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Trial record 10 of 12 for:    Atrial Septal Defect 5

Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

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ClinicalTrials.gov Identifier: NCT04056104
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Diagnostic Test: SpO2 and PIx Measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Non-invasive measurements of oxygenation and perfusion will be measured with pulse oximeters
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: SpO2 and PIx Measurement
Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters
Diagnostic Test: SpO2 and PIx Measurement
Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured




Primary Outcome Measures :
  1. 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 8 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.


Secondary Outcome Measures :
  1. 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 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

  2. 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 critical congenital heart defect (CCHD) with any systemic obstruction

  3. AUROC of CCHD screening algorithm for any congenital heart defect (CHD) [ Time Frame: At enrollment ]
    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



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 8 days
  • and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed with CHD.

Exclusion Criteria:

  • Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects
  • Corrective surgical or catheter intervention performed before enrollment
  • Current infusions of vasoactive medications other than prostaglandin therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056104


Contacts
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Contact: Heather Siefkes, MD 503-487-7181 hsiefkes@ucdavis.edu
Contact: Hadley Sauers-Ford, MPH 916-734-4729 hsauersford@ucdavis.edu

Locations
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United States, California
David Geffen School of Medicine at UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Gary Satou, MD    310-267-7667    GSatou@mednet.ucla.edu   
Principal Investigator: Gary Satou, MD         
Sutter Institute for Medical Research Not yet recruiting
Sacramento, California, United States, 95816
Contact: Linda D Marks, MPA-H, CCRP    916-887-4733    marksl1@sutterhealth.org   
University of California-Davis
Sacramento, California, United States, 95817
UCSF Benioff Children's Hospital Not yet recruiting
San Francisco, California, United States, 94158
Contact: Whitnee Hogan, MD       Whitnee.Hogan@ucsf.edu   
Principal Investigator: Whitnee Hogan, MD         
United States, New York
Northwell Health Not yet recruiting
New Hyde Park, New York, United States, 11040
Contact: Debra Potak, RN    516-838-6436    DPotak@northwell.edu   
Principal Investigator: Robert Koppel, MD         
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04056104     History of Changes
Other Study ID Numbers: 1386243
5KL2TR001859-04 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities