TY - JOUR
T1 - Comparative effectiveness of drugs used to constrict the patent ductus arteriosus
T2 - a secondary analysis of the PDA-TOLERATE trial (NCT01958320)
AU - Liebowitz, Melissa
AU - Kaempf, Joseph
AU - Erdeve, Omer
AU - Bulbul, Ali
AU - Håkansson, Stellan
AU - Lindqvist, Johanna
AU - Farooqi, Aijaz
AU - Katheria, Anup
AU - Sauberan, Jason
AU - Singh, Jaideep
AU - Nelson, Kelly
AU - Wickremasinghe, Andrea
AU - Dong, Lawrence
AU - Hassinger, Denise C.
AU - Aucott, Susan W.
AU - Hayashi, Madoka
AU - Heuchan, Anne Marie
AU - Carey, William A.
AU - Derrick, Matthew
AU - Wolf, Ilene Sue
AU - Kimball, Amy
AU - Sankar, Meera
AU - Leone, Tina
AU - Perez, Jorge
AU - Serize, Arturo
AU - Clyman, Ronald I.
N1 - Funding Information:
Acknowledgements We would like to thank the following PDA-TOLERATE investigators without whom this study would not have been possible: University of California San Francisco, San Francisco, CA: Scott Fields, PharmD; Providence St. Vincent Medical Center, Portland, OR: Lora Whitten, RN, Stefanie Rogers, MD; Ankara University School of Medicine Children’s Hospital, Ankara, Turkey: Emel Okulu, MD, Begum Atasay, MD, Saadet Arsan, MD; Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey: Ebru Türkoglu Ünal, MD; Sharp Mary Birch Hospital, San Diego, CA: Jane Steen, RN, Kathy Arnell, RN; University of Chicago, Chicago, IL: Sarah Holtschlag, RN, Michael Schreiber, MD; Morristown Medical Center, Morristown, NJ: Caryn Peters, RN; Johns Hopkins Hospital, Baltimore, MD: Maureen Gilmore, MD; University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, UK: Lorna McKay, RN, Dianne Carole, RN, Annette Shaw, RN; Mayo Clinic, Rochester, MN: Malinda Harris, MD, Amy Amsbaugh, RRT, Lavonne M. Liedl, RRT; Northshore University Health System, Evanston, IL: Avi Groner, MD; University of California San Diego and Rady Children’s Hospital, San Diego, CA: Erika Fernandez, MD, Jae Kim, MD, Renee Bridge, RN, Ellen Knodel, RN; Good Samaritan Hospital, San Jose, CA: Chrissy Weng, RN; South Miami Hospital/Baptist Health South Florida, Miami, FL: Magaly Diaz Barbosa, MD; Columbia University Medical Center, New York, NY: Richard Polin, MD, Marilyn Weindler, RN; Data Safety Monitoring Committee: Shahab Noori, MD, University of Southern California, Los Angeles, CA, Jeffrey Reese, MD, Vanderbilt University, Nashville, TN, Yao Sun, MD, University of California San Francisco, San Francisco, CA. We also would like to thank Dr. Mark Cocalis and the cardiologists at all of the participating institutions for their expert help in reading the echocardiograms. This work was supported by grants from the Gerber Foundation, U.S. Public Health Service National Heart, Lung and Blood Institute (HL109199), National Center for Advancing Translational Sciences, National Institutes of Health, through (UL1 TR001872, UL1 TR000004 and UL1TR001873), and a gift from the Jamie and Bobby Gates Foundation.
Publisher Copyright:
© 2019, Springer Nature America, Inc.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - 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.
AB - 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.
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U2 - 10.1038/s41372-019-0347-4
DO - 10.1038/s41372-019-0347-4
M3 - Article
C2 - 30850756
AN - SCOPUS:85062706736
SN - 0743-8346
VL - 39
SP - 599
EP - 607
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 5
ER -