RecruitingPhase 1NCT03723564

Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies- a Feasibility Study


Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Oct 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%) requiring dialysis or renal transplantation if no fetal intervention is performed. Renal agenesis is the congenital absence of one or both kidneys due to complete failure of the kidney to form. As many as 33% of fetuses with bilateral renal agenesis are stillborn, and the rest of them die immediately after birth due to severe pulmonary hypoplasia. The objective of the serial amnioinfusions for fetuses with these conditions will be to reduce the severity of pulmonary hypoplasia (regenerating the lung functionality) and therefore increase the chance that the newborn survives to begin peritoneal dialysis. Although there is initial evidence that serial amnioinfusions are feasible for the pregnant women and the fetuses, there is still a need to have a prospective clinical trial to confirm the hypothesis that serial amnioinfusions could prevent severe pulmonary hypoplasia allowing the newborns with bilateral renal agenesis or severe LUTO to survive to begin peritoneal dialysis. Therefore, the investigators aim to study the hypothesis that serial amnioinfusions for fetuses with severe LUTO and renal failure and those with bilateral renal agenesis will reduce the severity of pulmonary hypoplasia and therefore increase the chance that the newborn survives to begin peritoneal dialysis.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests whether repeatedly infusing fluid into the amniotic sac (amnioinfusion) can help lungs develop in fetuses with severe urinary tract or kidney problems that cause very low amniotic fluid levels. Normally, amniotic fluid — partly made up of fetal urine — is essential for lung development. When the kidneys are severely abnormal or absent, there is too little fluid, and the lungs may not grow properly, which is often fatal. Pregnant women carrying fetuses with these severe conditions can choose to participate and undergo a series of amnioinfusions to replace the fluid. The goal is to create enough fluid to allow the lungs to develop so that the baby can survive after birth. This is a very experimental procedure for conditions that otherwise have very limited treatment options. You may be eligible if: - You are a pregnant adult (over 18) carrying a single fetus - Your fetus is under 26 weeks gestational age with severe lower urinary tract obstruction and kidney failure, OR bilateral kidney absence - Your fetus has no other unrelated abnormalities - You have tested negative for hepatitis B, C, and HIV You may NOT be eligible if: - You have risk factors for preterm labor (short cervix, incompetent cervix, prior preterm birth) - You have placental abnormalities - You have previously participated in this trial during a pregnancy - You have a medical condition that makes surgery or anesthesia unsafe - You are unable to meet the travel and follow-up requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLactated Ringers Solution for Injection

Using ultrasound guidance, a 22 gauge needle will be introduced into amniotic cavity. Warmed Lactated Ringers solution will be injected into the amniotic cavity until an AFI of 8.0 cm is achieved


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT03723564


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