Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Not Applicable

• Conditions: Congenital Diaphragmatic Hernia
• Interventions: Device: BALT GOLDBALL 2 detachable latex ballon; Device: BALTACCIBDPE100 Microcatheter; Device: Storz fetoscopic operating sheath and miniature telescope/fetoscope

• Registration Number: NCT05962346
• Lead Sponsor: Mauro H. Schenone

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Study Start: 2026-01
• Primary Completion: 2043-07
• Study Completion: 2043-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FETO Group	BALT GOLDBALL 2 detachable latex ballon	Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.
FETO Group	BALTACCIBDPE100 Microcatheter	Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.
FETO Group	Storz fetoscopic operating sheath and miniature telescope/fetoscope	Participants will undergo fetal endoscopic tracheal occlusion (FETO) surgical procedure between 27 weeks 0 days and 29 weeks 6 days gestation.

Primary Outcome Measures

Name	Time	Method
Technical success of balloon retrieval procedure	Up to 34 weeks gestation	The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.
Operative times	Up to 34 weeks gestation	FETO placement and release operative times reported in minutes
Technical success of the balloon placement procedure	Up to 29 weeks gestation	The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.
Number of incidences of maternal complications	Up to 41 weeks gestation	Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Gestational Age at Delivery	Up to 41 weeks gestation	Gestation Age reported at time of delivery
Frequency of unplanned balloon removal	Up to 34 weeks gestation	The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)

Secondary Outcome Measures

Name	Time	Method
Number of days of ventilator support	Up to 24 months post partum	Number of reported days infants required ventilator support
Number of periventricular leukomalacia at < 2 months postnatally	Up to 2 months post partum	Number of infants reported presence of periventricular leukomalacia at \< 2 months postnatally
Use of patch or muscle flap	Up to 24 months post partum	Number of infants reported to require the use of patch or muscle flap
Fetal Lung Growth as measured via Fetal Lung Volume	Up to 24 months post partum	Fetal Lung Volume as measured via ultrasound
Fetal Oxygen Dependency	Up to 24 months post partum	Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician
Fetal Survival	Up to 6 months post partum	Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized
Occurrence of severe pulmonary hypertension	Up to 24 months post partum	Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram
ECMO Support	Up to 24 months post partum	Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support
Number of days in NICU	Up to 24 months post partum	Number of days infant was in neonatal intensive care unit
Number of infant complications	Up to 24 months post partum	Number of infants reporting the presence of: neonatal sepsis, intraventricular hemorrhage (grade 3 or higher), retinopathy of prematurity (grade 3 or higher) or gastro-esophageal reflux
Maternal hospitalization	Up to 24 months post partum	Number of reported days of maternal hospitalization
Route of delivery	Day 1 (post partum)	Number of participants that delivered vaginally and via caesarean section
Fetal Lung Growth as measured via LHR	Up to 24 months post partum	Lung area to head circumference Ratio (LHR) as measured via ultrasound

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States