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

Mortality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05045092
• Other study ID #: F-NELS
• Status: Withdrawn
• Start date: January 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Life Support
• Extracorporeal Membrane Oxygenation
• Mortality
• Neonate
• Neurodevelopment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Chinese Neonatal Network

Outcome

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