Experimental fetal fluid therapy aims to save babies born without kidneys
NCT ID NCT03101891
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This trial tests whether repeatedly adding sterile fluid into the womb can help fetuses with severe kidney failure grow enough lungs to survive after birth. Pregnant women with early pregnancy kidney failure can choose to receive the infusions or just be monitored. Babies who survive will need intensive care, dialysis, and eventually a kidney transplant. The study is no longer enrolling for one type of kidney problem but continues for others.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- serial amnioinfusions with isotonic fluid
- What this could lead to
- If it works, this could help babies with severe kidney failure survive birth by improving lung growth, though they will still need lifelong dialysis and a kidney transplant.
- What could go wrong
- This is an early phase 1 trial with only 70 participants and no random assignment. There is a high risk of early rupture of membranes and premature delivery. The treatment does not fix the kidneys.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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55 people
The number who actually took part.
- Started
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Dec 2018
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed anhydramnios before 22 weeks gestational age (GA) for patients with fetal renal failure (excluding bilateral renal agenesis) 2. Consent is signed and first therapeutic amnioinfusion can and does occur before 26 weeks and 0 days GA 3. Confirmation that the expectant mother does not wish to undergo termination of the pregnancy 4. Age ≥ 18 years of age for expectant mothers 5. Willingness to be followed and deliver at a RAFT center 6. Willingness for postnatal care to be performed at a RAFT center until discharge 7. Completed consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and Licensed Clinical Social Worker and a Genetic Counselor Exclusion Criteria: 1. Cervix less than 2.5 cm in length 2. No significant pathogenic or likely significant pathogenic findings on Karyotype or Microarray 3. Other significant congenital anomalies in the fetus 4. Evidence of chorioamnionitis or abruptio placentae 5. Evidence of rupture of membranes or chorioamniotic separation 6. Evidence of preterm labor 7. Multiple gestation 8. Severe maternal medical condition in pregnancy. 9. Maternal depression as assessed by a Beck Depression Inventory score equal to or greater than 17 that is refractory to treatment 10. Technical limitations precluding amnioinfusion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Columbia University
New York, New York, 10032, United States
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Mayo Clinic
Rochester, Minnesota, 55902, United States
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Stanford University
Stanford, California, 94305, United States
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University of California San Francisco
San Francisco, California, 94158, United States
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University of Colorado Denver
Aurora, Colorado, 80045, United States
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University of Southern California/Children's Hospital of Los Angeles/Huntington Hospital
Los Angeles, California, 90033, United States
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University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
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