Amnioinfusion for Fetal Renal Failure

NCT06728228 | Recruiting DMC

• 1 other identifier: 2063654
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Fetal Renal Failure; Kidney Disease; MCDK; PCKD

Outcome Measures

Primary Outcomes (3)

• Fetal Survival to Dialysis

  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

  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]

  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 Outcomes (5)

• Number of infusions prior to rupture of membranes among participants in the intervention group

  During the pregnancy, up to 9 months

• Mean gestational age at rupture of membranes in the intervention group

  During the pregnancy, up to 9 months

• Mean gestational age at delivery in the intervention group

  During the pregnancy, up to 9 months

• Rate of fetal demise in utero among participants in the non-intervention group

  During the pregnancy, up to 9 months

• Mean gestational age at delivery in the non-intervention group

  During the pregnancy, up to 9 months

Study Arms (2)

Amnioinfusion

EXPERIMENTAL

Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.

Other: Amnioinfusion

Comfort Care/Expectant Management

NO INTERVENTION

The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.

Interventions

Amnioinfusion OTHER

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.

Also known as: Amniotic fluid injection

Amnioinfusion

Eligibility Criteria

• Gender Eligibility Details: This study only accepts pregnant women.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cervix less than 2.5 cm in length.
• 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).
• Other significant congenital anomalies in the fetus.
• Evidence of chorioamnionitis or abruptio placentae.
• Evidence of rupture of membranes or chorionic-amniotic separation.
• Evidence of preterm labor.
• Multiple gestation.
• Severe maternal medical condition in pregnancy.
• Clinically diagnosed maternal depression, psychoses, or anxiety that are refractory to treatment.
• Technical limitations precluding amnioinfusion.

Sponsors & Collaborators

• Fetal Care Center, PLLC: lead
• Medical City Children's Hospital: collaborator
• Medical City Women's Hospital: collaborator

Study Sites (1)

Fetal Care Center

Dallas, Texas, 75230, United States

RECRUITING

Related Publications (2)

• Miller JL, Baschat AA, Rosner M, Blumenfeld YJ, Moldenhauer JS, Johnson A, Schenone MH, Zaretsky MV, Chmait RH, Gonzalez JM, Miller RS, Moon-Grady AJ, Bendel-Stenzel E, Keiser AM, Avadhani R, Jelin AC, Davis JM, Warren DS, Hanley DF, Watkins JA, Samuels J, Sugarman J, Atkinson MA. Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial. JAMA. 2023 Dec 5;330(21):2096-2105. doi: 10.1001/jama.2023.21153.

  PMID: 38051327 BACKGROUND

• O'Hare EM, Jelin AC, Miller JL, Ruano R, Atkinson MA, Baschat AA, Jelin EB. Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial. Fetal Diagn Ther. 2019;45(6):365-372. doi: 10.1159/000497472. Epub 2019 Mar 21.

  PMID: 30897573 BACKGROUND

Related Links

• Renal Anhydramnios Fetal Therapy (RAFT) Trial Wesbite
• Fetal Care Center - Amnioinfusion FAQ

MeSH Terms

Conditions

Multicystic Dysplastic Kidney; Polycystic Kidney Diseases; Hereditary renal agenesis; Multicystic renal dysplasia, bilateral; Kidney Diseases

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases, Cystic; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Abnormalities, Multiple; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

Kevin P Magee, M.D.

CONTACT

(972) 566-5600; kevin.magee@fetalcaredallas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 5, 2024
• Primary Completion: November 15, 2025
• Study Completion (Estimated): November 15, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

US (1)