Congenital Heart Disease in ChildrenNCT04604418
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
An observational study of Congenital Heart Disease in Children, run by Boston Children's Hospital at 10 sites in 2 countries.
Trial summary
The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Congenital Heart Disease in Children
- How many people
- 10,000 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 1 Oct 2020to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study. All patients will be included.
Who may be able to join
- Males or females ages birth to 21 years.
- Patients diagnosed with congenital heart disease
- Patients undergoing a noncardiac procedure (surgical or nonsurgical)
Who cannot join
- Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
- Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 5 recruiting
- Active, not recruiting
Children's Healthcare of Atlanta - Egleston Hospita
Atlanta, Georgia, 30322
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Viviane Nasr, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Wanda Miller Hance
- Active, not recruiting
University of California, Los Angeles
Los Angeles, California, 90095
- Active, not recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Michael Kuntz, MD, 615-322-5000, michael.kuntz@vumc.org
- Terminated
Children's Hospital of the King's Daughter
Norfolk, Virginia, 23507
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Susan Nicolson
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20310
Nina Deutsch, MD
Canada1 site, 1 recruiting
- Recruiting
Hospital for Sick Kids
Toronto, Ontario, M5G 1X8
Vannessa Chin, MD, 416-813-7445, vannessa.chin@sickkids.ca
About this study
The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.
However, the information provided by national databases lack granularity and the information from single institutional data is limited.
This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.
- Conditions
- Congenital Heart Disease in Children
- Being tested
- No intervention. It is observational
- Keywords
- Perioperative risk prediction, Adverse Postoperative Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. It is observationalOther
No intervention. It is observational
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death
Measured: during the procedure and up to 30-days following the procedure
Intensive Care Unit admission
The postoperative location of the patient is in the intensive care unit unexpectedly
Measured: following the procedure and up to 72 hours
Postoperative mechanical support
Patient required a ventilator or noninvasive positive pressure ventilation
Measured: following the procedure and up to 72 hours
Intraoperative cardiac event
Measured: During the perioperative period
Secondary outcomes (4)
Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours
Patient was discharged after the procedure and needed to be readmitted to the hospital is defined as readmission
Measured: following the procedure and up to 72 hours
Cardiac arrest
Patient required cardiopulmonary ressuscitation
Measured: during the procedure and up to 72 hours
Neurologic injury
Defined as stroke or seizure by the provider
Measured: Following the procedure and up to 72 hours
Renal Injury
Defined based on creatinine and glomerular filtration
Measured: Following the procedure and up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Oct 2020
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 10,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Vanderbilt University Medical Center, University of Minnesota, Children's Hospital of Philadelphia, Children's Healthcare of Atlanta, Baylor College of Medicine, Children's National Research Institute, Children's Hospital of The King's Daughters, University of California, Los Angeles
- Responsible party
- Principal investigator, Viviane Nasr, Boston Children's Hospital
- Investigators
- Viviane Nasr, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604418
- Sponsor's protocol ID
- IRB-P00035008
- Status last verified
- Apr 2026
- First submitted
- 16 Oct 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
- ClinicalTrials.gov ID
- NCT04604418
- Acronym / sponsor ID
- IRB-P00035008
- Conditions
- Congenital Heart Disease in Children
- Keywords
- Perioperative risk prediction, Adverse Postoperative Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Vanderbilt University Medical Center, University of Minnesota, Children's Hospital of Philadelphia, Children's Healthcare of Atlanta, Baylor College of Medicine, Children's National Research Institute, Children's Hospital of The King's Daughters, University of California, Los Angeles
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Oct 2020 (actual)
- 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.
The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.
However, the information provided by national databases lack granularity and the information from single institutional data is limited.
This project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients diagnosed with congenital heart disease and presenting to the participating institution for a noncardiac procedure are included in the study. All patients will be included.
Key inclusion criteria (3 listed)
- Males or females ages birth to 21 years.
- Patients diagnosed with congenital heart disease
- Patients undergoing a noncardiac procedure (surgical or nonsurgical)
Key exclusion criteria (2 listed)
- Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.
- Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study
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 |
|---|---|---|
| No intervention. It is observationalNo intervention. It is observational | Other | – |
Primary outcome
Mortality
Time frame: during the procedure and up to 30-days following the procedure
Death
Intensive Care Unit admission
Time frame: following the procedure and up to 72 hours
The postoperative location of the patient is in the intensive care unit unexpectedly
Postoperative mechanical support
Time frame: following the procedure and up to 72 hours
Patient required a ventilator or noninvasive positive pressure ventilation
Intraoperative cardiac event
Time frame: During the perioperative period
4 secondary outcomes
Readmission Cardiac arrest: during the procedure and up to 72 hours Neurologic injury (stroke, seizure) following the procedure and up to 72 hours Renal injury following the procedure and up to 72 hours
Time frame: following the procedure and up to 72 hours
Cardiac arrest
Time frame: during the procedure and up to 72 hours
Neurologic injury
Time frame: Following the procedure and up to 72 hours
Renal Injury
Time frame: Following the procedure and up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
Viviane Nasr, MD principal investigator
Boston Children's Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children, run by Boston Children's Hospital at 10 sites in 2 countries.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane Nasr, MD (617-355-6225, viviane.nasr@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: during the procedure and up to 30-days following the procedure). The study lists 4 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 7 Apr 2026.