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CompletedNCT05546983Pedia-CardUpdated Dec 14, 2023

How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

An observational study in Congenital Heart Disease in Children, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
189
Ages
1 Year to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Congenital Heart Disease in Children

Keywords

  • Congenital Heart Disease
  • Abnormality in newborns
03

In context

Heart Defects, Congenital

1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.

This study's enrollment of 189 is above the median of 120 across 459 observational studies indexed under Heart Defects, Congenital.

Browse Heart Defects, Congenital studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 989 studies on the registry; 348 are open to participants now.

Browse University Hospital, Strasbourg, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
189 participants (actual)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 site
  • Service de Pédiatrie 1 - CHU de Strasbourg - France
    Strasbourg, 67091, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2022 to primary completion in Jul 2023, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2022
First posted
Sep 21, 2022
StartActual
Sep 1, 2022
Primary completionActual
Jul 1, 2023
CompletionActual
Sep 1, 2023
Last update
Dec 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05546983
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Sep 1, 2022
Primary completion
Jul 1, 2023
Completion
Sep 1, 2023
Last update
Dec 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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