Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Neonate Clinical Trial

Official title:

Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05085080
• Other study ID #: Chi-NELS
• Status: Withdrawn
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Month

Eligibility

Inclusion Criteria:

• =28 days of life
• receive ECLS support

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Extracorporeal Life Support
• Neonate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Chinese Neonatal Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	Mortality during NICU	From admission to discharge or death, an average of 3 months
Secondary	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
Secondary	Incidence of mechanical complications	Complication related to the ECLS circuit	During ECLS, an average of 3 months
Secondary	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
Secondary	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
Secondary	Incidence of seizure	Seizure was confirmed by EEG	From admission to discharge or dealth, an average of 3 months
Secondary	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
Secondary	Incidence of CNS infarction	Proportion of infants with CNS infarction	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of intraventricular hemorrhage	Proportion of infants with intraventricular hemorrhage	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of renal failure	Proportion of infants renal failure	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of CPR required	Proportion of infants required CPR	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of cardiac arrhythmia	Proportion of infants with cardiac arrhythmia	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of pneumothorax	Proportion of infants with pneumothorax	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of pulmonary hemorrhage	Proportion of infants with pulmonary hemorrhage	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of hemolysis	Proportion of infants with hemolysis	From admission to discharge or dealth, an average of 3 months
Secondary	Incidence of limb ischemia	Proportion of infants limb ischemia	From admission to discharge or dealth, an average of 3 months
Secondary	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
Secondary	Length of hospital stay	Days of hospitalization	From admission to discharge or dealth, an average of 3 months
Secondary	Cost of hospital stay	All costs during hospitallization	From admission to discharge or dealth, an average of 3 months
Secondary	Length of mechanical ventilation	Days of mechanical ventilation	From admission to discharge or dealth, an average of 3 months