Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Congenital Diaphragmatic Hernia Clinical Trial

— FETO  

Official title:

Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion for Severe Left Congenital Diaphragmatic Hernia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05962346
• Other study ID #: 23-002166
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 2025
• Est. completion date: July 2043

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 2043
• Est. primary completion date: July 2043
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

Device:
• BALT GOLDBALL 2 detachable latex ballon
Inflated with fluid in the fetal trachea and provide with the occlusion necessary to promote lung growth.
• BALTACCIBDPE100 Microcatheter
Used to deliver the detachable balloon
• Storz fetoscopic operating sheath and miniature telescope/fetoscope
Used to percutaneously enter though the maternal abdominal wall, uterus and into the amniotic cavity, fetal mouth, pharynx, larynx, into the trachea where the delivery catheter will be used to deliver the detachable balloon that will provide with the tracheal occlusion.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mauro H. Schenone

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of the balloon placement procedure	The number of successful balloon placement procedures defined as balloon was correctly inflated and placed/secured in the trachea.	Up to 29 weeks gestation
Primary	Technical success of balloon retrieval procedure	The number of successful balloon retrieval procedure defined as antenatal removal of the balloon.	Up to 34 weeks gestation
Primary	Operative times	FETO placement and release operative times reported in minutes	Up to 34 weeks gestation
Primary	Frequency of unplanned balloon removal	The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)	Up to 34 weeks gestation
Primary	Number of incidences of maternal complications	Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis	Up to 41 weeks gestation
Primary	Gestational Age at Delivery	Gestation Age reported at time of delivery	Up to 41 weeks gestation
Secondary	Fetal Lung Growth as measured via Fetal Lung Volume	Fetal Lung Volume as measured via ultrasound	Up to 24 months post partum
Secondary	Fetal Lung Growth as measured via LHR	Lung area to head circumference Ratio (LHR) as measured via ultrasound	Up to 24 months post partum
Secondary	Fetal Survival	Survival at 30 days, discharge from the hospital and at 6 months if still hospitalized	Up to 6 months post partum
Secondary	Fetal Oxygen Dependency	Oxygen dependency graded as none, mild, moderate, severe as assessed by treating physician	Up to 24 months post partum
Secondary	Occurrence of severe pulmonary hypertension	Number of occurrence of severe pulmonary hypertension in infants based on echocardiogram	Up to 24 months post partum
Secondary	ECMO Support	Number of infants reported that required Extracorporeal membrane oxygenation (ECMO) support	Up to 24 months post partum
Secondary	Number of days in NICU	Number of days infant was in neonatal intensive care unit	Up to 24 months post partum
Secondary	Number of days of ventilator support	Number of reported days infants required ventilator support	Up to 24 months post partum
Secondary	Number of periventricular leukomalacia at < 2 months postnatally	Number of infants reported presence of periventricular leukomalacia at < 2 months postnatally	Up to 2 months post partum
Secondary	Number of infant complications	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	Up to 24 months post partum
Secondary	Use of patch or muscle flap	Number of infants reported to require the use of patch or muscle flap	Up to 24 months post partum
Secondary	Maternal hospitalization	Number of reported days of maternal hospitalization	Up to 24 months post partum
Secondary	Route of delivery	Number of participants that delivered vaginally and via caesarean section	Day 1 (post partum)