Clinical trial NCT05085080: Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
Official title: Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Extracorporeal Life Support
Neonate
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Neonatal Network
First posted: 2021-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonate recieved ECLS support

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.

Eligibility criteria: Inclusion Criteria:

* ≤28 days of life
* receive ECLS support

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall mortality
timeFrame: From admission to discharge or death, an average of 3 months
Secondary outcomes:
measure: Rate of successful weaning from ECLS
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of mechanical complications
timeFrame: During ECLS, an average of 3 months
measure: Incidence of hemorrhage
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of brain death
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of seizure
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of diffuse ischemia of central nervous system (CNS)
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of CNS infarction
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of intraventricular hemorrhage
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of renal failure
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of CPR required
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of cardiac arrhythmia
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of pneumothorax
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of pulmonary hemorrhage
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of hemolysis
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of limb ischemia
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Incidence of infection
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Length of hospital stay
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Cost of hospital stay
timeFrame: From admission to discharge or dealth, an average of 3 months
measure: Length of mechanical ventilation
timeFrame: From admission to discharge or dealth, an average of 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University, Shanghai, China
name: Yun Cao
role: PRINCIPAL_INVESTIGATOR
References: