Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

September 4, 2023 updated by: National Taiwan University Hospital

Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

999

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

    • Taiwan R.
      • Taipei City 100, Taiwan R., Taiwan, 100229
        • Jenghung Wu

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020

Description

Inclusion Criteria:

  • all pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.

Exclusion Criteria:

  • with much missing clinical data

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical mortality
Time Frame: 1 year
hospital expired after operation
1 year
intermediate survival
Time Frame: 5 years
expired during follow-up
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative ICU stay
Time Frame: 1 year
The length of ICU stay after operation
1 year
post-operative intubated days
Time Frame: 1 year
The length of intubated days after operation
1 year

Collaborators and Investigators

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

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)

May 15, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Subscribe