Study of Metabolic, Phenotypic and Microbiome Profiling in Fetal Tracheal Aspirate and Amniotic Fluid after Fetal Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004201
Sponsor Protocol Number: 18-004201
About this study
The purpose of this study is to investigate the microbial, protein, genetic and cell profiles of the tracheal aspirates and amniotic fluid in human fetuses with congenital diaphragmatic hernia that undergo fetal therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Pregnant women age 18 years and older.
- Singleton pregnancy.
- Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26weeks.
- Isolated Left CDH with liver up.
- Gestation age at enrollment is less than or equal to 31 weeks plus 6 days as determined by clinical information (LMP) and evaluation of first ultrasound.
- In this study we will classify potential participants as either Extremely Severe CDH; Severe CDH; or CDH based on the O/E LHR:
- Extremely Severe CDH is defined as O/E LHR of <20%measured at 180 to 296 weeks;
- Severe CDH is defined as O/E LHR of 20% to <25% (measured at 180 to 296 weeks);
- CDH for the purposes of this study is defined as O/E LHR of 25% to <30% (measured at 18 to 31 weeks).
- Gestational age at FETO procedure will be
- at 22 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <20%
- at 27 weeks 0 days to 29 weeks 6 days for fetuses with O/E LHR <25%
- at 30 weeks 0 days to 31 weeks 6 days for fetuses with O/E LHR between 25% and <30%
- Patient meets psychosocial criteria.
- Informed consent.
Exclusion Criteria
- Pregnant women < 18 years.
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy.
- Technical limitations precluding fetoscopic surgery.
- History of natural rubber latex allergy.
- Preterm labor, cervix shortened (<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa.
- Psychosocial ineligibility, precluding consent.
- Diaphragmatic hernia: right-sided or bilateral, major associated anomalies, isolated left-sided with the O/E LHR ≥ 30%.
- Inability to remain at FETO site during time period of tracheal occlusion, delivery and postnatal care.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Rodrigo Ruano, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available