Extracorporeal Membrane Oxygenation (ECMO)

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: Completed
• Conditions: Extracorporeal Membrane Oxygenation
• Intervention / Treatment: Device: ECMO; Device: conventional mechanical ventilation

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: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	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 Outcome Measures

Outcome Measure	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	36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia	bronchopulmonary dysplasia was diagnosed after extubation	36 weeks' gestational age or before discharge from hospital

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: 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

Study Major Dates

• Study Start (Actual): November 11, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID 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