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Amnioinfusion for Fetal Renal Failure

Not Applicable
Recruiting
Conditions
Multicystic Dysplastic Kidney
Polycystic Kidney Disease
Fetal Renal Anomaly
Anhydramnios
Potter Syndrome
Lung Hypoplasia
Multicystic Renal Dysplasia, Bilateral
Lower Urinary Tract Obstructive Syndrome
Bilateral Renal Agenesis
Registration Number
NCT06728228
Lead Sponsor
Fetal Care Center, PLLC
Brief Summary

The goal of this clinical trial is to learn if serial amnioinfusions can improve the chances of survival for fetuses with severe kidney problems that cause low amniotic fluid (anhydramnios). Low amniotic fluid can affect lung development and may lead to serious health issues for the fetus. The main questions this study aims to answer are:

* Can serial amnioinfusion increase the chances of survival for these fetuses?

* Does this procedure improve chances of survival until dialysis and/or kidney transplant?

Participants will:

* Receive regular amnioinfusions, which is a procedure that adds fluid to the amniotic cavity.

* Undergo monitoring to check the effects on the fetus and mother.

This study will help researchers understand if amnioinfusion is a useful treatment for fetal kidney problems and may provide valuable information for similar cases in the future.

Detailed Description

Fetal renal failure (FRF) is a severe and life-threatening condition caused by congenital abnormalities or inherited kidney diseases. In the womb, when the kidneys fail to function properly, this leads to a condition called anhydramnios-a complete lack of amniotic fluid. Amniotic fluid is essential for the fetus's lung development, particularly during the canalicular phase of pulmonary development, which occurs between 16 and 28 weeks of gestation. Without sufficient amniotic fluid, the lungs cannot develop properly, resulting in a condition known as pulmonary hypoplasia. Severe hypoplasia has previously been described as almost always fatal, typically leading to neonatal death shortly after birth.

In recent years, promising advances in fetal therapies have opened new doors for treating conditions that were once considered untreatable. One such intervention involves serial amnioinfusion, a procedure where sterile saline or another isotonic fluid is injected into the amniotic sac to restore fluid levels. Early studies, including the RAFT trial (Renal Anhydramnios Fetal Therapy), have demonstrated that this approach may improve survival rates by promoting lung development in fetuses with FRF. Building upon these findings, this study seeks to further evaluate the safety and effectiveness of serial amnioinfusion in improving neonatal outcomes for families facing this diagnosis.

This study will enroll approximately 60 pregnant individuals carrying singleton pregnancies complicated by FRF and anhydramnios. Participants will be divided into two groups: an intervention group, which will receive serial amnioinfusion procedures as deemed appropriate by the study doctor, and a control group, which will not undergo interventions and will receive comfort care for their pregnancies. The primary goals of the study are to evaluate maternal safety, assess fetal survival to dialysis, and determine survival to kidney transplant eligibility.

The amnioinfusion procedures will be performed at the Fetal Care Center by a team of experts in fetal procedures. To ensure patient safety, the study includes a rigorous monitoring plan to track any potential adverse events in real time. Data from imaging studies (e.g., ultrasound, echocardiogram, MRI) and laboratory biomarkers will be collected to evaluate fetal and maternal responses to the treatment. While the study focuses on improving outcomes for individual patients, it also has broader implications for science and society. By systematically analyzing the benefits and risks of serial amnioinfusion, this research could help refine treatment protocols and set the stage for new standards of care for FRF. For the families involved, participation in this study offers the possibility of improved survival for their children, with potential eligibility for life-saving kidney transplants in the future.

This study represents a critical step toward addressing a condition that has long been considered untreatable. Through collaboration, innovation, and rigorous research, the team aims to provide hope for families affected by FRF.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Fetal Survival to DialysisBirth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.

Proportion of neonates surviving to \>= 14 days and placement of dialysis access after serial amnioinfusions (defined as use of a dialysis catheter for \>=14 continuous days)

Fetal Survival to Transplant>=2 years after delivery.

The proportion of neonates who survive to receive a kidney transplant following continuous, successful dialysis.

Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]From enrollment in the study through delivery and up to 30 days postpartum.

Maternal safety will be assessed by tracking adverse events, including bleeding, infections, and preterm rupture of membranes, at each visit, after procedures, and postpartum. These events will be documented at each prenatal visit, following every amnioinfusion, at delivery, and during a follow-up period of at least 30 days postpartum. The safety evaluation will focus on identifying procedure-related complications and ensuring the well-being of participants throughout the study.

Secondary Outcome Measures
NameTimeMethod
Number of infusions prior to rupture of membranes among participants in the intervention groupDuring the pregnancy, up to 9 months

The practicality of performing serial amnioinfusions for early pregnancy renal anhydramnios will be evaluated by counting the number of infusions administered before rupture of membranes in the intervention group.

Mean gestational age at rupture of membranes in the intervention groupDuring the pregnancy, up to 9 months

The feasibility of serial amnioinfusions will be assessed by determining the average gestational age at which rupture of membranes occurs in the intervention group.

Mean gestational age at delivery in the intervention groupDuring the pregnancy, up to 9 months

The feasibility of serial amnioinfusions will be measured by calculating the mean gestational age at delivery among participants in the intervention group.

Rate of fetal demise in utero among participants in the non-intervention groupDuring the pregnancy, up to 9 months

An exploratory analysis will examine the natural progression of untreated early pregnancy renal anhydramnios by analyzing the rate of in utero fetal demise in the non-intervention group.

Mean gestational age at delivery in the non-intervention groupDuring the pregnancy, up to 9 months

An exploratory study will investigate the natural history of untreated early pregnancy renal anhydramnios by calculating the average gestational age at delivery for participants in the non-intervention group.

Trial Locations

Locations (1)

Fetal Care Center

🇺🇸

Dallas, Texas, United States

Fetal Care Center
🇺🇸Dallas, Texas, United States
Kevin P Magee, M.D.
Contact
(972) 566-5600
kevin.magee@fetalcaredallas.com

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