Extracorporeal Life Support, Neonate
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Chinese Neonatal Network
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Months
Healthy volunteers
No
Inclusion criteria
* ≤28 days of life * receive ECLS support
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | From admission to discharge or death, an average of 3 months | Mortality during NICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mechanical complications | During ECLS, an average of 3 months | Complication related to the ECLS circuit |
| Incidence of hemorrhage | From admission to discharge or dealth, an average of 3 months | Hemorrhage complication including bleeding at gastrointestinal tract, cannulation site, or surgical site |
| Incidence of brain death | From admission to discharge or dealth, an average of 3 months | Brain death is diagnosed according to the definition published on critical care medcine in 2011 |
| Incidence of seizure | From admission to discharge or dealth, an average of 3 months | Seizure was confirmed by EEG |
| Incidence of diffuse ischemia of central nervous system (CNS) | From admission to discharge or dealth, an average of 3 months | Proportion of infants with diffuse ischemia of central nervous system (CNS) |
| Incidence of CNS infarction | From admission to discharge or dealth, an average of 3 months | Proportion of infants with CNS infarction |
| Incidence of intraventricular hemorrhage | From admission to discharge or dealth, an average of 3 months | Proportion of infants with intraventricular hemorrhage |
| Incidence of renal failure | From admission to discharge or dealth, an average of 3 months | Proportion of infants renal failure |
| Incidence of CPR required | From admission to discharge or dealth, an average of 3 months | Proportion of infants required CPR |
| Rate of successful weaning from ECLS | From admission to discharge or dealth, an average of 3 months | Proportion of infants who were successfully weaning from ECLS |
| Incidence of pneumothorax | From admission to discharge or dealth, an average of 3 months | Proportion of infants with pneumothorax |
| Incidence of pulmonary hemorrhage | From admission to discharge or dealth, an average of 3 months | Proportion of infants with pulmonary hemorrhage |
| Incidence of hemolysis | From admission to discharge or dealth, an average of 3 months | Proportion of infants with hemolysis |
| Incidence of limb ischemia | From admission to discharge or dealth, an average of 3 months | Proportion of infants limb ischemia |
| Incidence of infection | From admission to discharge or dealth, an average of 3 months | Infection include pneumonia, sepsis, urinary tract infection, central nervous system infection etc.. |
| Length of hospital stay | From admission to discharge or dealth, an average of 3 months | Days of hospitalization |
| Cost of hospital stay | From admission to discharge or dealth, an average of 3 months | All costs during hospitallization |
| Length of mechanical ventilation | From admission to discharge or dealth, an average of 3 months | Days of mechanical ventilation |
| Incidence of cardiac arrhythmia | From admission to discharge or dealth, an average of 3 months | Proportion of infants with cardiac arrhythmia |
Outcome results
None listed