Identification of Noninvasive Biomarkers for Neonates Undergoing Abdominal Surgery

January 5, 2022 updated by: Yuhan Yang, West China Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

First, the investigators will collect serum biomarkers in neonate patients receiving abdominal surgery. Then the investigators will identify the characteristics and change of biomarkers expressed in neonate patients before and after abdominal surgery. The investigators will further evaluate the prognostic value of these markers for neonate patients receiving abdominal surgery.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 6100041
        • Recruiting
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates undergoing abdominal surgery.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Clinical data missing
  • Without written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Different serum and radiological biomarkers neonates undergoing abdominal surgery.
Prospective cohort
The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.
Other: Biomarkers
Different serum and radiological biomarkers neonates undergoing abdominal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value of non-invasive biomarkers
Time Frame: At least 5-year follow up
These markers will be collected in association with the prognostication for neonates before and after surgery.
At least 5-year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

December 19, 2021

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • HX-2021657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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