Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Congenital lower urinary tract obstruction (LUTO) is a heterogeneous group of congenital
anomalies that lead bladder outlet obstruction. If a complete obstruction is present, the
perinatal mortality is estimated to be as high as 90% because of severe pulmonary hypoplasia
due to the lack of amniotic fluid. Survivors have significant risk of renal impairment (90%)
requiring dialysis or renal transplantation if no fetal intervention is performed.
Renal agenesis is the congenital absence of one or both kidneys due to complete failure of
the kidney to form. As many as 33% of fetuses with bilateral renal agenesis are stillborn,
and the rest of them die immediately after birth due to severe pulmonary hypoplasia.
The objective of the serial amnioinfusions for fetuses with these conditions will be to
reduce the severity of pulmonary hypoplasia (regenerating the lung functionality) and
therefore increase the chance that the newborn survives to begin peritoneal dialysis.
Although there is initial evidence that serial amnioinfusions are feasible for the pregnant
women and the fetuses, there is still a need to have a prospective clinical trial to confirm
the hypothesis that serial amnioinfusions could prevent severe pulmonary hypoplasia allowing
the newborns with bilateral renal agenesis or severe LUTO to survive to begin peritoneal
dialysis.
Therefore, the investigators aim to study the hypothesis that serial amnioinfusions for
fetuses with severe LUTO and renal failure and those with bilateral renal agenesis will
reduce the severity of pulmonary hypoplasia and therefore increase the chance that the
newborn survives to begin peritoneal dialysis.