Neonatal Survival After Serial Amnioinfusions for Bilateral Renal Agenesis: The Renal Anhydramnios Fetal Therapy Trial.
Jena L Miller, Ahmet A Baschat, Mara Rosner...
https://pubmed.ncbi.nlm.nih.gov/38051327Actively Recruiting
Phase Not Applicable
FEMALE
ID06728228
Amnioinfusion for Fetal Renal Failure to Improve Survival and Lung Development
Led by Fetal Care Center, PLLC · Updated on 2024-12-20
35
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
F
Fetal Care Center, PLLC
Lead Sponsor
M
Medical City Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying fetuses with severe kidney failure that causes very low amniotic fluid, a condition called anhydramnios. This lack of fluid can harm lung development and lead to serious health problems or death shortly after birth. The study aims to find out if repeated amnioinfusions, which add fluid to the amniotic sac, can improve survival chances until dialysis or kidney transplant is possible. This research builds on earlier findings and seeks to improve outcomes for families facing this diagnosis. Participants will be divided into two groups: one receiving serial amnioinfusions with routine care, and a control group receiving comfort care without intervention. The amnioinfusions involve injecting sterile fluid into the amniotic cavity using a thin needle guided by ultrasound. The study team will perform these procedures at a specialized fetal care center, adjusting the number of infusions as needed. The trial also includes careful safety monitoring throughout pregnancy and after delivery. During the study, participants will have regular imaging tests like ultrasounds, echocardiograms, and MRIs, along with lab tests to monitor both the fetus and mother. Researchers will track fetal survival to dialysis and transplant, maternal safety up to 30 days after birth, and other pregnancy outcomes such as timing of membrane rupture and delivery. Follow-up will continue until at least two years after birth to assess transplant eligibility and long-term survival.
CONDITIONS
Brief Title
Amnioinfusion for Fetal Renal Failure
Who Can Participate
FEMALE
Eligibility Criteria
You may qualify if you...
- Confirmed anhydramnios before 22 weeks gestation for patients with fetal renal failure.
- Signed consent and first therapeutic amnioinfusion performed before 28 weeks and 6/7 days gestation.
- Expectant mother understands pregnancy management options.
- Age 18 years or older.
- Willingness to be followed and deliver at the Fetal Care Center and Medical City Dallas.
- Willingness for postnatal care at Medical City Dallas Hospital until maternal discharge.
- Consultations completed with Pediatric Nephrology, Neonatology, Transplant Surgery, Pediatric Surgery, Maternal-Fetal Medicine, and Genetic Counseling.
You will not qualify if you...
- Cervix length less than 2.5 cm.
- Presence of fatal chromosomal abnormalities such as trisomy 13 or 18, or fatal microarray findings excluding those related to pulmonary hypoplasia due to fetal renal failure.
- Other significant congenital anomalies in the fetus.
- Signs of chorioamnionitis or abruptio placentae.
- Evidence of rupture of membranes or chorionic-amniotic separation.
- Signs of preterm labor.
- Multiple pregnancies.
- Severe maternal medical conditions during pregnancy.
- Untreated or refractory maternal depression, psychosis, or anxiety.
- Technical issues preventing amnioinfusion procedures.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - From enrollment until delivery (up to approximately 9 months of pregnancy)
Participants in the experimental group receive serial amnioinfusion procedures to restore amniotic fluid levels in the womb, aiming to improve fetal lung development. Participants in the control group receive comfort care and expectant management without intervention.
Serial amnioinfusion procedures as deemed necessary by the study doctor; routine prenatal visits
Postnatal Follow-up
Duration - From delivery up to 2 years after birth
Participants and their newborns are monitored to assess maternal safety, fetal survival to dialysis, and survival to kidney transplant eligibility. Monitoring continues through delivery and up to 30 days postpartum for maternal safety, and up to 2 years after delivery for infant survival outcomes.
Follow-up visits for maternal safety up to 30 days postpartum; ongoing assessments for infant survival up to 2 years
Trial Site Locations
Total: 1 location
1
Fetal Care Center
Dallas, Texas, United States, 75230
Actively Recruiting
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Research Team
K
Kevin P Magee, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Amnioinfusions to Treat Early Onset Anhydramnios Caused by Renal Anomalies: Background and Rationale for the Renal Anhydramnios Fetal Therapy Trial.
Elizabeth M O'Hare, Angie C Jelin, Jena L Miller...
https://pubmed.ncbi.nlm.nih.gov/30897573