Using amnioinfusions to treat pulmonary hypoplasia in fetuses
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies- a Feasibility Study
This study is testing if giving extra fluid to pregnant women with fetuses that have severe urinary problems can help improve lung development and kidney function in newborns.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03723564 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of serial amnioinfusions in fetuses diagnosed with severe lower urinary tract obstruction (LUTO) or bilateral renal agenesis. The study will involve pregnant women with affected fetuses who will receive ultrasound-guided amnioinfusions to increase amniotic fluid levels, potentially reducing the severity of pulmonary hypoplasia. The trial will enroll a limited number of participants due to the rarity of these conditions, with a focus on monitoring outcomes over a two-year period. The goal is to assess whether this intervention can improve survival rates and renal function in newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old with fetuses under 26 weeks gestational age diagnosed with severe LUTO or bilateral renal agenesis.
Not a fit: Patients with associated fetal anomalies unrelated to LUTO or renal agenesis, or those with maternal conditions contraindicating surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly increase the survival chances and renal health of newborns affected by severe LUTO or bilateral renal agenesis.
How similar studies have performed: While the approach of using amnioinfusions is established, the specific application for pulmonary hypoplasia in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Mauro Schenone, MD — Mayo Clinic
- Study coordinator: Taylor M Rasmusson, MSN
- Email: Rasmusson.Taylor@mayo.edu
- Phone: 507-266-4813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.