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

NCT ID: NCT02824705

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-05-31

Brief 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.

Conditions

Congenital Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Katri Typpo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katri Typpo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

NIDDK

Identifier Type: -

Identifier Source: org_study_id