NCT05045092

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
20mo left

Started Jan 2024

Longer than P75 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
2.3 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

4 years

First QC Date

September 6, 2021

Last Update Submit

January 11, 2024

Conditions

Extracorporeal Life SupportNeurodevelopmentNeonateMortalityExtracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • +7 more secondary outcomes

Eligibility Criteria

Age1 Hour - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates who receive ECLS support within 28 days of life and survive to the first discharge.

You may qualify if:

  • 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

You may not qualify if:

  • Infants who died during the ECLS hospitalization
  • Parental refusal to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yun Cao, Ph.D, M.D.

    Children's Hospital of Fudan University, Shanghai, China

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share