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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05085080
Other study ID # Chi-NELS
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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