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Amnioinfusion for Fetal Renal Failure

NCT06728228 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-12-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical City Children's Hospital

    collaborator OTHER

  • Medical City Women's Hospital

    collaborator UNKNOWN

  • Fetal Care Center, PLLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2025-11-15
Completion
2026-11-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728228 on ClinicalTrials.gov