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

Children's Hospital of Fudan University

Overview

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.

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

Conditions

Extracorporeal Life Support Neurodevelopment Neonate Mortality Extracorporeal Membrane Oxygenation

Eligibility

Sex: ALLMin age: 1 HourMax age: 1 Month

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At two-year old

Secondary Outcomes

Body weight of infants at six months

Time frame: At six months

Length of infants at six months

Time frame: At six months

Head circumference of infants at six months

Time frame: At six months

Body weight of infants at one year old

Time frame: At one year old

Length of infants at one year old

Time frame: At one year old

Head circumference of infants at one year old

Time frame: At one year old

Body weight of infants at two years old

Time frame: At two years old

Length of infants at two years old

Time frame: At two years old

Head circumference of infants at two years old

Time frame: At two years old

Severe/moderate neurodevelopmental delay at six months

Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale

Data from ClinicalTrials.gov

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