Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Condition(s) studied

Investigational drug(s) / intervention(s)

Wireless skin sensors vital sign monitoring system: The wireless monitoring system will be applied to the newborn and consist of a chest sensor (Anne Arc by Sibel Inc.) and a RAD-7 (Masimo)pulse oximeter limb sensor.

Wired vital sign monitoring system: A standard ECG and SpO2 monitoring device will be applied suing the Infinity M540 monitor (Draeger, Germany). The chest sensor will be placed as per standard of care on the newborn's chest and abdomen, and the SpO2 sensor on their hands or feet.

Study summary

The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:

1. Assess feasibility
2. Evaluate safety
3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.

Eligibility

Primary outcome measure(s)

• Feasibility of using a wireless monitoring system immediately after delivery for HR. — 6 months
  Percentage of time for which heart rate (HR) is displayed.
• Feasibility of using a wireless monitoring system immediately after delivery for RR. — 6 months
  Percentage of time for which respiratory rate (RR) is displayed.
• Feasibility of using a wireless monitoring system immediately after delivery for SpO2. — 6 months
  Percentage of time for which blood oxygen saturation (SpO2) is displayed.
• Feasibility of using a wireless monitoring system immediately after delivery for Tskin — 6 months
  Percentage of time for which skin temperature (Tskin) is displayed.
• Feasibility of using a wireless monitoring system immediately after delivery - Gap occurence — 6 months
  Occurrence of gaps in signal detection/recordings (% and length in seconds).
• Feasibility of using a wireless monitoring system immediately after delivery - Gap causes — 6 months
  Causes of the gaps in signal detection/recordings.
• Feasibility of using a wireless monitoring system immediately after delivery - User satisfaction — 6 months
  Descriptive analysis of user surveys and their satisfaction with the wireless system.
• Safety of using a wireless system immediately after delivery - skin score — 6 months
  Skin score (Neonatal Skin Condition Score) to be determined by a blinded dermatologist using de-identified pictures of the skin after removal of the sensors of each system. A "perfect" score using the NSCS is 3; the worst score is 9.
• Safety of using a wireless system immediately after delivery - pain scale — 6 months
  Pain scale (Neonatal Infant Pain Scale) to assess any discomfort or pain during the removal of the sensors, with higher scores indicating greater pain.
• Safety of using a wireless system immediately after delivery - clinical event discrepancies — 6 months
  Clinically significant events detected by the wired system (HR \< 100 bpm or SpO2 \< 80%) but missed by the wireless system.
• Assess the accuracy of this wireless system - correlation coefficient. — 6 months
  Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Correlation coefficient
• Assess the accuracy of this wireless system - slope — 6 months
  Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Slop
• Assess the accuracy of this wireless system - variance accounted for — 6 months
  Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Variance accounted for
• Assess the accuracy of this wireless system - bias. — 6 months
  Measuring HR, RR, SpO2 and Tskin signals compared with the "standard of care" wired system - Bias

Trial sites (5)

Other trials for the same condition