North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia

The purpose of this research is to determine if babies who undergo a Fetoscopic Endoluminal Tracheal Occlusion (FETO) procedure survive more often and have less long-term complications than babies who have similarly severe Congenital Diaphragmatic Hernia (CDH) that have not had the FETO procedure performed during pregnancy

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Diaphragmatic Hernia
• Intervention / Treatment: Device: Fetoscopic Endoluminal Tracheal Occlusion; Other: Standard of Care

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: OB/GYN Clinical Research Team, Krista Storing; Phone Number: 507-266-3382
• Study Contact Backup: Name: OB/GYN Clinical Research Team, Krista Storing

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.

Description

Inclusion Criteria:

• Singleton pregnancy
• Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is > 26 weeks
• Gestational age at enrollment prior to 29 6/7 weeks
• Intrathoracic liver herniation Isolated left CDH with O/E LHR < 30% at enrollment (18 0/7 to 29 5/7 weeks.) Isolated right CDH with O/E LHR < 45% at enrollment (18 0/7 to 29 5/7 weeks).
• Cervical length by transvaginal ultrasound > 20 mm within 24 to 48 hours prior to FETO procedure
• Patient meets psychosocial criteria
• Informed consent understood

Exclusion Criteria:

• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, cervix shortened (<20 mm at enrollment or within 24 to 48 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa

• Psychosocial ineligibility, precluding consent:

  • Inability to reside within 30 minutes of Mayo Clinic. 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.
• Bilateral CDH, isolated left sided CDH with O/E LHR 30% (measured at 180 to 295 weeks), isolated right sided CDH with O/E LHR > 45% (measured at 180 to 295 weeks), as determined by ultrasound.
• No intrathoracic liver herniation
• Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center.
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• 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 because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
• Uterine anomaly such as large or multiple fibroids or Mullerian duct abnormality
• There is 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care	Other: Standard of Care; Mothers who chose to receive expectant management for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.
FETO Surgery	Device: Fetoscopic Endoluminal Tracheal Occlusion; Mothers who chose to undergo a Fetoscopic Endoluminal Tracheal Occlusion procedure for severe left and right congenital diaphragmatic hernia will be followed until the infant is 2 years of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of FETO procedure complications	FETO procedure complications are defined as device dislodgement, intraoperative injury to fetus, procedural hemorrhage, post-procedural hemorrhage, preterm delivery, chorioamnion separation, chorioamnionitis, polyhydramnios, oligohydramnios, failed percutaneous or fetoscopic removal requiring cesarean section or EXIT procedure for removal, neonatal death due to asphyxia (if delivery before FETO removal), non-reassuring fetal heart rate monitoring.	2 years
Neonatal survival to discharge	Number of neonates to survive from delivery to hospital discharge	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for supplemental oxygen	Number of infants to require supplemental oxygen	6, 12, 18, and 24 months of age
Periventricular leukomalacia at < 2 months postnatally	Number of infants to be diagnosed with periventricular leukomalacia at < 2 months postnatally	2 months
Intraventricular hemorrhage (grade 0-III)	Number of infants to be diagnosed with intraventricular hemorrhage (grade 0-III)	6, 12, 18, and 24 months of age
Retinopathy of prematurity (grade 3 or higher)	Number infants to be diagnosed with retinopathy of prematurity (grade 3 or higher)	6, 12, 18, and 24 months of age
Gastro-esophageal reflux	Number of infants to be diagnosed with gastro-esophageal reflux	6, 12, 18, and 24 months of age
Number of infant hospital readmissions	Number of infants readmitted to hospital after initial discharge	6, 12, 18, and 24 months of age
Childhood growth failure	Number of infants to experience childhood growth failure: weight gain velocity or decline >2 in weight, for length Z score.	6, 12, 18, and 24 months of age
Recurrence of Congenital Diaphragmatic Hernia (CDH) repair	Number of infants to require additional congenital diaphragmatic hernia (CDH) repair procedures.	6, 12, 18, and 24 months of age
Bowel obstruction	Number of infants to experience a bowel obstruction.	6, 12, 18, and 24 months of age
Neurodevelopmental delay	Number of infants to experience neurodevelopmental delay: Bayley Scales of Infant and Toddler Development-III(BSID)>2 SD below mean, or other categorization at 24 months.	6, 12, 18, and 24 months of age
Bronchopulmonary dysplasia	Number of infants to be diagnosed with bronchopulmonary dysplasia (BPD). It is defined according to the mode of respiratory support administered at 36 weeks' postmenstrual age, regardless of the prior duration or current level of oxygen therapy. The optimal diagnostic criteria will be no BPD, no support; grade 1 BPD, nasal cannula S2 L/min; grade 2 BPD, nasal cannula >2 L/min or noninvasive positive airway pressure; and grade 3 BPD, invasive mechanical ventilation.	6, 12, 18, and 24 months of age
Presence of pulmonary hypertension	Number infants to be diagnosed with pulmonary hypertension. Pulmonary hypertension is a determination of the ratio of the tricuspid regurgitation jet (estimation of the right ventricular systolic pressure) to systemic blood. Will be record as absent/none, systemic or suprasystemic	6, 12, 18, and 24 months of age

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mauro Schenone, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2036
• Study Completion (Estimated): May 31, 2038

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Internal Hernia; Pathological Conditions, Anatomical; Congenital Abnormalities; Hernia; Hernia, Diaphragmatic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hernias, Diaphragmatic, Congenital; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 25-007786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes