Actively Recruiting

Phase Not Applicable
Age: 35Weeks - 42Weeks
All Genders
Healthy Volunteers
NCT06693817

Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Led by Guilherme Sant'Anna, MD · Updated on 2026-05-08

600

Participants Needed

5

Research Sites

142 weeks

Total Duration

On this page

Sponsors

G

Guilherme Sant'Anna, MD

Lead Sponsor

H

Hospital Universitário da Universidade Estadual de Londrina

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Advanced Wireless Sensors for Neonatal Care in the Delivery Room

Who Can Participate

Age: 35Weeks - 42Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns at or above 35 weeks gestational age
  • Newborns determined to be clinically stable at delivery
  • Newborns with no skin abnormalities
Not Eligible

You will not qualify if you...

  • Newborns below or equal to 35 weeks gestational age
  • Newborns determined to not be clinically stable at delivery
  • Newborns with skin abnormalities

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Hospital Universitário da Universidade Estadual de Londrina

Londrina, Paraná, Brazil, 86038-350

Not Yet Recruiting

2

Montreal Children's Hospital

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

3

Royal Victoria Hospital

Montreal, Quebec, Canada

Actively Recruiting

4

Nuovo Ospedale degli Infermi

Ponderano, BI, Italy, 13875

Not Yet Recruiting

5

Lucerne Cantonal Hospital

Lucerne, Canton of Lucerne, Switzerland

Not Yet Recruiting

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Research Team

G

Guilherme Sant´Anna, MD, PhD

CONTACT

A

Alyssa Maximov, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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