Advanced Wireless Sensors for Neonatal Care in the Delivery Room
Recruiting now · Not applicable
Conditions studied: Sudden 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
In brief
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.
Key facts
- Study ID
- NCT06693817
- Run by
- Guilherme Sant'Anna, MD
- People needed
- 600
- Starts
- 2025-04-08
- Expected to finish
- 2027-12-30
- Last updated by the study team
- 2026-05-08
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Newborns ≥35 weeks (gestational age)
- Newborns determined to be clinically stable at delivery
- Newborns with no skin abnormalities
You may not qualify if…
- Newborns ≤ 35 weeks (gestational age)
- Newborns determined to not be clinically stable at delivery
- Newborns with Skin abnormalities
Where it is running
- Montreal Children's Hospital — Montreal, Quebec, Canada (enrolling)
- Royal Victoria Hospital — Montreal, Quebec, Canada (enrolling)
- Hospital Universitário da Universidade Estadual de Londrina — Londrina, Paraná, Brazil
- Nuovo Ospedale degli Infermi — Ponderano, BI, Italy
- Lucerne Cantonal Hospital — Lucerne, Canton of Lucerne, Switzerland
Full record on ClinicalTrials.gov
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