Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2024-12-05
2026-11-15
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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Amnioinfusion
Those in this experimental arm, Amnioinfusion, will undergo serial amnioinfusion in addition to routine care as deemed appropriate by the study doctor.
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.
Comfort Care/Expectant Management
The non-experimental arm, Comfort Care/Expectant Management, will undergo comfort care as elected by the participant.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
FEMALE
No
Sponsors
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Medical City Children's Hospital
OTHER
Medical City Women's Hospital
UNKNOWN
Fetal Care Center, PLLC
INDUSTRY
Responsible Party
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Locations
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Fetal Care Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Kevin P Magee, M.D.
Role: primary
References
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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.
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.
Related Links
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Renal Anhydramnios Fetal Therapy (RAFT) Trial Wesbite
Fetal Care Center - Amnioinfusion FAQ
Other Identifiers
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2063654
Identifier Type: -
Identifier Source: org_study_id