Miniaturized Vital Sign Monitoring for Newborns in the Delivery Room
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wireless MicroPremVitals Button Sensor.
- Who it may be relevant to
- Registry conditions: Vital Signs Monitoring, Newborn Monitoring, Physiologic Monitoring. Basic parameters: up to 24 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This prospective observational study aims to evaluate the accuracy, safety, and feasibility of the Wireless MicroPremVitals Button Sensor System for continuous monitoring of electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature in newborn infants in the delivery room. Measurements obtained from the wireless sensor system will be compared with standard-of-care monitoring. The study will also assess skin tolerability, signal quality, and parent and healthcare provider perceptions of the device.
Interventions
- Device Wireless MicroPremVitals Button Sensor
A wireless wearable sensor system applied to newborn infants in the delivery room to continuously measure electrocardiography (ECG), heart rate, respiratory rate, oxygen saturation, and skin temperature. Measurements will be compared with standard-of-care monitoring for validation purposes only and will not be used for clinical decision-making.
Primary outcome measures
- Electrocardiography (ECG) Accuracy [Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth]
- Skin Temperature Accuracy [Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.]
- Oxygen Saturation (SpO₂) Accuracy [Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.]
Secondary outcome measures (2)
- Heart Rate Accuracy [Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.]
- Heart Rate Variability (HRV) [Time frame: During two 15-minute monitoring periods within the first 90 minutes after birth.]
Eligibility criteria
Inclusion criteria
\- Infants born by C-Section or vaginal delivery, with ≥35 weeks of gestational age and judged clinically stable immediately after birth.
Exclusion criteria
- Infants with skin abnormality would potentially increase the risk of injury.
- Family experiencing too much stress as determined by an attending physician or bedside care team, to not be approached for recruitment.
- Infants born at <35 weeks gestational age.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07739810 · Button Sensors in the DR