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Womb fluid injections could give babies with no kidneys a chance to breathe

NCT ID NCT03723564

Disease control Sponsor: Mayo Clinic 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether repeatedly injecting a sterile saltwater solution into the womb can help fetuses with severe kidney problems grow their lungs. Normally, these babies have too little amniotic fluid, which prevents the lungs from developing. The goal is to see if this procedure is safe and can help enough babies survive to start dialysis or get a kidney transplant after birth. The study involves 40 pregnant women and their fetuses.

What this could mean

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

Active substance
Lactated Ringer's solution (a sterile saltwater-like fluid)
What this could lead to
If it works, this could allow babies born with severe kidney problems to survive long enough to start dialysis or receive a kidney transplant.
What could go wrong
This is a very early feasibility study with only 40 participants. The procedure may not improve lung growth enough, and there are risks of infection, preterm labor, or other complications for both mother and baby.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

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

Started

Oct 2018

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Pregnant women with singleton uterine pregnancy * Maternal age \> age 18 * Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure * Fetus \< 26 weeks gestational age with bilateral renal agenesis * Fetus with absence of chromosome abnormalities * Fetus with absence of associated anomalies * Mother has negative Hepatitis B, Hepatitis C, and HIV testing * Mother meets psychosocial criteria that allows her to make a conscious decision about her fetus/infant Exclusion Criteria: * Associated fetal anomaly unrelated to LUTO or renal agenesis * Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth * Placental abnormalities known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal medical condition that is a contraindication to surgery or anesthesia * Mother has declined invasive testing * Inability to comply with the travel and follow-up requirements of the trial * Participation in another interventional study that influences maternal and fetal morbidity and mortality * Participation in this clinical trial during a previous pregnancy

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Conditions

The condition(s) this trial relates to.

bilateral renal agenesis Congenital Abnormalities congenital anomaly of kidney and urinary tract Hereditary renal agenesis renal agenesis urinary tract obstruction

As listed by the trial registrant

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

Congenital renal anomaly nos Lower urinary tract obstructive syndrome Renal agenesis and dysgenesis Renal failure congenital

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

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

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