Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

Conditions

• Congenital Renal Anomaly Nos
• Lower Urinary Tract Obstructive Syndrome
• Renal Agenesis and Dysgenesis
• Renal Failure Congenital

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Lactated Ringers Solution for Injection — DRUG
  Using ultrasound guidance, a 22 gauge needle will be introduced into amniotic cavity. Warmed Lactated Ringers solution will be injected into the amniotic cavity until an AFI of 8.0 cm is achieved

Study Details

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.

Key Dates

Start date

Oct 1, 2018

Status verified

Oct 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Amnioinfusion
  Lactated Ringers Solution for Injection --- Serial ultrasound-guided amnioinfusion procedures will be performed on fetuses having severe LUTO or bilateral renal agenesis that are diagnosed between 18 0/7-25 6/7 weeks.

Primary Outcome Measure

Adverse Events [ Time Frame: First amnioinfusion through delivery which may be up to 22 weeks. ]

Central Contacts

• Taylor M Rasmusson, MSN
  507-266-4813
  [email protected]
• Jainnee McCann
  507-538-5679
  [email protected]

Locations (1)

Find similar trials in Rochester, MN

Related Studies

• Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction
  Recruiting · Rodrigo Ruano · Miami, Florida
• Amnioinfusion for Fetal Renal Failure
  Recruiting · Fetal Care Center, PLLC · Dallas, Texas