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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05045092
Other study ID # F-NELS
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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