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Advanced Wireless Sensors for Neonatal Care in the Delivery Room

RECRUITINGN/ASponsored by Guilherme Sant'Anna, MD
Actively Recruiting
PhaseN/A
SponsorGuilherme Sant'Anna, MD
Started2025-04-08
Est. completion2026-07-30
Eligibility
Age35 Weeks – 42 Weeks
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06693817

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

Age: 35 Weeks – 42 WeeksHealthy volunteers accepted
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

Conditions18

Apnea of NewbornBirth AsphyxiaBirth Outcome, AdverseDelivery ComplicationDelivery Problem for FetusECG Electrode Site ReactionHeart DiseaseInfant ALLInfant ApneaInfant Conditions

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