The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants

NCT02602054 | Unknown Phase 2

• 1 other identifier: HGNAE-07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Ductus Arteriosus

Keywords

persistent ductus arteriosus; preterm infants; surgical treatment; pharmacological treatment

Outcome Measures

Primary Outcomes (1)

• Success rate of closure patent ductus arteriosus

  Tracking each patient for 10 days after treatment (surgical / pharmacological) to verify success rate of closure of patent ductus arteriosus (Failure of ductal closure ) (%)

  10 days after treatment

Secondary Outcomes (11)

• Time from diagnosis to resolution of patent ductus arteriosus

  1 month

• Time from start of treatment until resolution

  10 days after treatment

• Time limitation of family contact

  1 month

• Adverse effects and complications of treatment

  10 days

• Death before discharge

  1 month

Study Arms (2)

Surgical treatment

EXPERIMENTAL

Implement surgical treatment for closure of patent ductus arteriosus

Procedure: Surgical treatment

Control group

ACTIVE COMPARATOR

\- Indomethacin: Administer 1 full cycle (3 doses) of indomethacin (1 dose every 12 hours) for 2 days Dose 0.1 - 0.25 mg / kg \- Ibuprofen: Administer 1 full cycle (3 doses) of ibuprofen (1 dose every 24 hours) for 2 days Dose 05 - 10 mg / kg \- Acetaminophen: Administer 1 full cycle (12 doses) of acetaminophen (1 dose every 6 hours) for 3 days Dose 15 mg / kg

Drug: Control group

Interventions

Surgical treatment PROCEDURE

Standard left thoracotomy

Also known as: Surgery

Surgical treatment

Control group DRUG

\- Indomethacin: Administer 1 full cycle (3 doses) / (1 dose every 12 hours) in the first fourteen days of life: Preterm infants less than 48 hours of life: first dose 0.2 mg/kg, second dose 0.1 mg/kg and third dose 0.1 mg/kg Preterm infants more than 48 hours of life: first dose 0.2 mg/kg, second dose 0.2 mg/kg and third dose 0.2 mg/kg And preterm infants more than 7 days of life: first dose 0.2 mg/kg, second dose 0.25 mg/kg and third dose 0.25 mg/kg - Ibuprofen: Administer 1 full cycle (3 doses) / (1 dose every 24 hours) in the first fourteen days of life of preterm infants: First dose 10 mg/kg Second dose 05 mg/kg Third dose 05 mg/kg \- Acetaminophen Administer 1 full cycle, in the first fourteen days of life in preterm infants: Acetaminophen 15 mg/kg every 6 hours for 3 days

Also known as: Pharmacological

Control group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants
• Preterm infants hospitalized in the Neonatal Intensive Care Unit with a diagnosis of patent ductus arteriosus

You may not qualify if:

• Preterm infants with supportive treatment and / or drug prior to patent ductus arteriosus in another medical unit
• Preterm infants diagnosed with heart disease associated complex.
• Preterm infants with associated disease (not hemodynamic or cardiovascular) and its impact on his state of health prior to drug treatment and / or surgery
• Preterm infants with contraindications to pharmacological and / or surgery treatment
• Newborns diagnosed with patent ductus arteriosus but with incomplete medical records

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Study Sites (1)

Hospital General Naval de Alta Especialidad

Distrito Federal, Mexico City, 04477, Mexico

RECRUITING

Related Publications (18)

• 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

  RESULT

• Staines OH, Fuentes TMA, Staines AR. Tratamiento quirúrgico del conducto arterioso persistente. Rev Mex Cir Ped 2005; 12: 39-45.

  RESULT

• 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.

  PMID: 19128748 RESULT

• 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.

  RESULT

• Hernando BG, et al. Atención médica a niños < 30 semanas de gestación con conducto arterioso persistente. Rev Mex Pediatr. 2013; 80 (4): 131-135.

  RESULT

• 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.

  PMID: 23234752 RESULT

• 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.

  PMID: 25346899 RESULT

• 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.

  PMID: 23543702 RESULT

• 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.

  PMID: 24753708 RESULT

• 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.

  PMID: 25835756 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 25046256 RESULT

• 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.

  PMID: 24815768 RESULT

• 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.

  PMID: 16219273 RESULT

• 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.

  PMID: 17307530 RESULT

• 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.

  PMID: 15701582 RESULT

• 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.

  PMID: 18254095 RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Surgical Procedures, Operative; Control Groups

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Esaú Luis Nieto, Pediatrician

  Hospital General Naval de Alta Especialidad - Escuela Medico Naval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esaú Luis Nieto, Pediatrician

CONTACT

5564787736; dresauln@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2015
• First Posted: November 11, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: October 1, 2017
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

ME (1)