Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320)

Melissa Liebowitz, Joseph Kaempf, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Ilene Sue WolfAmy Kimball, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Ronald I. Clyman

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks. Methods: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants). Results: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05–5.01)), followed by ibuprofen = 2.03 (1.05–3.91), and acetaminophen = 1.33 (0.55–3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)). Conclusion: Indomethacin was more effective than acetaminophen in producing ductus constriction.

Original languageEnglish (US)
Pages (from-to)599-607
Number of pages9
JournalJournal of Perinatology
Volume39
Issue number5
DOIs
StatePublished - May 1 2019

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

Cite this

Liebowitz, M., Kaempf, J., Erdeve, O., Bulbul, A., Håkansson, S., Lindqvist, J., Farooqi, A., Katheria, A., Sauberan, J., Singh, J., Nelson, K., Wickremasinghe, A., Dong, L., Hassinger, D. C., Aucott, S. W., Hayashi, M., Heuchan, A. M., Carey, W. A., Derrick, M., ... Clyman, R. I. (2019). Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320). Journal of Perinatology, 39(5), 599-607. https://doi.org/10.1038/s41372-019-0347-4