Congenital Heart DiseaseNCT04056104
Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements
A study testing SpO2 and PIx Measurement in people with Congenital Heart Disease, run by University of California, Davis at 6 sites in United States.
Trial summary
The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- SpO2 and PIx Measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Oct 2019to 12 Dec 2021
- Phase
- Interventional
- 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 Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age < 22 days
- and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.
Who cannot join
- For Controls: Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD"
- For Newborns with confirmed/suspected CHD: a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Northwell Health
New Hyde Park, New York, 11040
Sutter Institute for Medical Research
Sacramento, California, 95816
University of California-Davis
Sacramento, California, 95817
University of Utah/Primary Children's Hospital
Salt Lake City, Utah, 84113
UCSF Benioff Children's Hospital
San Francisco, California, 94158
About this study
The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.
Read the detailed description
This study will create and test an enhanced critical congenital heart defect (CCHD) screen that combines non-invasive measurements of oxygenation and perfusion in two ways. The first will use current equipment without automated interpretation and the second will require additional software/device but will automate the interpretation. To work towards development of those two algorithms in this stage of the study, the study team will download oxygen saturation (SpO2) and perfusion index (PIx) measurements from newborns with and without congenital heart disease (CHD) and apply statistical tests to the data afterwards to identify parameters to include in the newly developed screening algorithms. The overall objective is to create an automated screening algorithm to improve acyanotic CCHD detection, preventing morbidity and mortality associated with diagnoses missed by SpO2 screening. The central hypothesis is that the addition of non-invasive perfusion measurements to SpO2 will be superior to SpO2-alone screening for detection of acyanotic CCHD. The data collected during this study will be used to develop the two algorithms and the algorithms will be compared to the standard of care using statistical tests on the data after the fact (k-fold validation). The newly developed algorithms will not be tested in-situ on patients during this study.
- Conditions
- Congenital Heart Disease
- Being tested
- SpO2 and PIx Measurement
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 and PIx MeasurementDiagnostic test
Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured
| Study group | Role | What they receive |
|---|---|---|
| SpO2 and PIx Measurement | Experimental | Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters Receives: Diagnostic Test: SpO2 and PIx Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristics (AUROC) of critical congenital heart defect (CCHD) screening algorithm for CCHD with systemic obstruction from coarctation of the aorta or interrupted aortic arch
A CCHD screening algorithm will be created by simultaneously measuring oxygen saturation, perfusion index, and pulse oximetry waveform analysis from right upper and any lower extremity in newborns with and without CHD. Investigators will use cross-validation to test the newly developed algorithms and estimate AUROC for the specified types of heart defects. For purposes of defining primary and secondary criterion variables, the CHD will be considered present or absent at enrollment when the infant is less than 22 days of age according to the latest diagnostic assessment available for the infant (echocardiogram and/or physical examination). Because some CHDs can be diagnosed at later dates despite earlier negative diagnostic evaluations, investigators will reconfirm the presence or absence of the outcome at a minimum of 6 weeks of age for all patients except those who die or are lost to follow-up.
Measured: At enrollment
Secondary outcomes (3)
AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD)
AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD). CCHD will be defined as an anatomical heart defect that requires surgical or catheter-based corrective/palliative procedure in the first 30 days after birth
Measured: At 30 days of life
AUROC of CCHD screening algorithm for critical congenital heart defect (CCHD) with any systemic obstruction
AUROC of CCHD screening algorithm for critical congenital heart defect (CCHD) with any systemic obstruction
Measured: At enrollment
AUROC of CCHD screening algorithm for any congenital heart defect (CHD)
AUROC of CCHD screening algorithm for any congenital heart defect (CHD). CHD will be defined as any anatomical heart with the exception of isolated patent ductus arteriosus and/or atrial septal defect/patent foramen ovale
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start23 Oct 2019
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-invasive measurements of oxygenation and perfusion will be measured with pulse oximeters
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056104
- Sponsor's protocol ID
- 1386243
- Other IDs
- 5KL2TR001859-04, R21HD099239-01
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2019
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siefkes H, Oliveira LC, Koppel R, Hogan W, Garg M, Manalo E, Cresalia N, Lai Z, Tancredi D, Lakshminrusimha S, Chuah CN. Machine Learning-Based Critical Congenital Heart Disease Screening Using Dual-Site Pulse Oximetry Measurements. J Am Heart Assoc. 2024 Jun 18;13(12):e033786. doi: 10.1161/JAHA.123.033786. Epub 2024 Jun 15.
PubMed 38879455
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements
- ClinicalTrials.gov ID
- NCT04056104
- Acronym / sponsor ID
- 1386243
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Oct 2019 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 14 Aug 2019 (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 purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.
Detailed description
This study will create and test an enhanced critical congenital heart defect (CCHD) screen that combines non-invasive measurements of oxygenation and perfusion in two ways. The first will use current equipment without automated interpretation and the second will require additional software/device but will automate the interpretation. To work towards development of those two algorithms in this stage of the study, the study team will download oxygen saturation (SpO2) and perfusion index (PIx) measurements from newborns with and without congenital heart disease (CHD) and apply statistical tests to the data afterwards to identify parameters to include in the newly developed screening algorithms. The overall objective is to create an automated screening algorithm to improve acyanotic CCHD detection, preventing morbidity and mortality associated with diagnoses missed by SpO2 screening. The central hypothesis is that the addition of non-invasive perfusion measurements to SpO2 will be superior to SpO2-alone screening for detection of acyanotic CCHD. The data collected during this study will be used to develop the two algorithms and the algorithms will be compared to the standard of care using statistical tests on the data after the fact (k-fold validation). The newly developed algorithms will not be tested in-situ on patients during this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-invasive measurements of oxygenation and perfusion will be measured with pulse oximeters
| Arm | Type | Receives |
|---|---|---|
| SpO2 and PIx Measurement | Experimental | Diagnostic Test: SpO2 and PIx MeasurementNon-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age < 22 days
- and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.
Key exclusion criteria (2 listed)
- For Controls: Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD"
- For Newborns with confirmed/suspected CHD: a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.
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 |
|---|---|---|
| SpO2 and PIx MeasurementRight upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured | Diagnostic test | SpO2 and PIx Measurement |
Primary outcome
Area Under the Receiver Operating Characteristics (AUROC) of critical congenital heart defect (CCHD) screening algorithm for CCHD with systemic obstruction from coarctation of the aorta or interrupted aortic arch
Time frame: At enrollment
A CCHD screening algorithm will be created by simultaneously measuring oxygen saturation, perfusion index, and pulse oximetry waveform analysis from right upper and any lower extremity in newborns with and without CHD. Investigators will use cross-validation to test the newly developed algorithms and estimate AUROC for the specified types of heart defects. For purposes of defining primary and secondary criterion variables, the CHD will be considered present or absent at enrollment when the infant is less than 22 days of age according to the latest diagnostic assessment available for the infant (echocardiogram and/or physical examination). Because some CHDs can be diagnosed at later dates despite earlier negative diagnostic evaluations, investigators will reconfirm the presence or absence of the outcome at a minimum of 6 weeks of age for all patients except those who die or are lost to follow-up.
3 secondary outcomes
AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD)
Time frame: At 30 days of life
AUROC of CCHD screening algorithm for critical congenital heart defect (CCHD) with any systemic obstruction
Time frame: At enrollment
AUROC of CCHD screening algorithm for any congenital heart defect (CHD)
Time frame: At enrollment
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 3 Feb 2022.
- Derived from this study: PubMed 38879455Siefkes H, Oliveira LC, Koppel R, Hogan W, Garg M, Manalo E, Cresalia N, Lai Z, Tancredi D, Lakshminrusimha S, Chuah CN. Machine Learning-Based Critical Congenital Heart Disease Screening Using Dual-Site Pulse Oximetry Measurements. J Am Heart Assoc. 2024 Jun 18;13(12):e033786. doi: 10.1161/JAHA.123.033786. Epub 2024 Jun 15.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpO2 and PIx Measurement in people with Congenital Heart Disease, run by University of California, Davis at 6 sites 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 2 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Area Under the Receiver Operating Characteristics (AUROC) of critical congenital heart defect (CCHD) screening algorithm for CCHD with systemic obstruction from coarctation of the aorta or interrupted aortic arch (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04056104, which also lists 1 linked publication.
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 3 Feb 2022.