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

NCT02824705 | Completed

• 1 other identifier: NIDDK
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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

Keywords

Heart; multiple organ dysfunction syndrome; pediatric critical care; congenital heart disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline intestinal epithelial barrier biomarker profile

  04/2016-01/31/2020

• Microbiome diversity

  04/2016-01/31/2020

Secondary Outcomes (1)

• Multiple Organ Dysfunction Syndrome

  04/2016-01/31/2020

Interventions

Congenital Heart Disease Surgery PROCEDURE

Stool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention.

Eligibility Criteria

• Age: 3 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of infants and young children who are diagnosed with left sided obstructive congenital heart disease and are scheduled for corrective surgery. Investigators will enroll a total of 80 patients in this multi-center trial. Investigators anticipate that local enrollment will be about 1-2 patients per month, or 12-24 per year when the cardiac program is active.

You may qualify if:

• pre-operative diagnosis of left sided obstructive congenital cardiac defect

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85719, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples, blood samples with permission of family

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Multiple Organ Failure; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Study Officials

• Katri Typpo, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: May 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)