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Can a warm fluid wash away newborn breathing risks? PEARL trial aims to find out

NCT ID NCT07274527

Disease control Sponsor: Medical College of Wisconsin 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

Thick meconium in the amniotic fluid affects about 1 in 7 pregnancies and can cause breathing problems in newborns. The PEARL trial tests whether infusing warm sterile fluid into the uterus during labor reduces these risks. The study will enroll 320 pregnant people at 36 weeks or later, randomly assigning them to receive the infusion or standard care. Researchers will also check cord blood for inflammation and follow up at 12 months to see if children develop normally.

What this could mean

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

Active substance
warm lactated ringer's solution infused into the uterus
What this could lead to
If it works, this could provide a simple, standardized way to reduce breathing problems in newborns exposed to thick meconium during labor.
What could go wrong
This is a single trial with 320 participants, and earlier studies on amnioinfusion had mixed results. The benefits may be small or not apply to all hospitals.

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 320 people

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

Started

May 2026

Expected to finish

Apr 2030

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

18 years 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: * Maternal age greater than or equal to 18 years old * Singleton pregnancy * Gestational age of greater than or equal to 36 weeks 0 days gestation * Cephalic presentation * Cercial dilation between 2-10 centimeters * Meconium Exclusion Criteria: * Major fetal anomaly * Multiple gestation * Eunice Kennedy Shrive National Institute of Child Health and Human Developmet (NICHD) Category III fetal heart tracing * Contraindication to internal monitors * Prelabor premature ruptuore of membranes before 36 weeks 0 days gestation, - Inability to consent

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Conditions

The condition(s) this trial relates to.

acidosis disorder perinatal asphyxia Perinatal Death perinatal disease pregnancy disorder with abortive outcome

As listed by the trial registrant

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

Amnioinfusion Cord blood CPAP Maternal morbidity Mechanical ventilation Meconium Neonatal acidosis Neonatal brain injury Neonatal respiratory distress related conditions Nicu admission Perinatal death Perinatal morbidity Surfactant

How to take part

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

  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

  • Froedtert Hospital and Medical College of Wisconsin Birth Center

    RECRUITING

    Milwaukee, Wisconsin, 53045, United States

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