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New test using stomach fluid may predict breathing trouble in newborns

NCT ID NCT07344714

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether analyzing stomach fluid from newborns can predict if they will need breathing support for more than 6 hours after birth. Researchers will enroll 500 babies born at 32 weeks or later in a lower-level NICU. The goal is to see if a new algorithm can accurately identify which babies are at risk for respiratory distress syndrome and other breathing issues, helping doctors make faster decisions.

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 simple test that helps doctors predict breathing problems in newborns earlier, potentially improving care in lower-level NICUs.
What could go wrong
This is an early observational study, not a treatment trial. The prediction method may not be accurate enough for widespread use, and results may not apply to all newborns.

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

About 500 people

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

Started

Mar 2026

Expected to finish

Dec 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.

Who is studied

Neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.

Ages

32 to 41 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: Both of the following: * Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated * Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization. Exclusion Criteria: Any one of the following: * Neonates with known or suspected congenital anomalies * Neonates for whom only comfort measures are planned or possible at time of delivery * Neonates whose parents actively declined the Minnesota Research Authorization. * Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.

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Conditions

The condition(s) this trial relates to.

Hyaline Membrane Disease meconium aspiration syndrome neonatal respiratory failure newborn respiratory distress syndrome pneumothorax respiratory distress syndrome in premature infants Respiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn

As listed by the trial registrant

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

Hyaline membrane disease Meconium aspiration syndrome Pneumonia neonatal Pneumothorax Respiratory distress neonatal Respiratory distress syndrome in premature infant Respiratory distress syndrome, newborn Transient tachypnea of the newborn

How to take part

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  1. The places running it

    1 site. 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

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

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