Serial Amnioinfusions for Pulmonary Hypoplasia

This study is looking at a treatment for severe conditions in unborn babies called lower urinary tract obstruction (LUTO) and bilateral renal agenesis (when kidneys don't form). These conditions can lead to severe pulmonary hypoplasia (underdeveloped lungs) because there isn't enough amniotic fluid. Researchers are testing serial amnioinfusions, where warmed Lactated Ringers Solution for Injection is added to the amniotic fluid using a needle, to see if it can help. You might be able to join if you are pregnant with a single baby, over 18, and your baby is less than 26 weeks old with severe LUTO or bilateral renal agenesis, and no other genetic problems. The main goal is to track any side effects from the amnioinfusions. The study is currently recruiting, with a plan to enroll up to 40 participants.

Study design
This is an interventional study planning to enroll up to 40 participants. The study will initially review data after approximately 10 cases to decide on continuing.
What's involved
You would receive serial ultrasound-guided amnioinfusion procedures in an operating room at Mayo Clinic, Rochester, between 18 and 25 weeks of pregnancy.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured from the first amnioinfusion through delivery, which could be up to 22 weeks.

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NCT03723564

Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

Recruiting
PHASE1All AgesInterventionalTreatment
Mayo Clinic
~40 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:Lactated Ringers Solution for Injection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over First amnioinfusion through delivery which may be up to 22 weeks.
Renal Failure Congenital
Congenital Renal Anomaly Nos
Renal Agenesis and Dysgenesis
Lower Urinary Tract Obstructive Syndrome
1 sites across 1 states
Minnesota1
  • Mauro Schenone, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • Adverse EventsFirst amnioinfusion through delivery which may be up to 22 weeks.

    Total number of Adverse Events experienced