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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity

Conditions
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Congenital Disease

Intervention / Treatment
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* Procedure: Congenital Heart Disease Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre-operative diagnosis of left sided obstructive congenital cardiac defect Exclusion Criteria: Corrected gestational age < 37 weeks at time of surgery Short bowel syndrome Intestinal graft vs. host disease Inflammatory Bowel Disease (Ulcerative Colitis, or Crohn's disease) Candidate for intestinal transplant History of necrotizing enterocolitis (NEC) Previous Randomization into this study

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Congenital Heart Disease Surgery|Stool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline intestinal epithelial barrier biomarker profile |  | 04/2016-01/31/2020 | 
| Microbiome diversity |  | 04/2016-01/31/2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple Organ Dysfunction Syndrome |  | 04/2016-01/31/2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart, multiple organ dysfunction syndrome, pediatric critical care, congenital heart disease