Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Extracorporeal Life Support; Neonate

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All neonate recieved ECLS support

Description

Inclusion Criteria:

• ≤28 days of life
• receive ECLS support

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Chinese Neonatal Network
• Investigators: Principal Investigator: Yun Cao, Children's Hospital of Fudan University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Chi-NELS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No