Extracorporeal Membrane Oxygenation (ECMO)

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Device: ECMO
* Device: conventional mechanical ventilation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO<br>severe respiratory failure with ECMO | Device: ECMO<br>* the patients with severe respiratory failure were supported by ECMO<br>|
| conventional mechanical ventilation<br>severe respiratory failure with conventional mechanical ventilation | Device: conventional mechanical ventilation<br>* the patients with severe respiratory failure were supported by conventional mechanical ventilation<br>|

What is the study measuring?
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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 |