Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 10:08 AM
Study NCT ID:
NCT05045092
Status:
WITHDRAWN
Last Update Posted:
2024-01-16
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
Sponsor:
Children's Hospital of Fudan University
Organization:
Study Overview
Official Title:
A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.
Detailed Description:
This study aims to describe the six -month, one-year and two-year neurodevelopmental outcomes of survivors of neonatal ECLS treatment in the Chi-NELS. The study population will be neonates who receive ECLS support within 28 days of life and are enrolled in the Chi-NELS. These infants will be prospectively followed for two years. Mortality, growth, and neurodevelopmental outcomes will be assessed at six months, one year and two years.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: