Congenital Diaphragmatic HerniaNCT06281717
Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
A study testing Fetal Endotracheal Occlusion (FETO) in people with Congenital Diaphragmatic Hernia, run by Eyal Krispin at 1 site in United States.
Trial summary
The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Fetal Endotracheal Occlusion (FETO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 28 Feb 2031
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patient 18 and older who is able to consent
- Singleton pregnancy
- Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal
- Patient has a support person who is able to stay with them for the duration of the pregnancy
- Fetal:
- Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants
Show all 9Show fewer
- Diagnosis of isolated left CDH with liver up
- Gestation at enrollment prior to 29 weeks 5 days
- SEVERE pulmonary hypoplasia with ultrasound Observed/Expected Lung-to-Head Ratio (O/E LHR) < 25%
Who cannot join
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly
- Latex allergy
- Preterm labor, shortened cervix (<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Severe maternal obesity pre-pregnancy (BMI > 40)
- Psychosocial ineligibility, precluding consent, as determined by clinic social worker during review
Show all 13Show fewer
- Inability to remain at FETO site during time period of tracheal occlusion, delivery, and postnatal care
- Right-sided or bilateral, left-sided CDH observed-to-expected lung to head ratio > 25% on ultrasound
- Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram that will significantly worsen prognosis
- History of incompetent cervix with or without cerclage
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Maternal-fetal RH (rhesus) isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy
- Maternal HIV, Hepatitis B, Hepatitis C status positive
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
The goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.
This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.
Read the detailed description
The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital diaphragmatic hernia (CDH). CDH is a condition in which the diaphragm fails to completely close, leaving a gap through which abdominal organs can herniate and slide into and out of the chest. In severe cases, abdominal organs move into the chest and stay there, putting pressure on the heart and lungs and potentially causing the disruption or deformation of these structures. Impaired development of the lungs can often lead to a condition known as pulmonary hypertension, a form of high blood pressure that damages the heart. Pulmonary hypoplasia and pulmonary hypertension can be lethal. Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year.
FETO will be performed with the goal of promoting lung growth and improving neonatal outcomes. FETO is a minimally invasive procedure in which a balloon device is inserted into the trachea of the fetus. The devices involved are the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100). The balloon would be left in place for several weeks and allow the lungs to grow, after which it would be removed, enabling the lungs to mature before birth. Participants will continue to be monitored up until the child reaches 2 years of age in order to assess mental and physical development after FETO.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Fetal Endotracheal Occlusion (FETO)
- Keywords
- Hernias, Diaphragmatic, Congenital, Fetoscopic Endoluminal Tracheal Occlusion, Fetal Endoscopic Tracheal Occlusion, Hernia
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Endotracheal Occlusion (FETO)Device
Also called Fetoscopic Endoluminal Tracheal Occlusion, FETO, Fetal Tracheal Occlusion, BALT GOLDBALLOON: GoldBAL2
The FETO insertion procedure will be performed between gestational age 27 weeks 0 days and 29 weeks and 6 days. The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Endotracheal Occlusion (FETO) | Experimental | Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy. Receives: Device: Fetal Endotracheal Occlusion (FETO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Ballon Placement
Defined as direct visualization of balloon deployment above the carina at the time of FETO procedure
Measured: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Successful Balloon Removal
Removal of the balloon prior to delivery, ideally during 34 weeks gestation
Measured: Prior to delivery, ideally at 34 weeks
Balloon placement operative time
Length of FETO procedure for successful balloon placement
Measured: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Balloon removal operative time
Length of FETO procedure for successful balloon removal
Measured: Prior to delivery, ideally at 34 weeks
Type of FETO release
Emergent or non-emergent FETO release
Measured: Prior to delivery, ideally at 34 weeks
Maternal Complications
Maternal complications include: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Measured: From balloon placement to delivery
Gestational age at delivery
Gestational age at delivery will be recorded
Measured: At delivery
Secondary outcomes (17)
Fetal lung volume
Fetal lung volume will be monitored on ultrasound
Measured: Once per week from balloon placement to removal. This measure will be recorded at earliest gestational age of 27 weeks 0 days, and latest at 34+6/7 weeks' gestation.
Observed-to-Expected Lung to Head Ratio
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal.
Measured: Calculated at balloon removal, ideally at 34 weeks gestation
Infant survival
Survival at discharge from the hospital, or at 6 months of age if still hospitalized
Measured: At hospital discharge or 6 months of age, whichever comes first. Hospital discharge typically occurs at 2-3 months of age
Oxygen dependency
Infant dependency on oxygen as defined by Bancalari 2001
Measured: At time of discharge, on average at 2-3 months of age
Number of infants requiring ECMO (extracorporeal membrane oxygenation)
Use of ECMO support will be documented
Measured: Birth to 6 months
NICU (neonatal intensive care unit) stay
Number of days spent in the neonatal intensive care unit
Measured: From birth until discharge, at an average of 2-3 months of age
Ventilator support
Number of days on ventilator support
Measured: Up to 2 years of age
Presence of periventricular leukomalacia
Incidence of periventricular leukomalacia at <2 months postnatally
Measured: From birth until 2 months of age
Presence of neonatal sepsis
Incidence of neonatal sepsis
Measured: From birth until 1 month of age
Presence of intraventricular hemorrhage
Incidence of intraventricular hemorrhage (grade 0-III)
Measured: Up to 2 years of age
Retinopathy of prematurity
Incidence of retinopathy of prematurity (grade III or higher)
Measured: From birth to 1 month of age
Presence of gastro-esophageal reflux
Incidence of gastro-esophageal reflux
Measured: From birth until 2 years of age
CDH repair type
CDH repair type will be documented as patch or muscle flap
Measured: Postnatal, at time of CDH repair, typically within 2 weeks of birth
Pulmonary function
Pulmonary function by spirometry
Measured: At discharge around 2-3 months and at one year of age
Infant Neurodevelopment
Neurodevelopmental testing of the infant using the Bayley-4
Measured: At 6 months, 12 months, and 24 months of age
Route of delivery
Delivery route will be recorded
Measured: At delivery
Maternal hospitalization
Total days of maternal hospital stay after delivery
Measured: From delivery until discharge, around 2-3 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 posted28 Feb 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion28 Feb 2031 (estimated)
Why it stopped: The investigators are withdrawing this pilot FETO study, and are now working to plan a larger phase III FETO trial. The investigators will be posting details about the new FETO study soon.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyal Krispin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eyal Krispin, Boston Children's Hospital
- Investigators
- Alireza Shamshirsaz, MD, Principal investigator, Director, Maternal Fetal Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281717
- Sponsor's protocol ID
- IRB-P00045047
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Done 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 18634116Deprest 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 16050527Saura 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 19125386Harrison 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 8054005Metkus AP, Filly RA, Stringer MD, Harrison MR, Adzick NS. Sonographic predictors of survival in fetal diaphragmatic hernia. J Pediatr Surg. 1996 Jan;31(1):148-51; discussion 151-2. doi: 10.1016/s0022-3468(96)90338-3.
PubMed 8632269Keller RL, Glidden DV, Paek BW, Goldstein RB, Feldstein VA, Callen PW, Filly RA, Albanese CT. The lung-to-head ratio and fetoscopic temporary tracheal occlusion: prediction of survival in severe left congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2003 Mar;21(3):244-9. doi: 10.1002/uog.44.
PubMed 12666218Albanese CT, Lopoo J, Goldstein RB, Filly RA, Feldstein VA, Calen PW, Jennings RW, Farrell JA, Harrison MR. Fetal liver position and perinatal outcome for congenital diaphragmatic hernia. Prenat Diagn. 1998 Nov;18(11):1138-42. doi: 10.1002/(sici)1097-0223(199811)18:113.0.co;2-a.
PubMed 9854721Stege G, Fenton A, Jaffray B. Nihilism in the 1990s: the true mortality of congenital diaphragmatic hernia. Pediatrics. 2003 Sep;112(3 Pt 1):532-5. doi: 10.1542/peds.112.3.532.
PubMed 12949279Does extracorporeal membrane oxygenation improve survival in neonates with congenital diaphragmatic hernia? The Congenital Diaphragmatic Hernia Study Group. J Pediatr Surg. 1999 May;34(5):720-4; discussion 724-5. doi: 10.1016/s0022-3468(99)90363-9.
PubMed 10359171Cacciari A, Ruggeri G, Mordenti M, Ceccarelli PL, Baccarini E, Pigna A, Gentili A. High-frequency oscillatory ventilation versus conventional mechanical ventilation in congenital diaphragmatic hernia. Eur J Pediatr Surg. 2001 Feb;11(1):3-7. doi: 10.1055/s-2001-12204.
PubMed 11370980Desfrere L, Jarreau PH, Dommergues M, Brunhes A, Hubert P, Nihoul-Fekete C, Mussat P, Moriette G. Impact of delayed repair and elective high-frequency oscillatory ventilation on survival of antenatally diagnosed congenital diaphragmatic hernia: first application of these strategies in the more "severe" subgroup of antenatally diagnosed newborns. Intensive Care Med. 2000 Jul;26(7):934-41. doi: 10.1007/s001340051284.
PubMed 10990109Muratore CS, Kharasch V, Lund DP, Sheils C, Friedman S, Brown C, Utter S, Jaksic T, Wilson JM. Pulmonary morbidity in 100 survivors of congenital diaphragmatic hernia monitored in a multidisciplinary clinic. J Pediatr Surg. 2001 Jan;36(1):133-40. doi: 10.1053/jpsu.2001.20031.
PubMed 11150452Muratore CS, Utter S, Jaksic T, Lund DP, Wilson JM. Nutritional morbidity in survivors of congenital diaphragmatic hernia. J Pediatr Surg. 2001 Aug;36(8):1171-6. doi: 10.1053/jpsu.2001.25746.
PubMed 11479850Boloker J, Bateman DA, Wung JT, Stolar CJ. Congenital diaphragmatic hernia in 120 infants treated consecutively with permissive hypercapnea/spontaneous respiration/elective repair. J Pediatr Surg. 2002 Mar;37(3):357-66. doi: 10.1053/jpsu.2002.30834.
PubMed 11877648
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Role of Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT06281717
- Acronym / sponsor ID
- IRB-P00045047
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- Hernias, Diaphragmatic, Congenital, Fetoscopic Endoluminal Tracheal Occlusion, Fetal Endoscopic Tracheal Occlusion, Hernia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators are withdrawing this pilot FETO study, and are now working to plan a larger phase III FETO trial. The investigators will be posting details about the new FETO study soon.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eyal KrispinUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 28 Feb 2024 (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 goal of this pilot trial is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with severe congenital diaphragmatic hernia (CDH). The research team will investigate the feasibility and safety of the FETO procedure, as well as determine whether FETO can improve lung growth before birth, and survival after birth.
This study will enroll 10 pregnant participants to undergo the FETO procedure at a gestational age of 27 weeks 0 days to 29 weeks 6 days. The participant will be monitored for a few weeks, and then the FETO removal procedure will be performed ideally at 34 weeks 0 days to 34 weeks 6 days, but may be indicated earlier as determined by the Maternal Fetal care team. The pregnant participant and their baby will continue to be monitored during delivery and up until the child reaches 2 years of age.
Detailed description
The goal of this study is to learn more about the role of Fetal Endotracheal Occlusion (FETO) as an intervention in fetuses with isolated severe congenital diaphragmatic hernia (CDH). CDH is a condition in which the diaphragm fails to completely close, leaving a gap through which abdominal organs can herniate and slide into and out of the chest. In severe cases, abdominal organs move into the chest and stay there, putting pressure on the heart and lungs and potentially causing the disruption or deformation of these structures. Impaired development of the lungs can often lead to a condition known as pulmonary hypertension, a form of high blood pressure that damages the heart. Pulmonary hypoplasia and pulmonary hypertension can be lethal. Congenital diaphragmatic hernia (CDH) affects 1 in 2,200 to 5,000 live births per year.
FETO will be performed with the goal of promoting lung growth and improving neonatal outcomes. FETO is a minimally invasive procedure in which a balloon device is inserted into the trachea of the fetus. The devices involved are the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100). The balloon would be left in place for several weeks and allow the lungs to grow, after which it would be removed, enabling the lungs to mature before birth. Participants will continue to be monitored up until the child reaches 2 years of age in order to assess mental and physical development after FETO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fetal Endotracheal Occlusion (FETO) | Experimental | Device: Fetal Endotracheal Occlusion (FETO)Participants with severe congenital diaphragmatic hernia will undergo the FETO therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnant patient 18 and older who is able to consent
- Singleton pregnancy
- Ability to reside within 30 minutes of Boston Children's Hospital for the duration of the FETO intervention, from the time of balloon placement until balloon removal
- Patient has a support person who is able to stay with them for the duration of the pregnancy
- Reassuring genetic analysis demonstrated by either normal Karyotype, normal fluorescence in situ hybridization (FISH) for chromosomes 13, 18, 21, X and Y, or chromosomal microarray (CMA) with non-pathologic variants
Key exclusion criteria (13 listed)
- Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
- Technical limitations precluding fetoscopic surgery, including uterine anomaly such as large or multiple fibroids, or Mullerian duct anomaly
- Latex allergy
- Preterm labor, shortened cervix (<20mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
- Severe maternal obesity pre-pregnancy (BMI > 40)
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 Endotracheal Occlusion (FETO)Also: Fetoscopic Endoluminal Tracheal Occlusion, FETO, Fetal Tracheal Occlusion, BALT GOLDBALLOON: GoldBAL2The FETO insertion procedure will be performed between gestational age 27 weeks 0 days and 29 weeks and 6 days. The Goldballoon Detachable Balloon (GOLDBAL2) will be inserted in the airway of the fetus using the Delivery Microcatheter (BALTACCI-BDPE100). The fetal tracheal balloon will be removed between 34 weeks 0 days and 34 weeks 6 days gestation or earlier as indicated. | Device | Fetal Endotracheal Occlusion (FETO) |
Primary outcome
Successful Ballon Placement
Time frame: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Defined as direct visualization of balloon deployment above the carina at the time of FETO procedure
Successful Balloon Removal
Time frame: Prior to delivery, ideally at 34 weeks
Removal of the balloon prior to delivery, ideally during 34 weeks gestation
Balloon placement operative time
Time frame: Gestational age of 27 weeks 0 days to 29 weeks 6 days
Length of FETO procedure for successful balloon placement
Balloon removal operative time
Time frame: Prior to delivery, ideally at 34 weeks
Length of FETO procedure for successful balloon removal
Type of FETO release
Time frame: Prior to delivery, ideally at 34 weeks
Emergent or non-emergent FETO release
Maternal Complications
Time frame: From balloon placement to delivery
Maternal complications include: preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis
Gestational age at delivery
Time frame: At delivery
Gestational age at delivery will be recorded
17 secondary outcomes
Fetal lung volume
Time frame: Once per week from balloon placement to removal. This measure will be recorded at earliest gestational age of 27 weeks 0 days, and latest at 34+6/7 weeks' gestation.
Observed-to-Expected Lung to Head Ratio
Time frame: Calculated at balloon removal, ideally at 34 weeks gestation
Infant survival
Time frame: At hospital discharge or 6 months of age, whichever comes first. Hospital discharge typically occurs at 2-3 months of age
Oxygen dependency
Time frame: At time of discharge, on average at 2-3 months of age
Number of infants requiring ECMO (extracorporeal membrane oxygenation)
Time frame: Birth to 6 months
NICU (neonatal intensive care unit) stay
Time frame: From birth until discharge, at an average of 2-3 months of age
Ventilator support
Time frame: Up to 2 years of age
Presence of periventricular leukomalacia
Time frame: From birth until 2 months of age
Presence of neonatal sepsis
Time frame: From birth until 1 month of age
Presence of intraventricular hemorrhage
Time frame: Up to 2 years of age
Retinopathy of prematurity
Time frame: From birth to 1 month of age
Presence of gastro-esophageal reflux
Time frame: From birth until 2 years of age
CDH repair type
Time frame: Postnatal, at time of CDH repair, typically within 2 weeks of birth
Pulmonary function
Time frame: At discharge around 2-3 months and at one year of age
Infant Neurodevelopment
Time frame: At 6 months, 12 months, and 24 months of age
Route of delivery
Time frame: At delivery
Maternal hospitalization
Time frame: From delivery until discharge, around 2-3 months of age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- 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 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 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 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.
- Background: PubMed 8632269Metkus AP, Filly RA, Stringer MD, Harrison MR, Adzick NS. Sonographic predictors of survival in fetal diaphragmatic hernia. J Pediatr Surg. 1996 Jan;31(1):148-51; discussion 151-2. doi: 10.1016/s0022-3468(96)90338-3.
- Background: PubMed 12666218Keller RL, Glidden DV, Paek BW, Goldstein RB, Feldstein VA, Callen PW, Filly RA, Albanese CT. The lung-to-head ratio and fetoscopic temporary tracheal occlusion: prediction of survival in severe left congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2003 Mar;21(3):244-9. doi: 10.1002/uog.44.
- Background: PubMed 9854721Albanese CT, Lopoo J, Goldstein RB, Filly RA, Feldstein VA, Calen PW, Jennings RW, Farrell JA, Harrison MR. Fetal liver position and perinatal outcome for congenital diaphragmatic hernia. Prenat Diagn. 1998 Nov;18(11):1138-42. doi: 10.1002/(sici)1097-0223(199811)18:113.0.co;2-a.
- Background: PubMed 12949279Stege G, Fenton A, Jaffray B. Nihilism in the 1990s: the true mortality of congenital diaphragmatic hernia. Pediatrics. 2003 Sep;112(3 Pt 1):532-5. doi: 10.1542/peds.112.3.532.
- Background: PubMed 10359171Does extracorporeal membrane oxygenation improve survival in neonates with congenital diaphragmatic hernia? The Congenital Diaphragmatic Hernia Study Group. J Pediatr Surg. 1999 May;34(5):720-4; discussion 724-5. doi: 10.1016/s0022-3468(99)90363-9.
- Background: PubMed 11370980Cacciari A, Ruggeri G, Mordenti M, Ceccarelli PL, Baccarini E, Pigna A, Gentili A. High-frequency oscillatory ventilation versus conventional mechanical ventilation in congenital diaphragmatic hernia. Eur J Pediatr Surg. 2001 Feb;11(1):3-7. doi: 10.1055/s-2001-12204.
- Background: PubMed 10990109Desfrere L, Jarreau PH, Dommergues M, Brunhes A, Hubert P, Nihoul-Fekete C, Mussat P, Moriette G. Impact of delayed repair and elective high-frequency oscillatory ventilation on survival of antenatally diagnosed congenital diaphragmatic hernia: first application of these strategies in the more "severe" subgroup of antenatally diagnosed newborns. Intensive Care Med. 2000 Jul;26(7):934-41. doi: 10.1007/s001340051284.
- 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. This study is not recruiting at the moment.
Alireza Shamshirsaz, MD principal investigator
Director, Maternal Fetal Care Center
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 Endotracheal Occlusion (FETO) in people with Congenital Diaphragmatic Hernia, run by Eyal Krispin 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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 29 Apr 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 was withdrawn before enrolling participants, so there are no results.
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?
Successful Ballon Placement (time frame: Gestational age of 27 weeks 0 days to 29 weeks 6 days). The study lists 7 primary outcomes in all. 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 NCT06281717, which also lists 56 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 29 Apr 2026.