Extracorporeal Membrane Oxygenation (ECMO) | NCT03607760

Studies
Extracorporeal Membrane Oxygenation (ECMO)

NCT03607760

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Completed

Last Update Posted

Apr 10, 2019Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation

Interventions

ECMO
conventional mechanical ventilation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2018Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Apr 4, 2019Actual

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Jul 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2019

Last Update Posted Date

Apr 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Name	Class
Bayi Children's Hospital Affiliated to PLA Army General Hospital, China	OTHER
Children's Hospital of Chongqing Medical University	OTHER
Hunan Provincial People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECMO		severe respiratory failure with ECMO	Device: ECMO
conventional mechanical ventilation		severe respiratory failure with conventional mechanical ventilation	Device: conventional mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO	Device	the patients with severe respiratory failure were supported by ECMO	ECMO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
in-hospital mortality	the patients died	36 weeks' gestational age or before discharge from hospital
28 days' mortality	the patients died	28 days

Secondary Outcomes

Measure	Description	Time Frame
Neonatal necrotizing enterocolitis	Neonatal necrotizing enterocolitis was diagnosed after extubation	36 weeks' gestational age or before discharge from hospital
Intraventricular hemorrhage	Intraventricular hemorrhage was diagnosed after extubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. ECMO group:

Oxygenation Index > 40 for >4 hours
Failure to wean from 100% oxygen despite prolonged (> 48h) maximal medical therapy or persistent episodes of decompensation
Severe hypoxic respiratory failure with acute decompensation (PaO2 <40) unresponsive to intervention
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:

Oxygenation Index > 16 and reach the Montreux definition of severe respiratory distress syndrome
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:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Hour

Maximum Age

1 Month

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample