Congenital DiseaseNCT02824705
Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study
An observational study of Congenital Disease, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 days to 2 years
- Conditions the study is for
- Congenital Disease
- What is being tested?
- Congenital Heart Disease Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- pre-operative diagnosis of left sided obstructive congenital cardiac defect
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity
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
- Being tested
- Congenital Heart Disease Surgery
- Keywords
- Heart, multiple organ dysfunction syndrome, pediatric critical care, congenital heart disease
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Multiple Organ Failure, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congenital Heart Disease SurgeryProcedure or 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline intestinal epithelial barrier biomarker profile
Measured: 04/2016-01/31/2020
Microbiome diversity
Measured: 04/2016-01/31/2020
Secondary outcomes (1)
Multiple Organ Dysfunction Syndrome
Measured: 04/2016-01/31/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startApr 2016
- Primary completion1 Jan 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katri Typpo, University of Arizona
- Investigators
- Katri Typpo, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824705
- Sponsor's protocol ID
- NIDDK
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2016
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity
- ClinicalTrials.gov ID
- NCT02824705
- Acronym / sponsor ID
- NIDDK
- Conditions
- Congenital Disease
- Keywords
- Heart, multiple organ dysfunction syndrome, pediatric critical care, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- pre-operative diagnosis of left sided obstructive congenital cardiac defect
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congenital Heart Disease SurgeryStool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention. | Procedure or surgery | – |
Primary outcome
Change from baseline intestinal epithelial barrier biomarker profile
Time frame: 04/2016-01/31/2020
Microbiome diversity
Time frame: 04/2016-01/31/2020
1 secondary outcome
Multiple Organ Dysfunction Syndrome
Time frame: 04/2016-01/31/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Congenital Disease
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katri Typpo, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disease, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline intestinal epithelial barrier biomarker profile (time frame: 04/2016-01/31/2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.