Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS)

NCT05085080 | Withdrawn

• 1 other identifier: Chi-NELS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Extracorporeal Life Support; Neonate

Outcome Measures

Primary Outcomes (1)

• Overall mortality

  Mortality during NICU

  From admission to discharge or death, an average of 3 months

Secondary Outcomes (19)

• Rate of successful weaning from ECLS

  From admission to discharge or dealth, an average of 3 months

• Incidence of mechanical complications

  During ECLS, an average of 3 months

• Incidence of hemorrhage

  From admission to discharge or dealth, an average of 3 months

• Incidence of brain death

  From admission to discharge or dealth, an average of 3 months

• Incidence of seizure

  From admission to discharge or dealth, an average of 3 months

Eligibility Criteria

• Age: 1 Hour - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All neonate recieved ECLS support

You may qualify if:

• ≤28 days of life
• receive ECLS support

You may not qualify if:

• none

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Chinese Neonatal Network: collaborator

Study Officials

• Yun Cao

  Children's Hospital of Fudan University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 20, 2021
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01