    1. Clyman RI. Ibuprofen and patent ductus arteriosus. N Engl J Med. 2000;343:728–30. - PubMed
    1. El Hajjar M, Vaksmann G, Rakza T, Kongolo G, Storme L. Severity of the ductal shunt: A comparison of different markers. Arch Dis Child Fetal Neonatal Ed. 2005;90:F419–22. - PMC - PubMed
    1. Jim WT, Chiu NC, Chen MR, Hung HY, Kao HA, Hsu CH, et al. Cerebral hemodynamic change and intraventricular hemorrhage in very low birth weight infants with patent ductus arteriosus. Ultrasound Med Biol. 2005;31:197–202. - PubMed
    1. Lee LC, Tillett A, Tulloh R, Yates R, Kelsall W. Outcome following patent ductus arteriosus ligation in premature infants: A retrospective cohort analysis. BMC Pediatr. 2006;6:15. - PMC - PubMed
    1. Schmidt B, Roberts RS, Fanaroff A, Davis P, Kirpalani HM, Nwaesei C, et al. Indomethacin prophylaxis, patent ductus arteriosus, and the risk of bronchopulmonary dysplasia: Further analyses from the Trial of Indomethacin Prophylaxis in Preterms (TIPP) J Pediatr. 2006;148:730–4. - PubMed