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Device

Wireless Sensors for Neonatal Care (AWARD Trial)

N/A

Waitlist Available

Led By Guilherme Sant'Anna, MD, PhD

Research Sponsored by Guilherme Sant'Anna, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborns with no skin abnormalities

Newborns ≥35 weeks (gestational age)

Must not have

Newborns ≤ 35 weeks (gestational age)

Newborns determined to not be clinically stable at delivery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a new wireless vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants. The study will assess the feasibility, safety, and accuracy of the wireless system compared

Who is the study for?

This trial is for healthy newborns born at or after 35 weeks of pregnancy. It aims to see if a new wireless sensor system can track their vital signs right after birth and during the first two hours under unsupervised parental care.

What is being tested?

The study compares an advanced wireless skin sensor system with the traditional wired system for monitoring vital signs in newborns. Researchers will check how feasible, safe, and accurate the wireless system is immediately after delivery.

What are the potential side effects?

Since this is an observational study focusing on monitoring equipment rather than medication or invasive procedures, significant side effects are not anticipated. However, there may be minimal risks associated with wearing the sensors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My newborn has normal skin.

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My newborn is at least 35 weeks old in gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby was born at or before 35 weeks of pregnancy.

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My newborn was not stable after birth.

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My newborn has skin abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the accuracy of this wireless system - bias.

Assess the accuracy of this wireless system - correlation coefficient.

Assess the accuracy of this wireless system - slope

+11 more

Secondary study objectives

Time between sensors placement and data display (seconds)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Vaginal BirthExperimental Treatment2 Interventions

Wireless monitoring system placed first for vaginal birth. 15-20 minutes later, the wired monitoring system is placed. Both systems stay in place for 2 hours.

Group II: C-Section BirthExperimental Treatment2 Interventions

System placement randomized for C-section. One system placed first and the alternate placed immediately after. Both systems stay in place for 2 hours.

0 / 5Eligibility criteria met