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New sensor could spare sick newborns from painful blood tests

NCT ID NCT04603547

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a sticker-like sensor on the skin can accurately measure carbon dioxide levels in newborns with brain injury who are receiving cooling treatment. About 53 babies will take part. If it works, it could replace frequent blood draws and make monitoring easier and less painful.

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.

Participants

53 people

The number who actually took part.

Started

Sep 2019

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.

Who is studied

Neonates with Neonatal Encephalopathy receiving therapeutic hypothermia

Ages

0 to 3 days

Sex

Anyone

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 Any neonates with neonatal encephalopathy admitted to receive therapeutic hypothermia will be a candidate for this study. Current criteria for therapeutic hypothermia at BWH include the following: 1. ≥34 weeks' gestation \+ 2. Any one of the followings 1. Sentinel event prior to delivery 2. Apgar score ≤ 5 at 10 min 3. Requires PPV, Intubation or CPR at 10 min 4. pH ≤ 7.1 (from cord or blood gas within 60 min of birth) e. Abnormal Base Excess ≤ - 10 mEq/L (from cord or blood gas within 60 min of birth) + 3. Any one of the followings: 1. Neonatal Encephalopathy Scale Exam Score ≥4 2. Seizure or clinical concern for seizure Exclusion criteria 1. Infants with major birth defect, genetic or metabolic syndrome 2. Neonates in extremis with possibility of redirection to palliative care

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia

As listed by the trial registrant

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

Neonatal encephalopathy

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.