Advanced Wireless Sensors for Neonatal Care in the Delivery Room

ConditionsSudden Unexplained Infant Death Apnea of Newborn Newborn Morbidity Newborn Asphyxia Birth Outcome, Adverse Birth Asphyxia Pregnancy Related Newborn; Vitality ECG Electrode Site Reaction Infant ALL Infant Death Infant, Newborn, Diseases Infant Apnea Infant Conditions Parents Delivery Problem for Fetus Delivery 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

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

Treatments tested in this trial

Wireless skin sensors vital sign monitoring system
Wired vital sign monitoring system

Treatment groups

600 Participants

are divided into 2 treatment groups

Sponsors and collaborators

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