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

NCT ID: NCT05045092

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2027-12-31

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.

Conditions

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Extracorporeal Life Support Neurodevelopment Neonate Mortality Extracorporeal Membrane Oxygenation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Neonatal Network

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Cao, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University, Shanghai, China

Other Identifiers

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F-NELS

Identifier Type: -

Identifier Source: org_study_id

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