Extracorporeal Life Support, Extracorporeal Membrane Oxygenation, Mortality, Neonate, Neurodevelopment
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Chinese Neonatal Network
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality or severe/moderate neurodevelopmental delay at two-year old | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 six months | At six months | — |
| 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 | At six months | Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale |
| Severe/moderate neurodevelopmental delay at one year old | At one year old | Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale |
| Severe/moderate neurodevelopmental delay at two years old | At two years old | Proportion of infants with severe/moderate neurodevelopmental delay according to the development scale |
| Body weight of infants at two years old | At two years old | — |
Outcome results
None listed