Renal Anhydramnios Fetal Therapy (RAFT) is a clinical trial focused on helping combat the effects of early pregnancy renal anhydramnios (EPRA). EPRA is a condition where there is no amniotic fluid around the fetus in the womb. It occurs either because the fetus does not have kidneys or the kidneys do not function, preventing the fetus from producing urine, which typically makes up most of the amniotic fluid. EPRA is thought to be universally fatal at birth because lungs cannot develop in utero without amniotic fluid.
RAFT is a non-randomized trial testing if serial amnioinfusions (a recently developed procedure in which a small needle is used to inject isotonic fluid into the amniotic cavity) can allow fetuses to develop enough lung function to live outside of the womb. Additionally, without functioning kidneys, the fetuses who survive after birth will require dialysis, a procedure to remove excess waste and fluid from the body in the event of kidney failure. The primary objective of the study is to determine the proportion of newborns surviving to successful dialysis.
BIOS CTCC and the Department of Pediatrics at the Johns Hopkins School of Medicine jointly act as the study coordinating and data management centers with support from the Trial Innovation Network. Funded by the National Institute of Child Health and Human Development, this study plans to enroll 140 participants across 7-15 sites within the United States.
ClinicalTrials.gov Identifier: NCT03101891