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
Led by Fetal Care Center, PLLC · Updated on 2024-12-20
35
Participants Needed
1
Research Sites
101 weeks
Total Duration
F
Fetal Care Center, PLLC
Lead Sponsor
M
Medical City Children's Hospital
Collaborating Sponsor
Researchers are investigating whether serial amnioinfusion can improve survival for fetuses with severe kidney failure that causes a lack of amniotic fluid, a condition called anhydramnios. This lack of fluid can prevent proper lung development, leading to serious health problems and often neonatal death. The study focuses on determining if adding fluid through amnioinfusion can increase chances of survival until the fetus can receive dialysis or a kidney transplant. This trial builds on earlier research suggesting potential benefits of this treatment for fetal renal failure (FRF). Pregnant individuals with singleton pregnancies affected by FRF and anhydramnios will be enrolled and split into two groups: one receiving serial amnioinfusions using a spinal needle to inject sterile isotonic fluid into the amniotic sac under ultrasound guidance, and a control group receiving comfort care without intervention. The amnioinfusions are performed by fetal procedure experts as needed, based on regular monitoring. The study includes a thorough monitoring plan to ensure maternal safety and track fetal and maternal responses through imaging and lab tests. Participants will be closely followed by a specialized fetal care team and deliver at a designated hospital. Assessments include fetal survival to dialysis and transplant eligibility, as well as monitoring maternal treatment-related side effects from enrollment through delivery and up to 30 days postpartum. Data collected will help evaluate the safety and effectiveness of serial amnioinfusion and may guide future treatments for fetal kidney failure conditions.
CONDITIONS
Amnioinfusion for Fetal Renal Failure
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Total: 1 location
1
Fetal Care Center
Dallas, Texas, United States, 75230
Actively Recruiting
K
Kevin P Magee, M.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jena L Miller, Ahmet A Baschat, Mara Rosner...
https://pubmed.ncbi.nlm.nih.gov/38051327Elizabeth M O'Hare, Angie C Jelin, Jena L Miller...
https://pubmed.ncbi.nlm.nih.gov/30897573