CClinicalTrials.gg
WithdrawnNCT05045092Updated Jan 16, 2024

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

An observational study in Extracorporeal Life Support, Neurodevelopment and Neonate, sponsored by Children's Hospital of Fudan University. Withdrawn. Open to participants aged 1 Hour to 1 Month. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Children's Hospital of Fudan University · Observational

Why this study was withdrawn
lack of funding
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
1 Hour to 1 Month
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Extracorporeal Life Support
  • Neurodevelopment
  • Neonate
  • Mortality
  • Extracorporeal Membrane Oxygenation
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In context

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Hour to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
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What researchers measure

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.

    Time frame: At two-year old

Secondary outcomes

  1. Body weight of infants at six months

    Time frame: At six months

  2. Length of infants at six months

    Time frame: At six months

  3. Head circumference of infants at six months

    Time frame: At six months

  4. Body weight of infants at one year old

    Time frame: At one year old

  5. Length of infants at one year old

    Time frame: At one year old

  6. Head circumference of infants at one year old

    Time frame: At one year old

  7. Body weight of infants at two years old

    Time frame: At two years old

  8. Length of infants at two years old

    Time frame: At two years old

  9. Head circumference of infants at two years old

    Time frame: At two years old

  10. Severe/moderate neurodevelopmental delay at six months

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

    Time frame: At six months

  11. Severe/moderate neurodevelopmental delay at one year old

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

    Time frame: At one year old

  12. Severe/moderate neurodevelopmental delay at two years old

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

    Time frame: At two years old

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05045092
Lead sponsor
Children's Hospital of Fudan University
Collaborators
Chinese Neonatal Network
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Jan 1, 2024 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 16, 2024

Study contacts

Yun Cao, Ph.D, M.D.
principal investigator · Children's Hospital of Fudan University, Shanghai, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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