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

November 16, 2015 updated by: Hospital General Naval de Alta Especialidad - Escuela Medico Naval

The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
      • Distrito Federal, Mexico, 04477
        • Recruiting
        • Hospital General Naval de Alta Especialidad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgical treatment
Implement surgical treatment for closure of patent ductus arteriosus
Procedure: Surgical treatment
Standard left thoracotomy
Other Names:
  • 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 Names:
  • Pharmacological

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ) (%)
10 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month
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)
10 days after treatment
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)
1 month
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)
10 days
Death before discharge
Time Frame: 1 month
To compare related mortality among surgical and pharmacological treatment (%)
1 month
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).
1 month
Anatomy of the ductus arteriosus persistent
Time Frame: 1 month
Describe the size of the ductus arteriosus (mm)
1 month
Gestational age at birth
Time Frame: At birth
Describe the gestational age of neonates (weeks)
At birth
Apgar
Time Frame: At birth
Describe the Apgar score of newborns (3-9)
At birth
Blood flow
Time Frame: 1 month
Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)
1 month
Gradient of the ductus arteriosus
Time Frame: 1 month
Describe the gradient of the ductus arteriosus (mmHg).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

  • Principal Investigator: Esaú Luis Nieto, Pediatrician, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGNAE-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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