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
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
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Sichuan
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Chengdu, Sichuan, China, 6100041
- Recruiting
- West China Hospital, Sichuan University
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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.
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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.
|
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.
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At least 5-year follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.