Actively Recruiting
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies - a Feasibility Study
Led by Mayo Clinic · Updated on 2025-11-12
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating serial amnioinfusions as a potential treatment for fetuses with severe lower urinary tract obstruction (LUTO) and bilateral renal agenesis, conditions that cause severe lung underdevelopment and high mortality. These congenital anomalies result in a lack of amniotic fluid, which is critical for lung growth, leading to a high risk of death or serious kidney problems after birth. This Phase 1 study aims to reduce lung issues to improve newborn survival chances and allow for treatments like dialysis. The study involves weekly ultrasound-guided amnioinfusions using warm lactated Ringer's solution to restore amniotic fluid levels until about 34 weeks of pregnancy, or until a complication like premature rupture of membranes occurs. Before each infusion, a small amount of amniotic fluid is collected for research. This treatment is offered to pregnant women carrying affected fetuses diagnosed between 18 and 25 weeks gestation. Standard prenatal care continues alongside the study procedures. Participants will have weekly ultrasound monitoring and hospital stays of about two days after each infusion if no contractions occur. After birth, infants will be followed for two years with care from specialists in neonatology, nephrology, and transplantation. Their development will be assessed using clinical exams and the Bayley Scale of Infant Development. The study will measure safety by tracking adverse events from the first infusion through delivery, and will also monitor survival to dialysis and kidney transplant.
CONDITIONS
Brief Title
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a single fetus
- Maternal age over 18 years
- Fetus less than 26 weeks gestation with severe lower urinary tract obstruction and intrauterine renal failure
- Fetus less than 26 weeks gestation with bilateral renal agenesis
- Fetus without chromosome abnormalities
- Fetus without other associated anomalies
- Mother with negative tests for Hepatitis B, Hepatitis C, and HIV
- Mother meets psychosocial criteria to make informed decisions about fetus/infant
You will not qualify if you...
- Fetus with anomalies unrelated to lower urinary tract obstruction or renal agenesis
- Increased risk for preterm labor such as short cervix, history of incompetent cervix, or previous preterm birth
- Known placental abnormalities at enrollment
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
- Maternal medical conditions contraindicating surgery or anesthesia
- Mother declined invasive testing
- Inability to comply with travel and follow-up
- Participation in other interventional studies affecting maternal or fetal health
- Participation in this clinical trial during a previous pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From diagnosis between 18 to 25 6/7 weeks until 34 weeks gestation or earlier if membranes rupture
Participants receive weekly ultrasound-guided amnioinfusions where warm sterile lactated Ringers solution is injected into the amniotic cavity to restore amniotic fluid levels until the fetus reaches 34 weeks or if preterm premature rupture of membranes occurs.
Weekly visits for amnioinfusion procedures with approximately 2 days hospital stay after each infusion
Duration - Up to 24 months after birth
Participants undergo monitoring and infants are followed postnatally for 24 months including neurodevelopmental assessments using clinical exams and the Bayley Scale of Infant Development.
Regular follow-up visits with neonatology, pediatric nephrology, and transplant teams
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
T
Taylor M Rasmusson, MSN
J
Jainnee McCann
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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