Amnioinfusion for Fetal Renal Failure

Part of paid clinical trials in Dallas, Texas.

Sponsor
Fetal Care Center, PLLC
Study ID
NCT06728228
Status
Recruiting
Apply to this trial

Conditions

  • Anhydramnios
  • Bilateral Renal Agenesis
  • Fetal Renal Anomaly
  • Lower Urinary Tract Obstructive Syndrome
  • Lung Hypoplasia
  • Multicystic Dysplastic Kidney
  • Multicystic Renal Dysplasia, Bilateral
  • Polycystic Kidney Disease
  • Potter Syndrome

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 5, 2024
Status verified
Dec 2024
Primary completion
Nov 15, 2025
Completion
Nov 15, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Amnioinfusion
    Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.
  • No Intervention: Comfort Care/Expectant Management
    The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.

Primary Outcome Measure

Fetal Survival to Dialysis [ Time Frame: Birth to either survival to >=14 days and placement of dialysis access, or nonsurvival, up to 3 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fetal Care CenterDallasTexas75230
Kevin P Magee, M.D.
[email protected]
(972) 566-5600

Find similar trials in Dallas, TX

By research site
Fetal Care Center· Dallas, TX

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