Extracorporeal Membrane Oxygenation (ECMO)

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03607760
• Other study ID #: ECMO
• Status: Completed
• Start date: November 11, 2018
• Est. completion date: April 4, 2019

Study information

• Verified date: November 2018
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 4, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation

Intervention

Device:
• ECMO
the patients with severe respiratory failure were supported by ECMO
• conventional mechanical ventilation
the patients with severe respiratory failure were supported by conventional mechanical ventilation

Locations

Country	Name	City	State
China	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Chongqing	Chongqing

Sponsors (9)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Bayi Children's Hospital Affiliated to PLA Army General Hospital, China, Beijing 302 Hospital, Children's Hospital of Chongqing Medical University, First Hospital of Jilin University, Guangzhou Women and Children's Medical Center, Hunan Provincial People's Hospital, the general navy hospital of the PLA, Zhengzhou Children's Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality	the patients died	36 weeks' gestational age or before discharge from hospital
Primary	28 days' mortality	the patients died	28 days
Secondary	Neonatal necrotizing enterocolitis	Neonatal necrotizing enterocolitis was diagnosed after extubation	36 weeks' gestational age or before discharge from hospital
Secondary	Intraventricular hemorrhage	Intraventricular hemorrhage was diagnosed after extubation	36 weeks' gestational age or before discharge from hospital
Secondary	bronchopulmonary dysplasia	bronchopulmonary dysplasia was diagnosed after extubation	36 weeks' gestational age or before discharge from hospital