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Advanced Wireless Sensors for Neonatal Care in the Delivery Room

ConditionsSudden Unexplained Infant DeathApnea of NewbornNewborn MorbidityNewborn AsphyxiaBirth Outcome, AdverseBirth AsphyxiaPregnancy RelatedNewborn; VitalityECG Electrode Site ReactionInfant ALLInfant DeathInfant, Newborn, DiseasesInfant ApneaInfant ConditionsParentsDelivery Problem for FetusDelivery Complication
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-42
SponsorGuilherme Sant'Anna, MD

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Newborns ≥35 weeks (gestational age)

Newborns determined to be clinically stable at delivery

Newborns with no skin abnormalities

Disqualifiers

Newborns ≤ 35 weeks (gestational age)

Newborns determined to not be clinically stable at delivery

Newborns with Skin abnormalities

Trial design

Design model

Crossover

Treatments tested in this trial

  • Wireless skin sensors vital sign monitoring system

    Device

    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

    Device

    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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Vaginal BirthOther 2 interventions
Group B: C-Section BirthOther 2 interventions

Trial outcomes

Primary outcomes

1

Feasibility of using a wireless monitoring system immediately after delivery for HR.

Percentage of time for which heart rate (HR) is displayed.

Time frame
6 months
2

Feasibility of using a wireless monitoring system immediately after delivery for RR.

Percentage of time for which respiratory rate (RR) is displayed.

Time frame
6 months
3

Feasibility of using a wireless monitoring system immediately after delivery for SpO2.

Percentage of time for which blood oxygen saturation (SpO2) is displayed.

Time frame
6 months
4

Feasibility of using a wireless monitoring system immediately after delivery for Tskin

Percentage of time for which skin temperature (Tskin) is displayed.

Time frame
6 months

Secondary outcomes

1

Time between sensors placement and data display (seconds)

To determine the time (seconds)between sensors placement and data display for each system (seconds)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guilherme Sant'Anna, MD

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor institution

Hospital Universitário da Universidade Estadual de Londrina

Collaborator

Nuovo Ospedale degli Infermi

Collaborator

Luzerner Kantonsspital

Collaborator

Source ClinicalTrials.gov
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