Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Recruiting
Phase 1
Interventional Study
Renal Failure Congenital
Congenital Renal Anomaly Nos
Renal Agenesis and Dysgenesis
Lower Urinary Tract Obstructive Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Mayo Clinic · Other
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About This Trial
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 transpl…
Trial Locations
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Eligibility Criteria
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
* Fet…
Contacts