How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ? (Pedia-Card)

December 13, 2023 updated by: University Hospital, Strasbourg, France
Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

189

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Pédiatrie 1 - CHU de Strasbourg - France

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 year to 17 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Minor patients, under the age of 18 operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure

Description

Inclusion criteria:

  • Minor patients, under the age of 18
  • operated at the HUS between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without CIV; or isolated ventricular septal closure
  • Child or holders of parental authority who do not object to the reuse of their data for scientific research purposes.

Exclusion criteria:

  • Transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation
  • Surgical technique different from the arterial switch for the transpositions of the great vessels
  • Closure of interventricular communication associated with another complex heart malformation (tetralogy of Fallot, atrioventricular canal, right ventricle with double outlet, etc.)
  • Child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.

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
Time Frame
Retrospective analysis of the quality criteria described in the literature after pediatric cardiac surgery by studying their behavior within a local cohort within the University Hospitals of Strasbourg
Time Frame: Files analysed retrospectively from January 01, 2010 to March 31, 2022 will be examined
Files analysed retrospectively from January 01, 2010 to March 31, 2022 will be examined

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

September 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8717 (Duke Legacy IRB Number)

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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