An observational study in Congenital Diaphragmatic Hernia, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Mayo Clinic · Observational
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
Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.
Exclusion Criteria:
Psychosocial ineligibility, precluding consent:
Device: Fetoscopic Endoluminal Tracheal Occlusion
Other: Standard of Care
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.
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.
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.
Time frame: 2 years
Neonatal survival to discharge
Number of neonates to survive from delivery to hospital discharge
Time frame: 2 years
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
Time frame: 6, 12, 18, and 24 months of age
Need for supplemental oxygen
Number of infants to require supplemental oxygen
Time frame: 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
Time frame: 2 months
Intraventricular hemorrhage (grade 0-III)
Number of infants to be diagnosed with intraventricular hemorrhage (grade 0-III)
Time frame: 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)
Time frame: 6, 12, 18, and 24 months of age
Gastro-esophageal reflux
Number of infants to be diagnosed with gastro-esophageal reflux
Time frame: 6, 12, 18, and 24 months of age
Number of infant hospital readmissions
Number of infants readmitted to hospital after initial discharge
Time frame: 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.
Time frame: 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.
Time frame: 6, 12, 18, and 24 months of age
Bowel obstruction
Number of infants to experience a bowel obstruction.
Time frame: 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.
Time frame: 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.
Time frame: 6, 12, 18, and 24 months of age
Plan to share: No
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Hernias, Diaphragmatic, Congenital→
Mayo Clinic