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

Primary Purpose

Persistent Ductus Arteriosus

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Surgical treatment
Control group
Sponsored by
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Ductus Arteriosus focused on measuring persistent ductus arteriosus, preterm infants, surgical treatment, pharmacological treatment

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General Naval de Alta EspecialidadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgical treatment

Control group

Arm Description

Implement surgical treatment for closure of patent ductus arteriosus

- 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

Outcomes

Primary Outcome Measures

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 ) (%)

Secondary Outcome Measures

Time from diagnosis to resolution of patent ductus arteriosus
To compare the time from diagnosis to resolution of patent ductus arteriosus (days)
Time from start of treatment until resolution
To compare the time from start of treatment until resolution of patent ductus arteriosus (days)
Time limitation of family contact
To compare the time limitation of family contact from diagnosis to hospital discharge of newborns of patent ductus arteriosus (days)
Adverse effects and complications of treatment
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)
Death before discharge
To compare related mortality among surgical and pharmacological treatment (%)
Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2
To compare the duration of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 (days).
Anatomy of the ductus arteriosus persistent
Describe the size of the ductus arteriosus (mm)
Gestational age at birth
Describe the gestational age of neonates (weeks)
Apgar
Describe the Apgar score of newborns (3-9)
Blood flow
Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)
Gradient of the ductus arteriosus
Describe the gradient of the ductus arteriosus (mmHg).

Full Information

First Posted
November 8, 2015
Last Updated
November 16, 2015
Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
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1. Study Identification

Unique Protocol Identification Number
NCT02602054
Brief Title
The Best Treatment Strategy: Surgical vs Pharmacological to Close the Ductus Arteriosus Persistent in Preterm Infants
Official Title
The Best Treatment Strategy: Surgical Versus Pharmacological, to Close the Ductus Arteriosus Persistent in Preterm Infants. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Ductus Arteriosus
Keywords
persistent ductus arteriosus, preterm infants, surgical treatment, pharmacological treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical treatment
Arm Type
Experimental
Arm Description
Implement surgical treatment for closure of patent ductus arteriosus
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
- 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
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment
Other Intervention Name(s)
Surgery
Intervention Description
Standard left thoracotomy
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
Pharmacological
Intervention Description
- 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
Primary Outcome Measure Information:
Title
Success rate of closure patent ductus arteriosus
Description
Tracking each patient for 10 days after treatment (surgical / pharmacological) to verify success rate of closure of patent ductus arteriosus (Failure of ductal closure ) (%)
Time Frame
10 days after treatment
Secondary Outcome Measure Information:
Title
Time from diagnosis to resolution of patent ductus arteriosus
Description
To compare the time from diagnosis to resolution of patent ductus arteriosus (days)
Time Frame
1 month
Title
Time from start of treatment until resolution
Description
To compare the time from start of treatment until resolution of patent ductus arteriosus (days)
Time Frame
10 days after treatment
Title
Time limitation of family contact
Description
To compare the time limitation of family contact from diagnosis to hospital discharge of newborns of patent ductus arteriosus (days)
Time Frame
1 month
Title
Adverse effects and complications of treatment
Description
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)
Time Frame
10 days
Title
Death before discharge
Description
To compare related mortality among surgical and pharmacological treatment (%)
Time Frame
1 month
Title
Time of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2
Description
To compare the duration of mechanical ventilatory support, parenteral nutrition, fasting, supplementary O2 (days).
Time Frame
1 month
Title
Anatomy of the ductus arteriosus persistent
Description
Describe the size of the ductus arteriosus (mm)
Time Frame
1 month
Title
Gestational age at birth
Description
Describe the gestational age of neonates (weeks)
Time Frame
At birth
Title
Apgar
Description
Describe the Apgar score of newborns (3-9)
Time Frame
At birth
Title
Blood flow
Description
Describe the direction of blood flow of the ductus arteriosus (left-right, left-right, two-way)
Time Frame
1 month
Title
Gradient of the ductus arteriosus
Description
Describe the gradient of the ductus arteriosus (mmHg).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esaú Luis Nieto, Pediatrician
Phone
5564787736
Email
dresauln@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esaú Luis Nieto, Pediatrician
Organizational Affiliation
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Naval de Alta Especialidad
City
Distrito Federal
ZIP/Postal Code
04477
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esaú Luis Nieto, Pediatrician
Phone
5564787736
Email
dresauln@gmail.com

12. IPD Sharing Statement

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

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