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Can a simple color check speed up newborn breathing support?

NCT ID NCT06258187

Knowledge-focused Sponsor: University of Texas Southwestern Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 using a Pedi-Cap, a device that changes color to show carbon dioxide levels, can shorten the time newborns need breathing help in the delivery room. About 632 infants born at 30 weeks or later who need face mask ventilation will be included. The research team will compare months when the device is used versus months when it is not, and also survey staff about their experience.

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 632 people

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

Started

Mar 2024

Expected to finish

Mar 2026

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

30 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Infants born at ≥30 weeks' gestation * Presence of the resuscitation team prior to delivery * Need for non-invasive positive pressure ventilation (PPV). Exclusion Criteria: * Infants born at \<30 weeks' gestation * No non-invasive PPV needed in the delivery room * Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia * Resuscitation team not present prior to delivery/need for PPV * Infants who have a prenatal plan of comfort care only

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Conditions

The condition(s) this trial relates to.

Infant, Newborn, Diseases

As listed by the trial registrant

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

Neonatal disease Neonatal resuscitation

Contacts and locations

Locations

  • Parkland Health

    Dallas, Texas, 75235, United States

More trials for these conditions

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