A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China

Withdrawn

• Conditions: Extracorporeal Life Support; Mortality; Extracorporeal Membrane Oxygenation; Neonate; Neurodevelopment

• Registration Number: NCT05045092
• Lead Sponsor: Children's Hospital of Fudan University

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 Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-16
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31
• Survive to the first ICU discharge

Exclusion Criteria

• Infants who died during the ECLS hospitalization
• Parental refusal to follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality or severe/moderate neurodevelopmental delay at two-year old	At two-year old	It is a binary variable (1/0). If mortality or severe/moderate neurodevelopmental delay occur in the participent, the value of this varible is 1.

Secondary Outcome Measures

Name	Time	Method
Head circumference of infants at two years old	At two years old
Body weight of infants at two years old	At two years old
Head circumference of infants at one year old	At one year old
Length of infants at two years old	At two years old
Severe/moderate neurodevelopmental delay at one year old	At one year old	Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale
Head circumference of infants at six months	At six months
Severe/moderate neurodevelopmental delay at two years old	At two years old	Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale
Body weight of infants at one year old	At one year old
Length of infants at one year old	At one year old
Body weight of infants at six months	At six months
Length of infants at six months	At six months
Severe/moderate neurodevelopmental delay at six months	At six months	Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale