Clinical trial NCT03103022 - References

Patent Ductus Arteriosus — Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus

Citation(s)

•   Adamska E, Helwich E, Rutkowska M, Zacharska E, Piotrowska A
  [Comparison of the efficacy of ibuprofen and indomethacin in the treatment of patent ductus arteriosus in prematurely born infants]. Med Wieku Rozwoj. 2005 Jul-Sep;9(3 Pt 1):335-54. Polish.
•   Anderson BJ
  Paracetamol (Acetaminophen): mechanisms of action. Paediatr Anaesth. 2008 Oct;18(10):915-21. doi: 10.1111/j.1460-9592.2008.02764.x. Review.
•   Benitz WE
  Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis? J Perinatol. 2010 Apr;30(4):241-52. doi: 10.1038/jp.2010.3. Epub 2010 Feb 25. Review.
•   Benitz WE; Committee on Fetus and Newborn, American Academy of Pediatrics
  Patent Ductus Arteriosus in Preterm Infants. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3730. Epub 2015 Dec 15.
•   Coceani F, Baragatti B
  Mechanisms for ductus arteriosus closure. Semin Perinatol. 2012 Apr;36(2):92-7. doi: 10.1053/j.semperi.2011.09.018.
•   Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H
  Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS One. 2013 Nov 4;8(11):e77888. doi: 10.1371/journal.pone.0077888. eCollection 2013.
•   El-Mashad AE, El-Mahdy H, El Amrousy D, Elgendy M
  Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017 Feb;176(2):233-240. doi: 10.1007/s00431-016-2830-7. Epub 2016 Dec 21.
•   Erdeve O, Yurttutan S, Altug N, Ozdemir R, Gokmen T, Dilmen U, Oguz SS, Uras N
  Oral versus intravenous ibuprofen for patent ductus arteriosus closure: a randomised controlled trial in extremely low birthweight infants. Arch Dis Child Fetal Neonatal Ed. 2012 Jul;97(4):F279-83. doi: 10.1136/archdischild-2011-300532. Epub 2011 Dec 5.
•   Fenton TR, Kim JH
  A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59. Review.
•   Gokmen T, Erdeve O, Altug N, Oguz SS, Uras N, Dilmen U
  Efficacy and safety of oral versus intravenous ibuprofen in very low birth weight preterm infants with patent ductus arteriosus. J Pediatr. 2011 Apr;158(4):549-554.e1. doi: 10.1016/j.jpeds.2010.10.008. Epub 2010 Nov 20. Erratum in: J Pediatr. 2012 Jan;160(1):181.
•   Grèen K, Drvota V, Vesterqvist O
  Pronounced reduction of in vivo prostacyclin synthesis in humans by acetaminophen (paracetamol). Prostaglandins. 1989 Mar;37(3):311-5.
•   Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D
  Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011 Dec;128(6):e1618-21. doi: 10.1542/peds.2011-0359. Epub 2011 Nov 7.
•   Kessel I, Waisman D, Lavie-Nevo K, Golzman M, Lorber A, Rotschild A
  Paracetamol effectiveness, safety and blood level monitoring during patent ductus arteriosus closure: a case series. J Matern Fetal Neonatal Med. 2014 Nov;27(16):1719-21. doi: 10.3109/14767058.2013.871630. Epub 2014 Feb 7.
•   Koch J, Hensley G, Roy L, Brown S, Ramaciotti C, Rosenfeld CR
  Prevalence of spontaneous closure of the ductus arteriosus in neonates at a birth weight of 1000 grams or less. Pediatrics. 2006 Apr;117(4):1113-21.
•   Le J, Gales MA, Gales BJ
  Acetaminophen for patent ductus arteriosus. Ann Pharmacother. 2015 Feb;49(2):241-6. doi: 10.1177/1060028014557564. Epub 2014 Oct 28. Review.
•   Nemerofsky SL, Parravicini E, Bateman D, Kleinman C, Polin RA, Lorenz JM
  The ductus arteriosus rarely requires treatment in infants > 1000 grams. Am J Perinatol. 2008 Nov;25(10):661-6. doi: 10.1055/s-0028-1090594. Epub 2008 Oct 10.
•   Neumann R, Schulzke SM, Bührer C
