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U-TruSignal SpO2 Testing in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03383757
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : July 1, 2019
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions [50(k)s]: Guidance for Industry and Food and Drug Administration Staff.)

Condition or disease Intervention/treatment Phase
Pulse Oximetry Device: SpO2 Sensor application & blood draw Not Applicable

Detailed Description:

The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device.

The study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor.

After providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject.

The duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: U-TruSignal SpO2 Testing in Neonates
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: SpO2 Sensor Application & Blood draw
All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured
Device: SpO2 Sensor application & blood draw
At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.

Primary Outcome Measures :
  1. Accuracy Root Mean Square (ARMS) per data pair [ Time Frame: 30 minutes per data pair ]
    Compare observations of SpO2 (measured by the test pulse oximeter system) and SaO2 values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood)

Secondary Outcome Measures :
  1. Collection of continuous SpO2 measurements during a defined period of SpO2 data collection from the test pulse oximeter system [ Time Frame: 30 minutes per data pair ]
    The gaps in the measurement of SpO2 values (invalid data) will be calculated during a period of continuous SpO2 data collection with the test pulse oximeter system

Other Outcome Measures:
  1. Type and number of AEs, SAEs, and device issues [ Time Frame: 30 minutes per data pair ]
    Collect safety information, including type and number of AE s, SAEs, and device issues.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 29 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
  2. Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.

Exclusion Criteria:

  1. Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
  2. Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;
  3. Neonates with mean arterial blood pressure < 20mmHg;
  4. Neonates with congenital diaphragmatic hernia; OR
  5. Neonates under High frequency ventilation 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 identifier (NCT number): NCT03383757

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Contact: Cynthia Hines-Sabol 2624221306

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Tampere University Hospital (TAYS) Recruiting
Tampere, Finland, 33520
Contact: Outi Tammela, MD    +358-3-311-66334   
NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center Recruiting
Bangalore, India, 560099
Contact: Rajiv Agarwal, MD    91 80 7122 2360   
Sponsors and Collaborators
GE Healthcare
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Principal Investigator: Rajiv Agarwal, MD NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
Principal Investigator: Outi Tammela, MD Tampere University Hospital (TAYS)

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Responsible Party: GE Healthcare Identifier: NCT03383757     History of Changes
Other Study ID Numbers: 123.04-2017-GES-0002
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 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
Product Manufactured in and Exported from the U.S.: No