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

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ClinicalTrials.gov Identifier: NCT02602054
Recruitment Status : Unknown
Verified November 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.

Condition or disease Intervention/treatment Phase
Persistent Ductus Arteriosus Procedure: Surgical treatment Drug: Control group Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgical treatment
Implement surgical treatment for closure of patent ductus arteriosus
Procedure: Surgical treatment
Standard left thoracotomy
Other Name: Surgery

Active Comparator: 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

Drug: 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

Other Name: Pharmacological




Primary Outcome Measures :
  1. Success rate of closure patent ductus arteriosus [ Time Frame: 10 days after treatment ]
    Tracking each patient for 10 days after treatment (surgical / pharmacological) to verify success rate of closure of patent ductus arteriosus (Failure of ductal closure ) (%)


Secondary Outcome Measures :
  1. Time from diagnosis to resolution of patent ductus arteriosus [ Time Frame: 1 month ]
    To compare the time from diagnosis to resolution of patent ductus arteriosus (days)

  2. Time from start of treatment until resolution [ Time Frame: 10 days after treatment ]
    To compare the time from start of treatment until resolution of patent ductus arteriosus (days)

  3. Time limitation of family contact [ Time Frame: 1 month ]
    To compare the time limitation of family contact from diagnosis to hospital discharge of newborns of patent ductus arteriosus (days)

  4. Adverse effects and complications of treatment [ Time Frame: 10 days ]
    Describe the type of adverse effects and / or complications (Chronic lung disease , Intraventricular haemorrhage, Creatinine level > 1.8 mg/dl, Pneumothorax , Sepsis, Necrotising enterocolitis, Retinopathy of prematurity, Other bleeding) and the frequency of the two study groups (yes / no)

  5. Death before discharge [ Time Frame: 1 month ]
    To compare related mortality among surgical and pharmacological treatment (%)

  6. Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 [ Time Frame: 1 month ]
    To compare the duration of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 (days).

  7. Anatomy of the ductus arteriosus persistent [ Time Frame: 1 month ]
    Describe the size of the ductus arteriosus (mm)

  8. Gestational age at birth [ Time Frame: At birth ]
    Describe the gestational age of neonates (weeks)

  9. Apgar [ Time Frame: At birth ]
    Describe the Apgar score of newborns (3-9)

  10. Blood flow [ Time Frame: 1 month ]
    Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)

  11. Gradient of the ductus arteriosus [ Time Frame: 1 month ]
    Describe the gradient of the ductus arteriosus (mmHg).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602054


Contacts
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Contact: Esaú Luis Nieto, Pediatrician 5564787736 dresauln@gmail.com

Locations
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Mexico
Hospital General Naval de Alta Especialidad Recruiting
Distrito Federal, Mexico, 04477
Contact: Esaú Luis Nieto, Pediatrician    5564787736    dresauln@gmail.com   
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
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Principal Investigator: Esaú Luis Nieto, Pediatrician Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Publications of 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
Staines OH, Fuentes TMA, Staines AR. Tratamiento quirúrgico del conducto arterioso persistente. Rev Mex Cir Ped 2005; 12: 39-45.
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.
Hernando BG, et al. Atención médica a niños < 30 semanas de gestación con conducto arterioso persistente. Rev Mex Pediatr. 2013; 80 (4): 131-135.
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.
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.

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Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02602054    
Other Study ID Numbers: HGNAE-07
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
persistent ductus arteriosus
preterm infants
surgical treatment
pharmacological treatment
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities