Congenital Diaphragmatic HerniaFETONCT00881660
Fetal Endotracheal Occlusion (FETO) in Severe and Extremely Severe Congenital Diaphragmatic Hernia
A study testing Goldballoon Detachable Balloon and delivery microcatheter in people with Congenital Diaphragmatic Hernia, run by Michael A Belfort at 1 site in United States.
Trial summary
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Goldballoon Detachable Balloon and delivery microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2012to 11 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient is a pregnant woman between 18 and 45 years of age
- Singleton pregnancy
- Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus
- Severe CDH: -Fetal liver herniated into the hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation
- Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is < 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation
- Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome
Show all 11Show fewer
- Normal fetal karyotype
- The mother must be healthy enough to have surgery
- Patient provides signed informed consent that details the maternal and fetal risks involved with the procedure
- Patient willing to remain in Houston for the duration following the balloon placement until delivery
- Signed informed consent
Who cannot join
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy to latex
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
- Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation
- Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI
- Maternal BMI >40
- High risk for fetal hemophilia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.
Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.
Read the detailed description
Enrollment
Women carrying fetuses with severe or extremely severe CDH and a normal karyotype will undergo routine clinical evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH. They will have ultrasound and/or MRI evaluation to rule out other anomalies, calculation of the LHR from ultrasound measurements, echocardiography, and detailed obstetric/perinatal consultation. Patients who meet the eligibility criteria will be extensively counseled, and those who wish to participate will provide written, informed consent for the study.
Procedure
The procedure will be performed under spinal anesthesia or local anesthesia with intravenous sedation. The technique of fetal endoscopic tracheal occlusion has been described. Using standard technique, a cannula loaded with a pyramidal trocar will be inserted into the amniotic cavity and a fetoscope or flexible operating endoscope will be passed through the cannula into the amniotic fluid. If, upon evaluation, the baby cannot be accessed through the way just described above, the uterus will be accessed through an incision in the belly (called a laparotomy). A laparotomy is a surgical technique that makes an incision in the abdomen. After the incision has been made, the uterus will be temporarily repositioned externally. The baby will then be accessed using the fetoscope and ultrasound, as described above. The laparotomy will only be done if the baby cannot be reached and repositioned to a more favorable one by doing external maneuvers (called external version) for the FETO procedure.
The scope will be guided into the fetal larynx either through a nostril and then via the nasal passage or through the fetal mouth, and then through the fetal vocal cords with the aid of both direct vision through the scope and cross-sectional ultrasonographic visualization. A detachable latex balloon will be placed in the fetal trachea midway between the carina and the vocal cords. The balloon will be inflated with isosmotic contrast material so that it fills the fetal trachea.
Postoperative
The mothers will be discharged once stable. Serial measurements of sonographic lung volume and LHR will begin within 24-48 hours following surgery and continue weekly by targeted ultrasound evaluation. Amniotic fluid level and membrane status will also be monitored at weekly intervals. Comprehensive ultrasonography for fetal growth will be performed every four weeks (+/- 1 wk). All discharged patients will stay within 30 minutes of TCH to permit standardized postoperative management and emergent retrieval of the balloon in the event of preterm labor or premature rupture of membranes prior to the scheduled removal.
After the FETO surgery, prior to leaving the hospital, the mother will be given a medical alert bracelet identifying her as a patient with a baby with blocked airways. She will be encouraged to wear the bracelet at all times so that in case of emergency, she and others will know who to contact. She will also be given a pamphlet with instructions for medical personnel describing how to remove the balloon in case of an emergency. She should carry it with her at all times.
Balloon retrieval will be planned at between 32+0/7 and 34+6/7 weeks or no longer than 10 wks after placement, at the discretion of the FETO center. The patient will need to commit to remaining in 30 minutes of Texas Children's Hospital Pavilion for Women until the balloon is retrieved. In the event of a patient relocating after having the balloon placed, despite having committed to remain in the area during consent process, she will be asked to return for the removal. Every effort to make arrangements for her to be managed by the nearest center capable of an EXIT procedure or balloon retrieval (San Francisco or Philadelphia) will be made.
After removal of the balloon, patients will have the choice of delivering at Texas Children's Hospital- Women's Pavilion with the CDH managed and repaired at TCH, or returning to their obstetrician for delivery with subsequent repair of the CDH by the pediatric surgeons at their referring facility. Given the severity of the CDH, the baby will need to be delivered in a facility that has the capability of immediate pediatric surgery services.
We will need to monitor the baby at regular intervals (at 6 weeks, 3 months, 6 months, 1 year, and 2 years) after delivery to see how well the baby is breathing and how well the baby is developing. These check- ups may be at Texas Children's Hospital- Women's Pavilion or can be coordinated with other doctors of the participant's choosing.
If the child continues care at another institution, we will attempt to follow up with a review of the child's medical records.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Goldballoon Detachable Balloon and delivery microcatheter
- Keywords
- Fetal Tracheal Occlusion, congenital diaphragmatic hernia, FETO plug-unplug, Goldvalve balloon, Severe Congenital Diaphragmatic Hernia, Extremely Severe Congenital Diaphragmatic Hernia, Goldbal balloon, FETO
- 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.
Goldballoon Detachable Balloon and delivery microcatheterDevice
Also called GOLDBAL4 or GOLDBAL2 Goldballoon, BALTACCIBDPE100 delivery microcatheter
Between 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Endotracheal Occlusion | Experimental | Placement and retrieval of the GoldBAL4 or GoldBal2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter. Receives: Device: Goldballoon Detachable Balloon and delivery microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Survival
To assess two-year neonatal survival following FETO.
Measured: 2 years after childbirth.
Secondary outcomes (21)
Successful completion of surgical procedures/balloon placement
To assess the successful completion of surgical procedures/placement of balloons in fetuses with severe or extremely severe CDH.Case report forms are utilized to record study related data, including any procedural complications such as failed balloon placement or failed balloon retrieval, as well as surgical or anesthesia complications. At least twice a month fetal surveillance will be performed for up to 10 weeks post balloon placement.
Measured: Up to 10 weeks.
Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of preterm delivery (spontaneous or indicated).
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity-incidence of cesarean section
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of cesarean section rate.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity-length of hospitalization
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of length of hospitalization after the FETO procedure.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- length of hospitalization after UNPLUG procedure
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of length of hospitalization after balloon removal (UNPLUG)
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- vaginal bleeding
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post procedure vaginal bleeding.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- Placental abruption
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure placental abruption.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- Rupture of membranes
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure rupture of membranes. Amniotic fluid level and membrane status will also be monitored at weekly intervals by ultrasonography.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- oligohydramnios
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure oligohydramnios.Amniotic fluid level and membrane status will also be monitored at weekly intervals by ultrasonography.
Measured: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- chorioamnionitis
Case report forms are utilized to record study related data through patient's medical chart review. Maternal morbidity will be assessed in terms of incidence of post-procedure chorioamnionitis.
Measured: Up to 6 weeks postpartum
Neonatal/Child outcomes- Pulmonary Morbidity - ECMO
Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the need for extracorporeal membrane oxygenation.
Measured: Up to 2 years of age
Neonatal/Child outcomes- Pulmonary Morbidity- ventilatory support
Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the duration of neonatal ventilatory support.
Measured: Up to 2 years of age
Neonatal/Child outcomes- Pulmonary Morbidity- Supplemental oxygen
Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neonatal pulmonary morbidity, including the need for administration of supplemental oxygen.
Measured: Up to 2 years of age
Neonatal/Child outcomes- gastrointestinal morbidity
Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of gastrointestinal morbidity.
Measured: Up to 2 years of age
Neonatal/Child outcomes-neurologic morbidity
Case report forms are utilized to record study related data through patient's medical chart. Short-term measures of neurologic morbidity.
Measured: Up to 2 years of age
Neonatal/Child outcomes- Survival to discharge from the hospital
Case report forms are utilized to record study related data through patient's medical chart. Survival to discharge from the hospital.
Measured: Up to 2 years of age
Neonatal/Child outcomes- Duration of hospitalization.
Case report forms are utilized to record study related data through patient's medical chart. Duration of hospitalization after delivery.
Measured: Up to 2 years of age
Neonatal/Child outcomes- need for supplemental oxygen
Case report forms are utilized to record study related data through patient's medical chart. Assessments of measures of long-term morbidity as the need for supplemental oxygen.
Measured: Up to 18 years of age
Neonatal/Child outcomes- recurrent infection
Case report forms are utilized to record study related data through patient's medical chart. Assessments of measures of long-term morbidity as the rates of recurrent infection.
Measured: Up to 18 years of age
Neonatal/Child outcomes- repeated hospitalization
Case report forms are utilized to record study related data through patient's medical chart. Assessments measures of long-term morbidity as the need for repeated hospitalization. A general health questionnaire will also be given in the form of an interview, either face to face or over the phone. The questionnaire contains questions regarding the children's health status; including hospitalizations, medications, surgical procedures, medical interventions and additional therapies he/she is receiving, and questions to evaluate his/her behavioral and social development.
Measured: Up to 18 years of age
Neonatal/Child outcomes- Neurodevelopmental
DP-3 questionnaire will be utilized to record study related data. Assessments of neurodevelopmental outcomes.
Measured: Up to 18 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study start21 Feb 2012
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A Belfort
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Michael Belfort, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881660
- Sponsor's protocol ID
- H-28021
- Acronym
- FETO
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2009
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Deprest J, Jani J, Gratacos E, Vandecruys H, Naulaers G, Delgado J, Greenough A, Nicolaides K; FETO Task Group. Fetal intervention for congenital diaphragmatic hernia: the European experience. Semin Perinatol. 2005 Apr;29(2):94-103. doi: 10.1053/j.semperi.2005.04.006.
PubMed 16050527Deprest J, Jani J, Van Schoubroeck D, Cannie M, Gallot D, Dymarkowski S, Fryns JP, Naulaers G, Gratacos E, Nicolaides K. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia. J Pediatr Surg. 2006 Feb;41(2):423-30. doi: 10.1016/j.jpedsurg.2005.11.036.
PubMed 16481263Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.
PubMed 18634116Saura L, Castanon M, Prat J, Albert A, Caceres F, Moreno J, Gratacos E. Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. Eur J Pediatr Surg. 2007 Dec;17(6):404-7. doi: 10.1055/s-2007-989275.
PubMed 18072025Deprest JA, Hyett JA, Flake AW, Nicolaides K, Gratacos E. Current controversies in prenatal diagnosis 4: Should fetal surgery be done in all cases of severe diaphragmatic hernia? Prenat Diagn. 2009 Jan;29(1):15-9. doi: 10.1002/pd.2108. No abstract available.
PubMed 19125386Kohl T, Gembruch U, Tchatcheva K, Schaible T. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia by Deprest et al (J Ped Surg 2006;41:423-30). J Pediatr Surg. 2006 Jul;41(7):1344-5; author reply 1345-6. doi: 10.1016/j.jpedsurg.2006.04.001. No abstract available.
PubMed 16818078Harrison MR, Adzick NS, Estes JM, Howell LJ. A prospective study of the outcome for fetuses with diaphragmatic hernia. JAMA. 1994 Feb 2;271(5):382-4.
PubMed 8054005Belfort MA, Olutoye OO, Cass DL, Olutoye OA, Cassady CI, Mehollin-Ray AR, Shamshirsaz AA, Cruz SM, Lee TC, Mann DG, Espinoza J, Welty SE, Fernandes CJ, Ruano R. Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia. Obstet Gynecol. 2017 Jan;129(1):20-29. doi: 10.1097/AOG.0000000000001749.
PubMed 27926636
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Effectiveness of Fetal Endotracheal Occlusion (FETO) in the Management of Severe and Extremely Severe Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT00881660
- Acronym / sponsor ID
- FETO / H-28021
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- Fetal Tracheal Occlusion, congenital diaphragmatic hernia, FETO plug-unplug, Goldvalve balloon, Severe Congenital Diaphragmatic Hernia, Extremely Severe Congenital Diaphragmatic Hernia, Goldbal balloon, FETO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Michael A BelfortUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 21 Feb 2012 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 15 Apr 2009 (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.
Congenital diaphragmatic hernia (CDH) occurs when the diaphragm fails to fully fuse and leaves a portal through which abdominal structures can migrate into the thorax. In the more severe cases, the abdominal structures remain in the thoracic cavity and compromise the development of the lungs. Infants born with this defect have a decreased capacity for gas exchange; mortality rates after birth have been reported between 40-60%. Now that CDH can be accurately diagnosed by mid-gestation, a number of strategies have been developed to repair the hernia and promote lung tissue development.
Fetal tracheal occlusion is one technique that temporarily closes the herniated area with the Goldvalve balloon to allow the lungs to develop and increase survival at birth. This is a pilot study of a cohort of fetuses affected by severe CDH that will undergo FETO to demonstrate the feasibility of performing the procedure, managing the pregnancy during the period of tracheal occlusion, and removal of the device prior to delivery at BCM/Texas Children's Hospital (TCH). It is anticipated that fetal tracheal occlusion plug-unplug procedure will improve mortality and morbidity outcomes as compared with current management, but this is not a primary endpoint of the feasibility study. We will perform 20 FETO procedures on fetuses diagnosed prenatally with severe and extremely severe CDH.
Detailed description
Enrollment
Women carrying fetuses with severe or extremely severe CDH and a normal karyotype will undergo routine clinical evaluation. The fetuses will be 27+0/7 to 29+6/7 weeks of gestational age for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH. They will have ultrasound and/or MRI evaluation to rule out other anomalies, calculation of the LHR from ultrasound measurements, echocardiography, and detailed obstetric/perinatal consultation. Patients who meet the eligibility criteria will be extensively counseled, and those who wish to participate will provide written, informed consent for the study.
Procedure
The procedure will be performed under spinal anesthesia or local anesthesia with intravenous sedation. The technique of fetal endoscopic tracheal occlusion has been described. Using standard technique, a cannula loaded with a pyramidal trocar will be inserted into the amniotic cavity and a fetoscope or flexible operating endoscope will be passed through the cannula into the amniotic fluid. If, upon evaluation, the baby cannot be accessed through the way just described above, the uterus will be accessed through an incision in the belly (called a laparotomy). A laparotomy is a surgical technique that makes an incision in the abdomen. After the incision has been made, the uterus will be temporarily repositioned externally. The baby will then be accessed using the fetoscope and ultrasound, as described above. The laparotomy will only be done if the baby cannot be reached and repositioned to a more favorable one by doing external maneuvers (called external version) for the FETO procedure.
The scope will be guided into the fetal larynx either through a nostril and then via the nasal passage or through the fetal mouth, and then through the fetal vocal cords with the aid of both direct vision through the scope and cross-sectional ultrasonographic visualization. A detachable latex balloon will be placed in the fetal trachea midway between the carina and the vocal cords. The balloon will be inflated with isosmotic contrast material so that it fills the fetal trachea.
Postoperative
The mothers will be discharged once stable. Serial measurements of sonographic lung volume and LHR will begin within 24-48 hours following surgery and continue weekly by targeted ultrasound evaluation. Amniotic fluid level and membrane status will also be monitored at weekly intervals. Comprehensive ultrasonography for fetal growth will be performed every four weeks (+/- 1 wk). All discharged patients will stay within 30 minutes of TCH to permit standardized postoperative management and emergent retrieval of the balloon in the event of preterm labor or premature rupture of membranes prior to the scheduled removal.
