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OpenTrials
Completed

NCT Number: NCT05546983

How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

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.

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Key information

Conditions

Congenital Heart Disease in Children Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: Pedia-Card

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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