← Back to Clinical Trials
Recruiting NCT06693817

Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Trial Parameters

Condition Sudden Unexplained Infant Death
Sponsor Guilherme Sant'Anna, MD
Study Type INTERVENTIONAL
Phase N/A
Enrollment 600
Sex ALL
Min Age 35 Weeks
Max Age 42 Weeks
Start Date 2025-04-08
Completion 2026-07-30
Interventions
Wireless skin sensors vital sign monitoring systemWired vital sign monitoring system

Brief 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 Criteria

Inclusion criteria: 1. Newborns ≥35 weeks (gestational age) 2. Newborns determined to be clinically stable at delivery 3. Newborns with no skin abnormalities Exclusion criteria: 1. Newborns ≤ 35 weeks (gestational age) 2. Newborns determined to not be clinically stable at delivery 3. Newborns with Skin abnormalities

Related Trials