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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Extracorporeal Life Support, Neurodevelopment, Neonate, Mortality, Extracorporeal Membrane Oxygenation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |