Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

January 11, 2024 updated by: Children's Hospital of Fudan University
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Siyuan Jiang, Ph.D. M.D.
  • Phone Number: +8602164931160
  • Email: jane1350@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: From admission to discharge or death, an average of 3 months
Mortality during NICU
From admission to discharge or death, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of successful weaning from ECLS
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants who were successfully weaning from ECLS
From admission to discharge or dealth, an average of 3 months
Incidence of mechanical complications
Time Frame: During ECLS, an average of 3 months
Complication related to the ECLS circuit
During ECLS, an average of 3 months
Incidence of hemorrhage
Time Frame: From admission to discharge or dealth, an average of 3 months
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
Time Frame: 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
From admission to discharge or dealth, an average of 3 months
Incidence of seizure
Time Frame: From admission to discharge or dealth, an average of 3 months
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)
Time Frame: From admission to discharge or dealth, an average of 3 months
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
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with CNS infarction
From admission to discharge or dealth, an average of 3 months
Incidence of intraventricular hemorrhage
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with intraventricular hemorrhage
From admission to discharge or dealth, an average of 3 months
Incidence of renal failure
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants renal failure
From admission to discharge or dealth, an average of 3 months
Incidence of CPR required
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants required CPR
From admission to discharge or dealth, an average of 3 months
Incidence of cardiac arrhythmia
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with cardiac arrhythmia
From admission to discharge or dealth, an average of 3 months
Incidence of pneumothorax
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with pneumothorax
From admission to discharge or dealth, an average of 3 months
Incidence of pulmonary hemorrhage
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with pulmonary hemorrhage
From admission to discharge or dealth, an average of 3 months
Incidence of hemolysis
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants with hemolysis
From admission to discharge or dealth, an average of 3 months
Incidence of limb ischemia
Time Frame: From admission to discharge or dealth, an average of 3 months
Proportion of infants limb ischemia
From admission to discharge or dealth, an average of 3 months
Incidence of infection
Time Frame: From admission to discharge or dealth, an average of 3 months
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
Time Frame: From admission to discharge or dealth, an average of 3 months
Days of hospitalization
From admission to discharge or dealth, an average of 3 months
Cost of hospital stay
Time Frame: From admission to discharge or dealth, an average of 3 months
All costs during hospitallization
From admission to discharge or dealth, an average of 3 months
Length of mechanical ventilation
Time Frame: From admission to discharge or dealth, an average of 3 months
Days of mechanical ventilation
From admission to discharge or dealth, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese Neonatal Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yun Cao, Children's Hospital of Fudan University, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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