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

NCT ID: NCT02602054

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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The ductus arteriosus varies in length, diameter and morphology. The duct closure occurs in two stages: the first one or functional closure; the second or anatomical closure. This condition is associated with other heart diseases, which modify the natural history and require individualized treatment. Treatment varies from conservative, pharmacological or surgical treatment, and there are many controversies regarding the treatment decision. And aims of the closure, is to decrease the likelihood of irreversible pulmonary vascular disease, reduce associated morbidity and mortality. The role of prostaglandin E2 is the permeability of the conduit, by which is indicated the use of cyclooxygenase inhibitors for closure (indomethacin and ibuprofen). In various research studies many factors associated with failure of pharmacological treatment (gestational age, antenatal indomethacin less than 48 hours before delivery, use of high frequency ventilation) are reported, therefore, there is an alternative treatment which is surgical closure. In the pharmacological treatment of ductus arteriosus persistent it should be individualized according to gestational age, respiratory condition and size of the newborn. With early drug treatment can achieve closure of patent ductus arteriosus in up to 90% of cases, while the late treatment between 50-65%. However, it is reported that after treatment with indomethacin, reopening occurs, two doses are recommended more after the first, in addition to its side effects, contraindications and complications. As well, ibuprofen contraindications. So the closure of the ductus arteriosus persistent may be performed by hemodynamics and surgical closure (standard left thoracotomy or thoracoscopic technique). There are specific indications for surgical treatment (no response to two cycles of medical treatment in newborns with less than 1000 gr weight in which I fail one indomethacin, absolute contraindications to it, with significant hemodynamic repercussions. With surgical treatment before the third week of life minimizing morbidity. it is reported by many authors that complications are rare and mortality is associated with other complications of prematurity. So Surgical treatment is considered as an alternative because of its low incidence of complications, mortality and lower cost, plus a total occlusion between 94-100% Because of this, the treatment of patent ductus arteriosus in preterm infants, ranging from conservative treatment, medical or surgical, and currently there is much controversy in the treatment decision.

This study aims to determine the efficacy and safety of surgical versus pharmacological treatment for the permanent closure of the patent ductus arteriosus in preterm infants.

Methods: Is open label randomized controlled the clinical trial with: 1) experimental group assigned to surgical treatment; 2) control group assigned to pharmacological treatment, for closure of patent ductus arteriosus.

Conditions

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Persistent Ductus Arteriosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment

Implement surgical treatment for closure of patent ductus arteriosus

Group Type EXPERIMENTAL

Surgical treatment

Intervention Type PROCEDURE

Standard left thoracotomy

Control group

\- 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

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type 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

Interventions

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Surgical treatment

Standard left thoracotomy

Intervention Type PROCEDURE

Control group

\- 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

Intervention Type DRUG

Other Intervention Names

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Surgery Pharmacological

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Naval de Alta Especialidad - Escuela Medico Naval

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esaú Luis Nieto, Pediatrician

Role: PRINCIPAL_INVESTIGATOR

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Locations

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Hospital General Naval de Alta Especialidad

Distrito Federal, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Esaú Luis Nieto, Pediatrician

Role: CONTACT

[email protected]
5564787736

Facility Contacts

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Esaú Luis Nieto, Pediatrician

Role: primary

[email protected]
5564787736

References

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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

Reference Type RESULT

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

Reference Type 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.

Reference Type RESULT
PMID: 19128748 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 23234752 (View on PubMed)

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.

Reference Type RESULT
PMID: 25346899 (View on PubMed)

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.

Reference Type RESULT
PMID: 23543702 (View on PubMed)

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.

Reference Type RESULT
PMID: 24753708 (View on PubMed)

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.

Reference Type RESULT
PMID: 25835756 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type RESULT
PMID: 25046256 (View on PubMed)

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.

Reference Type RESULT
PMID: 24815768 (View on PubMed)

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.

Reference Type RESULT
PMID: 16219273 (View on PubMed)

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.

Reference Type RESULT
PMID: 17307530 (View on PubMed)

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.

Reference Type RESULT
PMID: 15701582 (View on PubMed)

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.

Reference Type RESULT
PMID: 18254095 (View on PubMed)

Other Identifiers

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HGNAE-07

Identifier Type: -

Identifier Source: org_study_id