Clinical trial NCT05962346: Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
Official title: Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to gather information on the safety and effectiveness of a procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO) at Mayo Clinic. The intent of the FETO procedure is to improve development of the lungs in fetuses diagnosed with severe congenital diaphragmatic hernia (CDH).


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Normal fetal karyotype or microarray. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks
* Isolated severe left CDH with O/E LHR \< 25% )
* Gestation age at enrollment prior to 29 wks plus 6 days.
* Pulmonary hypoplasia with ultrasound O/E LHR \< 25% (measured at 18 0/7 to 29 5/7 weeks) at the time of surgery.
* Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
* Patient meets psychosocial criteria: able to reside within 30 minutes of Mayo Clinic, Rochester and able to comply with the travel for the follow-up requirements of the trial; patient has a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
* Patient is willing and able to give informed consent
* Appropriate multi-disciplinary counseling performed with maternal-fetal medicine, neonatology, pediatric surgery, genetics, pediatric otolaryngology (ENT)

Exclusion Criteria:

* Multi-fetal pregnancy
* History of natural rubber latex allergy
* Preterm labor, cervix shortened (\<20 mm) at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor
* Psychosocial ineligibility, precluding consent: inability to reside within 30 minutes of Mayo Clinic, Rochester and inability to comply with the travel for the follow-up requirements of the trial; patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Mayo Clinic
* Right sided CDH or bilateral CDH, isolated left sided with O/E LHR \>25% measured at 18 0/7 to 29 6/7 weeks) as determined by ultrasound
* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis. No cases will be removed post hoc if abnormalities are discovered in the course of post-operative monitoring
* Maternal contraindication to fetoscopic surgery
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accreta) known at time of enrollment
* Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Maternal HIV, Hepatitis-B, Hepatitis-C status positive.
* Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality that will make the procedure technically unfeasible
* No safe or technically feasible fetoscopic approach to balloon placement
* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Primary outcomes:
measure: Technical success of the balloon placement procedure
timeFrame: Up to 29 weeks gestation
measure: Technical success of balloon retrieval procedure
timeFrame: Up to 34 weeks gestation
measure: Operative times
timeFrame: Up to 34 weeks gestation
measure: Frequency of unplanned balloon removal
timeFrame: Up to 34 weeks gestation
measure: Number of incidences of maternal complications
timeFrame: Up to 41 weeks gestation
measure: Gestational Age at Delivery
timeFrame: Up to 41 weeks gestation
Secondary outcomes:
measure: Fetal Lung Growth as measured via Fetal Lung Volume
timeFrame: Up to 24 months post partum
measure: Fetal Lung Growth as measured via LHR
timeFrame: Up to 24 months post partum
measure: Fetal Survival
timeFrame: Up to 6 months post partum
measure: Fetal Oxygen Dependency
timeFrame: Up to 24 months post partum
measure: Occurrence of severe pulmonary hypertension
timeFrame: Up to 24 months post partum
measure: ECMO Support
timeFrame: Up to 24 months post partum
measure: Number of days in NICU
timeFrame: Up to 24 months post partum
measure: Number of days of ventilator support
timeFrame: Up to 24 months post partum
measure: Number of periventricular leukomalacia at < 2 months postnatally
timeFrame: Up to 2 months post partum
measure: Number of infant complications
timeFrame: Up to 24 months post partum
measure: Use of patch or muscle flap
timeFrame: Up to 24 months post partum
measure: Maternal hospitalization
timeFrame: Up to 24 months post partum
measure: Route of delivery
timeFrame: Day 1 (post partum)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mauro Schenone, MD
role: PRINCIPAL_INVESTIGATOR
References: