Extracorporeal Membrane Oxygenation (ECMO)

April 8, 2019 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Extracorporeal Membrane Oxygenation (ECMO) and Neonatal Outcomes:a Retrospective Multicenters Study

Since the 1970s, extracorporeal membrane oxygenation (ECMO) support has been used to support gas exchange for children with severe acute respiratory failure who fail mechanical ventilation. ECMO is more expensive than each of these other procedures.But its action is unclear

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Since 1974, eight randomized controlled trials have been reported in ECMO for respiratory failure, and none have included non-neonatal pediatric patients. Cochrane systematic reviews of this evidence concluded that ECMO for neonatal respiratory failure had a survival advantage, but there was insufficient evidence to demonstrate a survival advantage for ECMO used to support respiratory failure in adults. Moreover, these trials were performed prior to 2009, and since then advances in ECMO technology have enhanced the delivery of ECMO support, and new research has changed conventional management of severe acute respiratory distress syndrome (ARDS)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 hour to 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients will be eligible only when they reach the cutting line in the following:

Gestational age > 36 weeks, birth weight > 2 kg, day post-birth < 28 days.

Description

Inclusion Criteria:

1. ECMO group:

  1. Oxygenation Index > 40 for >4 hours
  2. Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation
  3. Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention
  4. Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure > 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.

2. Non-ECMO group:

  1. Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
  2. Vasoactive-inotropic score (VIS) ≥ 40 [VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100]

Exclusion Criteria:

  1. Gestational age < 36 weeks, birth weight < 2 kg, day post-birth > 28 days.
  2. lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
  3. irreversible brain damage
  4. uncontrolled bleeding
  5. Grade III or greater intraventricular hemorrhage
  6. ventilator days ≥ 15 days.

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ECMO
severe respiratory failure with ECMO
Device: ECMO
the patients with severe respiratory failure were supported by ECMO
conventional mechanical ventilation
severe respiratory failure with conventional mechanical ventilation
Device: conventional mechanical ventilation
the patients with severe respiratory failure were supported by conventional mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: 36 weeks' gestational age or before discharge from hospital
the patients died
36 weeks' gestational age or before discharge from hospital
28 days' mortality
Time Frame: 28 days
the patients died
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neonatal necrotizing enterocolitis
Time Frame: 36 weeks' gestational age or before discharge from hospital
Neonatal necrotizing enterocolitis was diagnosed after extubation
36 weeks' gestational age or before discharge from hospital
Intraventricular hemorrhage
Time Frame: 36 weeks' gestational age or before discharge from hospital
Intraventricular hemorrhage was diagnosed after extubation
36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia
Time Frame: 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia was diagnosed after extubation
36 weeks' gestational age or before discharge from hospital

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing 302 Hospital
The First Hospital of Jilin University
Hunan Provincial People's Hospital
Navy General Hospital, Beijing
Guangzhou Women and Children's Medical Center
Zhengzhou Children's Hospital, China
Children's Hospital of Chongqing Medical University
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECMO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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