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NCT06281717

Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia

Sponsor: Alireza Shamshirsaz

View on ClinicalTrials.gov

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.

Official title: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses with Severe Congenital Diaphragmatic Hernia

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-01

Completion Date

2031-02-28

Last Updated

2024-09-26

Healthy Volunteers

Conditions

Congenital Diaphragmatic Hernia

Interventions

DEVICE

Fetal Endotracheal Occlusion (FETO)

The FETO insertion procedure will be performed between gestational age 27 weeks 0 days and 29 weeks and 6 days. The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States