Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Withdrawn

• Conditions: Extracorporeal Life Support; Neonate

• Registration Number: NCT05085080
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-20
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ≤28 days of life
• receive ECLS support

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality	From admission to discharge or death, an average of 3 months	Mortality during NICU

Secondary Outcome Measures

Name	Time	Method
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
Incidence of pulmonary hemorrhage	From admission to discharge or dealth, an average of 3 months	Proportion of infants with pulmonary hemorrhage
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 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 cardiac arrhythmia	From admission to discharge or dealth, an average of 3 months	Proportion of infants with cardiac arrhythmia
Length of hospital stay	From admission to discharge or dealth, an average of 3 months	Days of hospitalization
Length of mechanical ventilation	From admission to discharge or dealth, an average of 3 months	Days of mechanical ventilation
Incidence of mechanical complications	During ECLS, an average of 3 months	Complication related to the ECLS circuit
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 CNS infarction	From admission to discharge or dealth, an average of 3 months	Proportion of infants with CNS infarction
Incidence of pneumothorax	From admission to discharge or dealth, an average of 3 months	Proportion of infants with pneumothorax
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..
Incidence of limb ischemia	From admission to discharge or dealth, an average of 3 months	Proportion of infants limb ischemia
Cost of hospital stay	From admission to discharge or dealth, an average of 3 months	All costs during hospitallization
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 intraventricular hemorrhage	From admission to discharge or dealth, an average of 3 months	Proportion of infants with intraventricular hemorrhage
Incidence of hemolysis	From admission to discharge or dealth, an average of 3 months	Proportion of infants with hemolysis