Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Study Overview
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Brief Summary
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Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique which provides respiratory and cardiac support to patients with respiratory and/or heart failure. Neonates account for a significant proportion of patients requiring ECLS support. While with unique pathophysiology among newborn infants, neonatal ECLS treatment faces different challenges (such as specific indications, anticoagulation, hemodynamic management, high incidences of complications, ect.) from those of elder children or adults. Though neonatal ECMO has been used in developed countries since 1970s, the introduction of neonatal ECMO in China was not reported until 2010s. While on the other hand, there has been a rapid increase of neonatal ECLS cases and centers in China in the past decade with a huge variation of numbers of cases and quality among different centers. Therefore, there is an urgent need to monitor the use and quality of neonatal ECLS in China. The goal of the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) is to maintain a registry of use of ECLS in active neonatal ECLS centers across China, to support quality improvement of neonatal ELCS, clinical research and regulatory agencies.

Detailed Description
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This study aims to establish a neonatal ECLS network of all active ECLS centers in China to facilitate standardization of care and collaborative research. On the basis of the network, this prospective comprehensive registry will enroll all neonates who receive ECLS support in participating centers. The indications, managements, complications and outcomes of neonatal ECLS in China will be described in detail, to monitor the development of neonatal ECLS in China, to identify targets for quality improvement, to assist in reducing mortality and morbidity of neonates requiring ECLS support, and to facilitate innovative clinical researches.

Official Title
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Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Conditions
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Extracorporeal Life Support, Neonate

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≤28 days of life receive ECLS support Exclusion Criteria: none

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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | Mortality during NICU | From admission to discharge or death, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful weaning from ECLS | Proportion of infants who were successfully weaning from ECLS | From admission to discharge or dealth, an average of 3 months | 
| Incidence of mechanical complications | Complication related to the ECLS circuit | During ECLS, an average of 3 months | 
| Incidence of hemorrhage | Hemorrhage complication including bleeding at gastrointestinal tract, cannulation site, or surgical site | From admission to discharge or dealth, an average of 3 months | 
| Incidence of brain death | Brain death is diagnosed according to the definition published on critical care medcine in 2011 | From admission to discharge or dealth, an average of 3 months | 
| Incidence of seizure | Seizure was confirmed by EEG | From admission to discharge or dealth, an average of 3 months | 
| Incidence of diffuse ischemia of central nervous system (CNS) | Proportion of infants with diffuse ischemia of central nervous system (CNS) | From admission to discharge or dealth, an average of 3 months | 
| Incidence of CNS infarction | Proportion of infants with CNS infarction | From admission to discharge or dealth, an average of 3 months | 
| Incidence of intraventricular hemorrhage | Proportion of infants with intraventricular hemorrhage | From admission to discharge or dealth, an average of 3 months | 
| Incidence of renal failure | Proportion of infants renal failure | From admission to discharge or dealth, an average of 3 months | 
| Incidence of CPR required | Proportion of infants required CPR | From admission to discharge or dealth, an average of 3 months | 
| Incidence of cardiac arrhythmia | Proportion of infants with cardiac arrhythmia | From admission to discharge or dealth, an average of 3 months | 
| Incidence of pneumothorax | Proportion of infants with pneumothorax | From admission to discharge or dealth, an average of 3 months | 
| Incidence of pulmonary hemorrhage | Proportion of infants with pulmonary hemorrhage | From admission to discharge or dealth, an average of 3 months | 
| Incidence of hemolysis | Proportion of infants with hemolysis | From admission to discharge or dealth, an average of 3 months | 
| Incidence of limb ischemia | Proportion of infants limb ischemia | From admission to discharge or dealth, an average of 3 months | 
| Incidence of infection | Infection include pneumonia, sepsis, urinary tract infection, central nervous system infection etc.. | From admission to discharge or dealth, an average of 3 months | 
| Length of hospital stay | Days of hospitalization | From admission to discharge or dealth, an average of 3 months | 
| Cost of hospital stay | All costs during hospitallization | From admission to discharge or dealth, an average of 3 months | 
| Length of mechanical ventilation | Days of mechanical ventilation | From admission to discharge or dealth, an average of 3 months |