NCT05181423

Brief Summary

To identify the potential serum and radiological biomarkers with regard to neonates undergoing abdominal surgery, and to further evaluate the prognostic value of these markers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

December 19, 2021

Last Update Submit

January 5, 2022

Conditions

BiomarkersNeonate

Outcome Measures

Primary Outcomes (1)

  • Value of non-invasive biomarkers

    These markers will be collected in association with the prognostication for neonates before and after surgery.

    At least 5-year follow up

Study Arms (2)

Retrospective cohort

The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.

Other: Biomarkers

Prospective cohort

The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.

Other: Biomarkers

Interventions

BiomarkersOTHER

Different serum and radiological biomarkers neonates undergoing abdominal surgery.

Prospective cohortRetrospective cohort

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Neonates undergoing abdominal surgery.

You may qualify if:

  • Age up to 18 years old
  • With written informed consent

You may not qualify if:

  • Clinical data missing
  • Without written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 6100041, China

RECRUITING

MeSH Terms

Interventions

Biomarkers

Intervention Hierarchy (Ancestors)

Biological Factors

Central Study Contacts

Yuhan Yang, MD

CONTACT

8613258389785yyh_1023@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 19, 2021

First Posted

January 6, 2022

Study Start

January 1, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)