Congenital Diaphragmatic HerniaFETONCT02986087
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
A study testing Fetal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary; Hypertension
- What is being tested?
- Fetal Tracheal Occlusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2026
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Isolated CDH with liver up
- Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
- Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery
- Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
- Maternal age greater than or equal to 18 years
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- Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
- Normal karyotype or FISH
- Normal fetal echocardiogram
- Singleton pregnancy
- Willing to remain in the greater Cincinnati area for remainder of pregnancy
- Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
- Family meets psychosocial criteria
Who cannot join
- Patient < 18 years old
- Multi-fetal pregnancy
- Rubber latex allergy
- Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Bilateral CDH, isolated left sided CDH with an O/E > 30%
- Additional fetal anomaly by ultrasound, MRI, or echocardiogram
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- Chromosomal abnormalities
- Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
- Incompetent cervix with or without a cerclage
- Placental abnormalities known at time of enrollment
- Maternal HIV, Hepatits B, Hepatitis C
- Maternal uterine anomaly
- 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, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, 45229
Foong-Yen Lim, MD, 513-803-5270, Foong.Yen.Lim@cchmc.org
Jose L Peiro, MD, PhD, MBA, 513-803-4563, jose.peiroibanez@cchmc.org
About this study
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Read the detailed description
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.
- Being tested
- Fetal Tracheal Occlusion
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Tracheal OcclusionDevice
Also called FETO, Fetal Endoluminal Tracheal Occlusion
Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Tracheal Occlusion | Experimental | Fetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth. Receives: Device: Fetal Tracheal Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change lung growth on prenatal imaging
Change in o/eLHR and other prenatal imaging tests
Measured: prenatal period up to 40 weeks gestation
Secondary outcomes (4)
Change survival in the severe congenital diaphragmatic hernia subgroup
Change rate of survival
Measured: 6 months
Change need for ECMO therapy
Change need for ECMO therapy
Measured: 6 months
Change pulmonary hypertension
Change pulmonary hypertension
Measured: 6 months
Change neonatal morbidity
Change neonatal morbidity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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 Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt Schibler, MD, Study chair, CCHMC Oversight Data Safety Monitoring Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986087
- Sponsor's protocol ID
- 2015-6413
- Acronym
- FETO
- Status last verified
- May 2025
- First submitted
- 6 Dec 2016
- Last updated
- 11 May 2025
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT02986087
- Acronym / sponsor ID
- FETO / 2015-6413
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- 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.
Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.
Detailed description
Fetuses with congenital diaphragmatic hernia with liver-up, and an observed to expected lung-to-head ratio of <25%, LHR <1, or a moderate category with o/e LHR <30%, singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days (severe), gestational age < 31 weeks 6 days (moderate), no maternal disease, maternal age > 18 years old…. meet criteria to be offered fetal tracheal occlusion. We want to test feasibility and efficacy in our center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Tracheal Occlusion | Experimental | Device: Fetal Tracheal OcclusionFetuses with severe or moderate congenital diaphragmatic hernia will be offered fetal tracheal occlusion to increase lung growth. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Isolated CDH with liver up
- Severe pulmonary hypoplasia with ultrasound O/E LHR <25% at the time of surgery
- Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
- Moderate pulmonary hypoplasia with ultrasound O/E LHR <30% and liver-up at the time of surgery
- Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
Key exclusion criteria (14 listed)
- Patient < 18 years old
- Multi-fetal pregnancy
- Rubber latex allergy
- Preterm labor, cervix shortened (<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Bilateral CDH, isolated left sided CDH with an O/E > 30%
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 |
|---|---|---|
| Fetal Tracheal OcclusionAlso: FETO, Fetal Endoluminal Tracheal OcclusionFetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center. | Device | Fetal Tracheal Occlusion |
Primary outcome
Change lung growth on prenatal imaging
Time frame: prenatal period up to 40 weeks gestation
Change in o/eLHR and other prenatal imaging tests
4 secondary outcomes
Change survival in the severe congenital diaphragmatic hernia subgroup
Time frame: 6 months
Change need for ECMO therapy
Time frame: 6 months
Change pulmonary hypertension
Time frame: 6 months
Change neonatal morbidity
Time frame: 1 year
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 11 May 2025.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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
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.
Kurt Schibler, MD study chair
CCHMC Oversight Data Safety Monitoring Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Pulmonary Hypoplasia, run by Children's Hospital Medical Center, Cincinnati 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 13 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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?
Contact Foong-Yen Lim, MD ((513) 636-6259, Foong-Yen.Lim@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change lung growth on prenatal imaging (time frame: prenatal period up to 40 weeks gestation). 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 11 May 2025.