  Oral ibuprofen versus intravenous ibuprofen or intravenous indomethacin for the treatment of patent ductus arteriosus in preterm infants: a systematic review and meta-analysis. Neonatology. 2012;102(1):9-15. doi: 10.1159/000335332. Epub 2012 Mar 8. Review.
•   Ohlsson A, Shah SS
  Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD004213. doi: 10.1002/14651858.CD004213.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 Jun 21;6:CD004213.
•   Olgun H, Ceviz N, Kartal I, Caner I, Karacan M, Tastekin A, Becit N
  Repeated Courses of Oral Ibuprofen in Premature Infants with Patent Ductus Arteriosus: Efficacy and Safety. Pediatr Neonatol. 2017 Feb;58(1):29-35. doi: 10.1016/j.pedneo.2015.04.017. Epub 2016 Apr 29.
•   Oncel MY, Erdeve O
  Oral medications regarding their safety and efficacy in the management of patent ductus arteriosus. World J Clin Pediatr. 2016 Feb 8;5(1):75-81. doi: 10.5409/wjcp.v5.i1.75. eCollection 2016 Feb 8. Review.
•   Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U
  Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.
•   Oncel MY, Yurttutan S, Uras N, Altug N, Ozdemir R, Ekmen S, Erdeve O, Dilmen U
  An alternative drug (paracetamol) in the management of patent ductus arteriosus in ibuprofen-resistant or contraindicated preterm infants. Arch Dis Child Fetal Neonatal Ed. 2013 Jan;98(1):F94. doi: 10.1136/archdischild-2012-302044. Epub 2012 May 18.
•   Papile LA, Burstein J, Burstein R, Koffler H
  Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529-34.
•   Peng S, Duggan A
  Gastrointestinal adverse effects of non-steroidal anti-inflammatory drugs. Expert Opin Drug Saf. 2005 Mar;4(2):157-69. Review.
•   Peterson RG
  Consequences associated with nonnarcotic analgesics in the fetus and newborn. Fed Proc. 1985 Apr;44(7):2309-13. Review.
•   Prescott S, Keim-Malpass J
  Patent Ductus Arteriosus in the Preterm Infant: Diagnostic and Treatment Options. Adv Neonatal Care. 2017 Feb;17(1):10-18. doi: 10.1097/ANC.0000000000000340. Review.
•   Ramos FG, Rosenfeld CR, Roy L, Koch J, Ramaciotti C
  Echocardiographic predictors of symptomatic patent ductus arteriosus in extremely-low-birth-weight preterm neonates. J Perinatol. 2010 Aug;30(8):535-9. doi: 10.1038/jp.2010.14. Epub 2010 Feb 25.
•   Romagnoli C, De Carolis MP, Papacci P, Polimeni V, Luciano R, Piersigilli F, Delogu AB, Tortorolo G
  Effects of prophylactic ibuprofen on cerebral and renal hemodynamics in very preterm neonates. Clin Pharmacol Ther. 2000 Jun;67(6):676-83.
•   Tekgunduz KS, Ceviz N, Demirelli Y, Olgun H, Caner I, Sahin IO, Yolcu C
  Intravenous paracetamol for patent ductus arteriosus in premature infants - a lower dose is also effective. Concerning the article by M.Y. Oncel et al: Intravenous paracetamol treatment in the management of patent ductus arteriosus in extremely low birth weight infants [Neonatology 2013;103:166-169]. Neonatology. 2013;104(1):6-7. doi: 10.1159/000348568. Epub 2013 Mar 26.
•   Terrin G, Conte F, Scipione A, Bacchio E, Conti MG, Ferro R, Ventriglia F, De Curtis M
  Efficacy of paracetamol for the treatment of patent ductus arteriosus in preterm neonates. Ital J Pediatr. 2014 Feb 20;40(1):21. doi: 10.1186/1824-7288-40-21.
•   Walsh MC, Kliegman RM
  Necrotizing enterocolitis: treatment based on staging criteria. Pediatr Clin North Am. 1986 Feb;33(1):179-201. Review.
•   Yurttutan S, Oncel MY, Arayici S, Uras N, Altug N, Erdeve O, Dilmen U
  A different first-choice drug in the medical management of patent ductus arteriosus: oral paracetamol. J Matern Fetal Neonatal Med. 2013 May;26(8):825-7. doi: 10.3109/14767058.2012.755162. Epub 2013 Jan 15.

Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus in Premature Infants: A Pilot Study

Details for clinical trial NCT03103022