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NCT02824705 · ClinicalTrials.gov registry record

Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study

A clinical trial, sponsored by University of Arizona.

Completed
Registry status
53
Enrollment target

NCT02824705: Completed study, sponsored by University of Arizona.

NCT02824705 is a clinical trial that has completed, run by University of Arizona. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02824705 has completed, sponsored by University of Arizona.

COMPLETED
Registry status
53 participants
Enrollment target

Study Summary

Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States. While advances in surgical treatment, cardiac bypass, and post-operative management have improved mortality for children born with heart defects, these children continue to have significant morbidity related to post-operative malnutrition, multiple organ dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity. The purpose of this multi-center observational cohort study is to understand the extent to which practice variation for routine post-operative care might worsen intestinal barrier dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical correction of left sided cardiac obstructive defects. We will enroll 80 children with left sided obstructive congenital cardiac lesions across several US congenital cardiac centers to obtain clinical data and biological specimens. We will leverage existing differences in nutritional and antibiotic strategies at these centers to better understand how intestinal barrier function and the intestinal microbiome may contribute to post-operative multiple organ dysfunction syndrome.

Interventions

  • PROCEDURE Congenital Heart Disease Surgery

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2016-04
Est. Completion 2021-05-31
University of Arizona

349 total trials

What the finished NCT02824705 record still lists

NCT02824705 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Congenital Heart Disease Surgery is the first listed.

NCT02824705 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02824705 about?

NCT02824705 is a clinical study titled "Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study". Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States. While advances in surgical treatment, cardiac bypass, and post-operative management have improved mor...

What is the current status of trial NCT02824705?

This trial is currently completed. The enrollment target is 53 participants. The study started on 2016-04. Estimated completion is 2021-05-31.

What interventions are being tested in trial NCT02824705?

The interventions under investigation include: Congenital Heart Disease Surgery (PROCEDURE).

Who is sponsoring clinical trial NCT02824705?

This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02824705, the US trial registry maintained by the National Library of Medicine. NCT02824705 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.