After the FETO surgery, prior to leaving the hospital, the mother will be given a medical alert bracelet identifying her as a patient with a baby with blocked airways. She will be encouraged to wear the bracelet at all times so that in case of emergency, she and others will know who to contact. She will also be given a pamphlet with instructions for medical personnel describing how to remove the balloon in case of an emergency. She should carry it with her at all times.
Balloon retrieval will be planned at between 32+0/7 and 34+6/7 weeks or no longer than 10 wks after placement, at the discretion of the FETO center. The patient will need to commit to remaining in 30 minutes of Texas Children's Hospital Pavilion for Women until the balloon is retrieved. In the event of a patient relocating after having the balloon placed, despite having committed to remain in the area during consent process, she will be asked to return for the removal. Every effort to make arrangements for her to be managed by the nearest center capable of an EXIT procedure or balloon retrieval (San Francisco or Philadelphia) will be made.
After removal of the balloon, patients will have the choice of delivering at Texas Children's Hospital- Women's Pavilion with the CDH managed and repaired at TCH, or returning to their obstetrician for delivery with subsequent repair of the CDH by the pediatric surgeons at their referring facility. Given the severity of the CDH, the baby will need to be delivered in a facility that has the capability of immediate pediatric surgery services.
We will need to monitor the baby at regular intervals (at 6 weeks, 3 months, 6 months, 1 year, and 2 years) after delivery to see how well the baby is breathing and how well the baby is developing. These check- ups may be at Texas Children's Hospital- Women's Pavilion or can be coordinated with other doctors of the participant's choosing.
If the child continues care at another institution, we will attempt to follow up with a review of the child's medical records.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Endotracheal Occlusion | Experimental | Device: Goldballoon Detachable Balloon and delivery microcatheterPlacement and retrieval of the GoldBAL4 or GoldBal2 Detachable balloon using the plug/unplug method, using BALTACCIDBPE100 Delivery Catheter. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient is a pregnant woman between 18 and 45 years of age
- Singleton pregnancy
- Confirmed diagnosis of severe or extremely severe left, right or bilateral CDH of the fetus
- Severe CDH: -Fetal liver herniated into the hemithorax -Lung-head ratio (LHR) is less than or equal to 1.0 calculated between 27+0/7 and 29+6/7 weeks' gestation
- Extremely Severe CDH: -At least 1/3rd of the liver parenchyma herniated into the thoracic cavity -Lung-head ratio (LHR) is < 0.71 calculated between 22+0/7 and 29+6/7 weeks' gestation
Key exclusion criteria (8 listed)
- Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia
- Allergy to latex
- Allergy or previous adverse reaction to a study medication specified in this protocol
- Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor)
- Fetal aneuploidy, known structural genomic variants, other major fetal anomalies, or known syndromic mutation
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 |
|---|---|---|
| Goldballoon Detachable Balloon and delivery microcatheterAlso: GOLDBAL4 or GOLDBAL2 Goldballoon, BALTACCIBDPE100 delivery microcatheterBetween 27+0/7 - 29+ 6/7 weeks gestation for severe CDH and can be as early as 22+0/7 weeks gestational age for those deemed as "extremely severe" cases of CDH, placement of the Goldvalve detachable balloon. Balloon retrieval will be planned for between 32+0/7 and 34+6/7 weeks or no longer than 10 weeks after balloon placement at the discretion of the FETO center. | Device | Fetal Endotracheal Occlusion |
Primary outcome
2-year Survival
Time frame: 2 years after childbirth.
To assess two-year neonatal survival following FETO.
21 secondary outcomes
Successful completion of surgical procedures/balloon placement
Time frame: Up to 10 weeks.
