Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia

NCT03723564 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 17-007726
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

bilateral renal agenesis; lower urinary tract obstruction; congenital renal anomalies; fetal surgery; amnioinfusion; fetus

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Total number of Adverse Events experienced

  First amnioinfusion through delivery which may be up to 22 weeks.

Secondary Outcomes (2)

• Survival to renal transplant

  5 years

• Survival to dialysis

  From time of birth up to one month

Study Arms (1)

Amnioinfusion

EXPERIMENTAL

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.

Drug: Lactated Ringers Solution for Injection

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

Also known as: Lactated Ringers Solution for Infusion

Amnioinfusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women with singleton uterine pregnancy
• Maternal age \> age 18
• Fetus \< 26 weeks gestational age with severe LUTO and intrauterine renal failure
• Fetus \< 26 weeks gestational age with bilateral renal agenesis
• Fetus with absence of chromosome abnormalities
• Fetus with absence of associated anomalies
• Mother has negative Hepatitis B, Hepatitis C, and HIV testing
• Mother meets psychosocial criteria that allows her to make a conscious decision about her fetus/infant

You may not qualify if:

• Associated fetal anomaly unrelated to LUTO or renal agenesis
• Increased risk for preterm labor including short cervical length, history of incompetent cervix with or without cerclage, and previous preterm birth
• Placental abnormalities known at time of enrollment
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal medical condition that is a contraindication to surgery or anesthesia
• Mother has declined invasive testing
• Inability to comply with the travel and follow-up requirements of the trial
• Participation in another interventional study that influences maternal and fetal morbidity and mortality
• Participation in this clinical trial during a previous pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hereditary renal agenesis; Congenital Abnormalities

Interventions

Ringer's Lactate; Injections

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor M Rasmusson, MSN

CONTACT

507-266-4813; Rasmusson.Taylor@mayo.edu

Jainnee McCann

CONTACT

507-538-5679; McCann.Jainnee@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 29, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-10

Locations

US (1)