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

Congenital Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824705
• Other study ID #: NIDDK
• Status: Completed
• Start date: April 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 31, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline intestinal epithelial barrier biomarker profile		04/2016-01/31/2020
Primary	Microbiome diversity		04/2016-01/31/2020
Secondary	Multiple Organ Dysfunction Syndrome		04/2016-01/31/2020