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

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.

Study Overview

• Status: Withdrawn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

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 Type: Observational

Contacts and Locations

• Study Contact: Name: Yun Cao, Ph.D. M.D.; Phone Number: +8602164931160; Email: yuncao@fudan.edu.cn
• Study Contact Backup: Name: Siyuan Jiang, Ph.D. M.D.; Phone Number: +8602164931160; Email: jane1350@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Neonates who receive ECLS support within 28 days of life and survive to the first discharge.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality or severe/moderate neurodevelopmental delay 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.	At two-year old

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Collaborators: Chinese Neonatal Network
• Investigators: Principal Investigator: Yun Cao, Ph.D, M.D., Children's Hospital of Fudan University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: F-NELS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No