Maternal Outcomes- Maternal Morbidity-incidence of preterm delivery
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity-incidence of cesarean section
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity-length of hospitalization
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- length of hospitalization after UNPLUG procedure
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- vaginal bleeding
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- Placental abruption
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- Rupture of membranes
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- oligohydramnios
Time frame: Up to 6 weeks postpartum
Maternal Outcomes- Maternal Morbidity- chorioamnionitis
Time frame: Up to 6 weeks postpartum
Neonatal/Child outcomes- Pulmonary Morbidity - ECMO
Time frame: Up to 2 years of age
Neonatal/Child outcomes- Pulmonary Morbidity- ventilatory support
Time frame: Up to 2 years of age
Neonatal/Child outcomes- Pulmonary Morbidity- Supplemental oxygen
Time frame: Up to 2 years of age
Neonatal/Child outcomes- gastrointestinal morbidity
Time frame: Up to 2 years of age
Neonatal/Child outcomes-neurologic morbidity
Time frame: Up to 2 years of age
Neonatal/Child outcomes- Survival to discharge from the hospital
Time frame: Up to 2 years of age
Neonatal/Child outcomes- Duration of hospitalization.
Time frame: Up to 2 years of age
Neonatal/Child outcomes- need for supplemental oxygen
Time frame: Up to 18 years of age
Neonatal/Child outcomes- recurrent infection
Time frame: Up to 18 years of age
Neonatal/Child outcomes- repeated hospitalization
Time frame: Up to 18 years of age
Neonatal/Child outcomes- Neurodevelopmental
Time frame: Up to 18 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 16050527Deprest J, Jani J, Gratacos E, Vandecruys H, Naulaers G, Delgado J, Greenough A, Nicolaides K; FETO Task Group. Fetal intervention for congenital diaphragmatic hernia: the European experience. Semin Perinatol. 2005 Apr;29(2):94-103. doi: 10.1053/j.semperi.2005.04.006.
- Background: PubMed 16481263Deprest J, Jani J, Van Schoubroeck D, Cannie M, Gallot D, Dymarkowski S, Fryns JP, Naulaers G, Gratacos E, Nicolaides K. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia. J Pediatr Surg. 2006 Feb;41(2):423-30. doi: 10.1016/j.jpedsurg.2005.11.036.
- Background: PubMed 18634116Done E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033.
- Background: PubMed 18072025Saura L, Castanon M, Prat J, Albert A, Caceres F, Moreno J, Gratacos E. Impact of fetal intervention on postnatal management of congenital diaphragmatic hernia. Eur J Pediatr Surg. 2007 Dec;17(6):404-7. doi: 10.1055/s-2007-989275.
- Background: PubMed 19125386Deprest JA, Hyett JA, Flake AW, Nicolaides K, Gratacos E. Current controversies in prenatal diagnosis 4: Should fetal surgery be done in all cases of severe diaphragmatic hernia? Prenat Diagn. 2009 Jan;29(1):15-9. doi: 10.1002/pd.2108. No abstract available.
- Background: PubMed 16818078Kohl T, Gembruch U, Tchatcheva K, Schaible T. Current consequences of prenatal diagnosis of congenital diaphragmatic hernia by Deprest et al (J Ped Surg 2006;41:423-30). J Pediatr Surg. 2006 Jul;41(7):1344-5; author reply 1345-6. doi: 10.1016/j.jpedsurg.2006.04.001. No abstract available.
- Background: PubMed 8054005Harrison MR, Adzick NS, Estes JM, Howell LJ. A prospective study of the outcome for fetuses with diaphragmatic hernia. JAMA. 1994 Feb 2;271(5):382-4.
- Results publication: PubMed 27926636Belfort MA, Olutoye OO, Cass DL, Olutoye OA, Cassady CI, Mehollin-Ray AR, Shamshirsaz AA, Cruz SM, Lee TC, Mann DG, Espinoza J, Welty SE, Fernandes CJ, Ruano R. Feasibility and Outcomes of Fetoscopic Tracheal Occlusion for Severe Left Diaphragmatic Hernia. Obstet Gynecol. 2017 Jan;129(1):20-29. doi: 10.1097/AOG.0000000000001749.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael Belfort, MD, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goldballoon Detachable Balloon and delivery microcatheter in people with Congenital Diaphragmatic Hernia, run by Michael A Belfort 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
2-year Survival (time frame: 2 years after childbirth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00881660, which also lists 8 linked publications.
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 30 Sep 2026.