Clinical trial NCT06281717: Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia
Official title: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Keywords: Hernias, Diaphragmatic, Congenital
Fetoscopic Endoluminal Tracheal Occlusion
Fetal Endoscopic Tracheal Occlusion
Hernia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.

This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.

Detailed description: The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital diaphragmatic hernia (CDH). CDH is a condition in which the diaphragm fails to completely close, leaving a gap through which abdominal organs can herniate and slide into and out of the chest. In severe cases, abdominal organs move into the chest and stay there, putting pressure on the heart and lungs and potentially causing the disruption or deformation of these structures. Impaired development of the lungs can often lead to a condition known as pulmonary hypertension, a form of high blood pressure that damages the heart. Pulmonary hypoplasia and pulmonary hypertension can be lethal. Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year.

FETO will be performed with the goal of promoting lung growth and improving neonatal outcomes. FETO is a minimally invasive procedure in which a balloon device is inserted into the trachea of the fetus. The devices involved are the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100). The balloon would be left in place for several weeks and allow the lungs to grow, after which it would be removed, enabling the lungs to mature before birth. Participants will continue to be monitored up until the child reaches 2 years of age in order to assess mental and physical development after FETO.

Eligibility criteria: Inclusion Criteria:

* Pregnant patient 18 and older who is able to consent
* Singleton pregnancy
* Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal
* Patient has a support person who is able to stay with them for the duration of the pregnancy

Fetal:

* Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants
* Diagnosis of isolated left CDH with liver up
* Gestation at enrollment prior to 29 weeks 5 days
* SEVERE pulmonary hypoplasia with ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) \< 25%

Exclusion Criteria:

* Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
* Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly
* Latex allergy
* Preterm labor, shortened cervix (\<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
* Severe maternal obesity pre-pregnancy (BMI \> 40)
* Psychosocial ineligibility, precluding consent, as determined by clinic social worker during review
* Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care
* Right-sided or bilateral, left-sided CDH observed-to-expected lung to head ratio \> 25% on ultrasound
* Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis
* History of incompetent cervix with or without cerclage
* Placental abnormalities (previa, abruption, accreta) known at time of enrollment
* Maternal-fetal RH (rhesus) isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
* Maternal HIV, Hepatitis B, Hepatitis C status positive

Primary outcomes:
measure: Successful Ballon Placement
timeFrame: Gestational age of 27 weeks 0 days to 29 weeks 6 days
measure: Successful Balloon Removal
timeFrame: Prior to delivery, ideally at 34 weeks
measure: Balloon placement operative time
timeFrame: Gestational age of 27 weeks 0 days to 29 weeks 6 days
measure: Balloon removal operative time
timeFrame: Prior to delivery, ideally at 34 weeks
measure: Type of FETO release
timeFrame: Prior to delivery, ideally at 34 weeks
measure: Maternal Complications
timeFrame: From balloon placement to delivery
measure: Gestational age at delivery
timeFrame: At delivery
Secondary outcomes:
measure: Fetal lung volume
timeFrame: Once per week from balloon placement to removal. This measure will be recorded at earliest gestational age of 27 weeks 0 days, and latest at 34+6/7 weeks' gestation.
measure: Observed-to-Expected Lung to Head Ratio
timeFrame: Calculated at balloon removal, ideally at 34 weeks gestation
measure: Infant survival
timeFrame: At hospital discharge or 6 months of age, whichever comes first. Hospital discharge typically occurs at 2-3 months of age
measure: Oxygen dependency
timeFrame: At time of discharge, on average at 2-3 months of age
measure: Number of infants requiring ECMO (extracorporeal membrane oxygenation)
timeFrame: Birth to 6 months
measure: NICU (neonatal intensive care unit) stay
timeFrame: From birth until discharge, at an average of 2-3 months of age
measure: Ventilator support
timeFrame: Up to 2 years of age
measure: Presence of periventricular leukomalacia
timeFrame: From birth until 2 months of age
measure: Presence of neonatal sepsis
timeFrame: From birth until 1 month of age
measure: Presence of intraventricular hemorrhage
timeFrame: Up to 2 years of age
measure: Retinopathy of prematurity
timeFrame: From birth to 1 month of age
measure: Presence of gastro-esophageal reflux
timeFrame: From birth until 2 years of age
measure: CDH repair type
timeFrame: Postnatal, at time of CDH repair, typically within 2 weeks of birth
measure: Pulmonary function
timeFrame: At discharge around 2-3 months and at one year of age
measure: Infant Neurodevelopment
timeFrame: At 6 months, 12 months, and 24 months of age
measure: Route of delivery
timeFrame: At delivery
measure: Maternal hospitalization
timeFrame: From delivery until discharge, around 2-3 months of age
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Director, Maternal Fetal Care Center
name: Alireza Shamshirsaz, MD
role: PRINCIPAL_INVESTIGATOR
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