Actively Recruiting

Phase Not Applicable
FEMALE
ID06728228

Amnioinfusion for Fetal Renal Failure Evaluating Serial Amnioinfusions to Improve Survival in Fetuses with Severe Kidney Problems

Led by Fetal Care Center, PLLC · Updated on 2024-12-20

35

Participants Needed

1

Research Sites

101 weeks

Total Duration

On this page

Sponsors

F

Fetal Care Center, PLLC

Lead Sponsor

M

Medical City Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether serial amnioinfusion can improve survival for fetuses with severe kidney failure that causes a lack of amniotic fluid, a condition called anhydramnios. This lack of fluid can prevent proper lung development, leading to serious health problems and often neonatal death. The study focuses on determining if adding fluid through amnioinfusion can increase chances of survival until the fetus can receive dialysis or a kidney transplant. This trial builds on earlier research suggesting potential benefits of this treatment for fetal renal failure (FRF). Pregnant individuals with singleton pregnancies affected by FRF and anhydramnios will be enrolled and split into two groups: one receiving serial amnioinfusions using a spinal needle to inject sterile isotonic fluid into the amniotic sac under ultrasound guidance, and a control group receiving comfort care without intervention. The amnioinfusions are performed by fetal procedure experts as needed, based on regular monitoring. The study includes a thorough monitoring plan to ensure maternal safety and track fetal and maternal responses through imaging and lab tests. Participants will be closely followed by a specialized fetal care team and deliver at a designated hospital. Assessments include fetal survival to dialysis and transplant eligibility, as well as monitoring maternal treatment-related side effects from enrollment through delivery and up to 30 days postpartum. Data collected will help evaluate the safety and effectiveness of serial amnioinfusion and may guide future treatments for fetal kidney failure conditions.

CONDITIONS

Official Title

Amnioinfusion for Fetal Renal Failure

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed anhydramnios before 22 weeks of gestation for fetal renal failure
  • Signed consent and first amnioinfusion before 28 weeks and 6 days of gestation
  • Expectant mother understands pregnancy management options
  • 18 years of age or older
  • Willing to be followed and deliver at the Fetal Care Center at Dallas and Medical City Dallas
  • Agree to postnatal care at Medical City Dallas Hospital/Fetal Care Center until discharge
  • Consultations with pediatric nephrology, neonatology, transplant surgery, pediatric surgery, maternal-fetal medicine, and genetic counseling
Not Eligible

You will not qualify if you...

  • Cervix shorter than 2.5 cm
  • Fatal genetic findings unrelated to pulmonary hypoplasia due to fetal renal failure
  • Other significant fetal congenital anomalies
  • Signs of infection (chorioamnionitis) or placental abruption
  • Ruptured membranes or separation between chorion and amnion
  • Signs of preterm labor
  • Multiple pregnancies
  • Severe maternal medical conditions during pregnancy
  • Untreated or treatment-resistant maternal depression, psychosis, or anxiety
  • Technical reasons preventing safe amnioinfusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fetal Care Center

Dallas, Texas, United States, 75230

Actively Recruiting

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Research Team

K

Kevin P Magee, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial.

Jena L Miller, Ahmet A Baschat, Mara Rosner...

https://pubmed.ncbi.nlm.nih.gov/38051327

Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial.

Elizabeth M O'Hare, Angie C Jelin, Jena L Miller...

https://pubmed.ncbi.nlm.nih.gov/30897573