Amnioinfusion for Fetal Renal Failure

December 18, 2024 updated by: Fetal Care Center, PLLC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Confirmed anhydramnios before 22 weeks GA for patients with FRF.
  2. Consent is signed and first therapeutic amnioinfusion can and does occur before 28 weeks and 6/7 days GA.
  3. Confirmation that the expectant mother understands her options for management of the pregnancy.
  4. Age ≥18 years of age.
  5. Willingness to be followed by the Fetal Care Center at Dallas and deliver at Medical City Dallas.
  6. Willingness for postnatal care to be performed at Medical City Dallas Hospital/the Fetal Care Center until maternal discharge.
  7. Consults with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric surgery, Maternal-Fetal Medicine Specialist, and a Genetic Counselor.

Exclusion criteria:

  1. Cervix less than 2.5 cm in length.
  2. No fatal findings on Karyotype (e.g trisomy 13, or 18) or Microarray fatal findings excluding those that are related to pulmonary hypoplasia due to fetal renal failure (e.g. Meckel-Gruber, PCKD).
  3. Other significant congenital anomalies in the fetus.
  4. Evidence of chorioamnionitis or abruptio placentae.
  5. Evidence of rupture of membranes or chorionic-amniotic separation.
  6. Evidence of preterm labor.
  7. Multiple gestation.
  8. Severe maternal medical condition in pregnancy.
  9. Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
  10. Technical limitations precluding amnioinfusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amnioinfusion
Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.
Other: Amnioinfusion
A 20- or 22-gauge spinal needle (routinely used obstetrics and gynecology needle) will be used by an expert in fetal procedures with sterile technique to access the amniotic cavity under real-time ultrasound guidance to infuse isotonic fluid (Lactated Ringers with 1g/L of Oxacillin). This fluid will act as replacement amniotic fluid. Regular monitoring of fluid levels may suggest serial infusion, which will be completed as deemed necessary by the study doctor.
Other Names:
  • Amniotic fluid injection
No Intervention: Comfort Care/Expectant Management
The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal Survival to Dialysis
Time Frame: Birth 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)
Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks.
Fetal Survival to Transplant
Time Frame: >=2 years after delivery.
The proportion of neonates who survive to receive a kidney transplant following continuous, successful dialysis.
>=2 years after delivery.
Incidence of Maternal Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 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.
From enrollment in the study through delivery and up to 30 days postpartum.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of infusions prior to rupture of membranes among participants in the intervention group
Time Frame: During 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.
During the pregnancy, up to 9 months
Mean gestational age at rupture of membranes in the intervention group
Time Frame: During 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.
During the pregnancy, up to 9 months
Mean gestational age at delivery in the intervention group
Time Frame: During 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.
During the pregnancy, up to 9 months
Rate of fetal demise in utero among participants in the non-intervention group
Time Frame: During 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.
During the pregnancy, up to 9 months
Mean gestational age at delivery in the non-intervention group
Time Frame: During 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.
During the pregnancy, up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fetal Care Center, PLLC

Collaborators

Medical City Children's Hospital
Medical City Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 6, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2063654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anhydramnios

  • Johns Hopkins University
    Eunice Kennedy Shriver National Institute of Child Health and Human Development...
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    Renal Anhydramnios Fetal Therapy (RAFT)
    Anhydramnios | Potter Syndrome | Lung Hypoplasia | Multicystic Dysplastic Kidney | Multicystic Renal Dysplasia, Bilateral | Lower Urinary Tract Obstructive Syndrome | Fetal Renal Anomaly
    United States

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