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Could wireless sensors replace wires for newborn monitoring?

NCT ID NCT06693817

Knowledge-focused Sponsor: Guilherme Sant'Anna, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a new wireless skin sensor system can safely and accurately monitor the heart rate, breathing, oxygen levels, and temperature of healthy newborns right after birth. 600 babies will wear both the wireless sensors and standard wired monitors for the first two hours of life. The goal is to see if the wireless system works as well as the wired one, with less skin irritation and more freedom for parents to hold their baby.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a safer, less intrusive way to monitor newborns in the delivery room, potentially reducing skin damage and allowing parents to hold their baby more easily.
What could go wrong
This is an early feasibility study, not a treatment trial. The wireless system may prove less accurate or reliable than wired monitors, and results may not apply to sick or premature babies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 42 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia apnea of prematurity childhood acute lymphoblastic leukemia Infant Death Infant, Newborn, Diseases infantile apnea perinatal asphyxia perinatal disease pregnancy disorder sudden unexpected infant death

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Apnea of newborn Birth asphyxia Birth outcome, adverse Delivery complication Delivery problem for fetus Ecg electrode site reaction Infant ALL Infant apnea Infant conditions Infant death Infant, newborn, diseases Newborn asphyxia Newborn morbidity Newborn; vitality Parents Pregnancy related Sudden unexplained infant death

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitário da Universidade Estadual de Londrina

    NOT_YET_RECRUITING

    Londrina, Paraná, 86038-350, Brazil

  • Lucerne Cantonal Hospital

    NOT_YET_RECRUITING

    Lucerne, Canton of Lucerne, Switzerland

  • Montreal Children's Hospital

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Nuovo Ospedale degli Infermi

    NOT_YET_RECRUITING

    Ponderano, BI, 13875, Italy

  • Royal Victoria Hospital

    RECRUITING

    Montreal, Quebec, Canada

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