drugset / Trial / NCT02602054
The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
RandomizedParallel-groupOpen-labelTreatment
Summary
The decision to treat patent ductus arteriosus in preterm infants, varies from a conservative, medical or immediate surgical treatment; although, at present, there is some controversy about this decision. This study aims to determine the efficacy and safety of surgical versus pharmacological treatment of patent ductus arteriosus in preterm infants.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-04
- Completion
- 2017-10
Publications
- Results Gallardo MAF, González SJM, et al. Experiencia en el cierre quirúrgico de ducto arterioso permeable en la Unidad de Cuidados Intensivos Neonatales de un hospital de segundo nivel en Guadalajara, Jalisco, México. Bol Med Hosp Infant Mex 2010; 67: 128-32
- Results Staines OH, Fuentes TMA, Staines AR. Tratamiento quirúrgico del conducto arterioso persistente. Rev Mex Cir Ped 2005; 12: 39-45.
- Results Golombek SG, Sola A, Baquero H, Borbonet D, Cabanas F, Fajardo C, Goldsmit G, Lemus L, Miura E, Pellicer A, Perez JM, Rogido M, Zambosco G, van Overmeire B; Primer Grupo de Consenso Clinico SIBEN. [First SIBEN clinical consensus: diagnostic and therapeutic approach to patent ductus arteriosus in premature newborns]. An Pediatr (Barc). 2008 Nov;69(5):454-81. doi: 10.1157/13128003. Spanish.
- Results Elorza MD, Pérez RJ, Quero JJ. Tratamiento del Ductus Arterioso Persistente sintomático del recién nacido pretérmino. Hospital Universitario La Paz. Servicio Madrileño de Salud. 2005 (3): 1-8.
- Results Hernando BG, et al. Atención médica a niños < 30 semanas de gestación con conducto arterioso persistente. Rev Mex Pediatr. 2013; 80 (4): 131-135.
- Results San Luis-Miranda R, Arias-Monroy LG, Peralta-Pedrero ML, Lazaro-Castillo JL, Leon-Avila JL, Benitez-Arechiga ZM, Jauregui-Ruiz O, Yanez-Gutierrez L, Manrique-Valle M. [Clinical guide practice. Patent ductus arteriosus]. Rev Med Inst Mex Seguro Soc. 2012 Jul-Aug;50(4):453-63. Spanish.
- Results Lee JH, Ro SK, Lee HJ, Park HK, Chung WS, Kim YH, Kang JH, Kim H. Surgical Ligation on Significant Patent Ductus Arteriosus in Very Low Birth Weight Infants: Comparison between Early and Late Ligations. Korean J Thorac Cardiovasc Surg. 2014 Oct;47(5):444-50. doi: 10.5090/kjtcs.2014.47.5.444. Epub 2014 Oct 5.
- Results Moore GP, Lawrence SL, Maharajh G, Sumner A, Gaboury I, Barrowman N, Lemyre B. Therapeutic strategies, including a high surgical ligation rate, for patent ductus arteriosus closure in extremely premature infants in a North American centre. Paediatr Child Health. 2012 Apr;17(4):e26-31. doi: 10.1093/pch/17.4.e26.
- Results Sung SI, Choi SY, Park JH, Lee MS, Yoo HS, Ahn SY, Chang YS, Park WS. The timing of surgical ligation for patent ductus arteriosus is associated with neonatal morbidity in extremely preterm infants born at 23-25 weeks of gestation. J Korean Med Sci. 2014 Apr;29(4):581-6. doi: 10.3346/jkms.2014.29.4.581. Epub 2014 Apr 1.
- Results Lam JY, Lopushinsky SR, Ma IWY, Dicke F, Brindle ME. Treatment Options for Pediatric Patent Ductus Arteriosus: Systematic Review and Meta-analysis. Chest. 2015 Sep;148(3):784-793. doi: 10.1378/chest.14-2997.
- Results Kim HK, et al. Effect of indomethacin treatment in full-term infants with symptomatic patent ductus arteriosus. Korean J Perinatol 2013; 24 (4): 237-43.
- Results Kwon NH, Lee JH, et al. Risk Factors of Failure of Ibuprofen Treatment in Preterm Infants with HS PDA. Korean J Perinatol 2014; 25 (4): 257-65.
- Results Sadeck LS, Leone CR, Procianoy RS, Guinsburg R, Marba ST, Martinez FE, Rugolo LM, Moreira ME, Fiori RM, Ferrari LL, Menezes JA, Venzon PS, Abdallah VQ, Duarte JL, Nunes MV, Anchieta LM, Alves Filho N. Effects of therapeutic approach on the neonatal evolution of very low birth weight infants with patent ductus arteriosus. J Pediatr (Rio J). 2014 Nov-Dec;90(6):616-23. doi: 10.1016/j.jped.2014.04.010. Epub 2014 Jul 19.
- Results Lopez Sousa M, Perez Feal A, Soto A, Fraga JM, Couce ML. [Left vocal cord paralysis after patent ductus arteriosus surgery]. An Pediatr (Barc). 2015 Jan;82(1):e7-e11. doi: 10.1016/j.anpedi.2014.04.001. Epub 2014 May 10. Spanish.
- Results Gimeno Navarro A, Cano Sanchez A, Fernandez Gilino C, Carrasco Moreno JI, Izquierdo Macian I, Gutierrez Laso A, Morcillo Sopena F. [Ibuprofen versus indomethacin in the treatment of patent ductus arteriosus in preterm infants]. An Pediatr (Barc). 2005 Sep;63(3):212-8. doi: 10.1157/13078483. Spanish.
- Results Clyman RI, Chorne N. Patent ductus arteriosus: evidence for and against treatment. J Pediatr. 2007 Mar;150(3):216-9. doi: 10.1016/j.jpeds.2006.12.048. No abstract available.
- Results Van Overmeire B, Chemtob S. The pharmacologic closure of the patent ductus arteriosus. Semin Fetal Neonatal Med. 2005 Apr;10(2):177-84. doi: 10.1016/j.siny.2004.10.003. Epub 2004 Dec 15.
- Results Mosalli R, Alfaleh K. Prophylactic surgical ligation of patent ductus arteriosus for prevention of mortality and morbidity in extremely low birth weight infants. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD006181. doi: 10.1002/14651858.CD006181.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 15 mg/kg | — |
| Comparator | Ibuprofen | Small molecule | 5 mg/kg | — |
| Comparator | Ibuprofen | Small molecule | 10 mg/kg | — |
| Comparator | Indomethacin | Small molecule | 0.1 mg/kg | — |
| Comparator | Indomethacin | Small molecule | 0.2 mg/kg | — |
| Comparator | Indomethacin | Small molecule | 0.25 mg/kg | — |