Congenital Diaphragmatic HerniaNCT07564297
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
An observational study of Congenital Diaphragmatic Hernia, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Fetoscopic Endoluminal Tracheal Occlusion
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 May 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Fetoscopic Endoluminal Tracheal Occlusion, Standard of Care
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetoscopic Endoluminal Tracheal OcclusionDevice
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FETO Surgery | Not described Receives: Device: Fetoscopic Endoluminal Tracheal Occlusion | |
| Standard of Care | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Neonatal survival to discharge
Number of neonates to survive from delivery to hospital discharge
Measured: 2 years
Secondary outcomes (12)
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
Measured: 6, 12, 18, and 24 months of age
Need for supplemental oxygen
Number of infants to require supplemental oxygen
Measured: 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
Measured: 2 months
Intraventricular hemorrhage (grade 0-III)
Number of infants to be diagnosed with intraventricular hemorrhage (grade 0-III)
Measured: 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)
Measured: 6, 12, 18, and 24 months of age
Gastro-esophageal reflux
Number of infants to be diagnosed with gastro-esophageal reflux
Measured: 6, 12, 18, and 24 months of age
Number of infant hospital readmissions
Number of infants readmitted to hospital after initial discharge
Measured: 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.
Measured: 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.
Measured: 6, 12, 18, and 24 months of age
Bowel obstruction
Number of infants to experience a bowel obstruction.
Measured: 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.
Measured: 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.
Measured: 6, 12, 18, and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 May 2036 (estimated)
- Study completion31 May 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564297
- Sponsor's protocol ID
- 25-007786
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT07564297
- Acronym / sponsor ID
- 25-007786
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 May 2036 (estimated)
- Study completion
- 31 May 2038 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FETO Surgery | – | Device: Fetoscopic Endoluminal Tracheal Occlusion |
| Standard of Care | – | Other: Standard of Care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant patients with fetuses affected by congenital diaphragmatic hernia meeting the inclusion criteria above-mentioned and not meeting exclusion criteria.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetoscopic Endoluminal Tracheal OcclusionMothers 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. | Device | FETO Surgery |
| Standard of CareMothers 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. | Other | Standard of Care |
Primary outcome
Number of FETO procedure complications
Time frame: 2 years
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.
Neonatal survival to discharge
Time frame: 2 years
Number of neonates to survive from delivery to hospital discharge
12 secondary outcomes
Presence of pulmonary hypertension
Time frame: 6, 12, 18, and 24 months of age
Need for supplemental oxygen
Time frame: 6, 12, 18, and 24 months of age
Periventricular leukomalacia at < 2 months postnatally
Time frame: 2 months
Intraventricular hemorrhage (grade 0-III)
Time frame: 6, 12, 18, and 24 months of age
Retinopathy of prematurity (grade 3 or higher)
Time frame: 6, 12, 18, and 24 months of age
Gastro-esophageal reflux
Time frame: 6, 12, 18, and 24 months of age
Number of infant hospital readmissions
Time frame: 6, 12, 18, and 24 months of age
Childhood growth failure
Time frame: 6, 12, 18, and 24 months of age
Recurrence of Congenital Diaphragmatic Hernia (CDH) repair
Time frame: 6, 12, 18, and 24 months of age
Bowel obstruction
Time frame: 6, 12, 18, and 24 months of age
Neurodevelopmental delay
Time frame: 6, 12, 18, and 24 months of age
Bronchopulmonary dysplasia
Time frame: 6, 12, 18, and 24 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
RecruitingPhase 4
De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Active, not recruiting
Fetoscopic Endoluminal Tracheal Occlusion (FETO) for Severe Left Diaphragmatic Hernia (CDH)
Congenital Diaphragmatic Hernia
Recruiting
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauro Schenone, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Hernia, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of FETO procedure complications (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.