Clinical trial NCT03383757: U-TruSignal SpO2 Testing in Neonates
Official title: U-TruSignal SpO2 Testing in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulse Oximetry
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 117
Sex: ALL
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy Root Mean Square (ARMS) Per Data Pair
timeFrame: 30 minutes per data pair
Secondary outcomes:
measure: Continuous SpO2 Measurements During Data Collection Interval
timeFrame: 30 minutes per data pair
Other outcomes:
measure: Type and Number of AEs, SAEs, and Device Issues
timeFrame: 30 minutes per data pair
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital (TAYS)
city: Bangalore
country: India
facility: NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
Study officials:
affiliation: NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
name: Rajiv Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital (TAYS)
name: Outi Tammela, MD
role: PRINCIPAL_INVESTIGATOR
References: