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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mauro Schenone, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Adverse EventsFirst amnioinfusion through delivery which may be up to 22 weeks.
Total number of Adverse Events experienced