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.
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.
Study Type
OBSERVATIONAL
Overall mortality
Mortality during NICU
Time frame: From admission to discharge or death, an average of 3 months
Rate of successful weaning from ECLS
Proportion of infants who were successfully weaning from ECLS
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of mechanical complications
Complication related to the ECLS circuit
Time frame: During ECLS, an average of 3 months
Incidence of hemorrhage
Hemorrhage complication including bleeding at gastrointestinal tract, cannulation site, or surgical site
Time frame: 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
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of seizure
Seizure was confirmed by EEG
Time frame: 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)
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of CNS infarction
Proportion of infants with CNS infarction
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of intraventricular hemorrhage
Proportion of infants with intraventricular hemorrhage
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of renal failure
Proportion of infants renal failure
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of CPR required
Proportion of infants required CPR
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of cardiac arrhythmia
Proportion of infants with cardiac arrhythmia
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of pneumothorax
Proportion of infants with pneumothorax
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of pulmonary hemorrhage
Proportion of infants with pulmonary hemorrhage
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of hemolysis
Proportion of infants with hemolysis
Time frame: From admission to discharge or dealth, an average of 3 months
Incidence of limb ischemia
Proportion of infants limb ischemia
Time frame: 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..
Time frame: From admission to discharge or dealth, an average of 3 months
Length of hospital stay
Days of hospitalization
Time frame: From admission to discharge or dealth, an average of 3 months
Cost of hospital stay
All costs during hospitallization
Time frame: From admission to discharge or dealth, an average of 3 months
Length of mechanical ventilation
Days of mechanical ventilation
Time frame: From admission to discharge or dealth, an average of 3 months
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