Congenital Diaphragmatic HerniaTOTAL moderateNCT00763737
Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.
A study testing Fetoscopic Endoluminal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Fetal Surgery, run by University Hospital, Gasthuisberg at 13 sites in 10 countries.
Trial summary
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary Hypoplasia
- What is being tested?
- Fetoscopic Endoluminal Tracheal Occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 13 sitesin 10 countries
- Study dates
- Aug 2010to Mar 2020
- 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
- Patients aged 18 years or more, who are able to consent
- Singleton pregnancy
- Anatomically and chromosomally normal fetus
- Left sided diaphragmatic hernia
- Gestation at randomization prior to 31 wks plus 5 d (so that occlusion is done at the latest on 31 wks plus 6 d)
- Estimated to have moderate pulmonary hypoplasia, defined prenatally as:
Show all 12Show fewer
- O/E LHR 25-34.9% (included; irrespective of the position of the liver)
- O/E LHR 35-44.9% (included) with intrathoracic liver herniation as determined by ultrasound or MRI
- Acceptance of randomization and the consequences for the further management during pregnancy and thereafter.
- The patients must undertake the responsibility for either remaining close to, or at the FETO center, or being able to travel swiftly and within acceptable time interval to the FETO center until the balloon is removed.
- Intended postnatal treatment center must subscribe to suggested guidelines for "standardized postnatal treatment".
- Provide written consent to participate in this RCT
Who cannot join
- Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
- Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
- Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
- Patient age less than 18 years
- Psychosocial ineligibility, precluding consent
- Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria
- Patient refusing randomization or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon
Trial locations and contacts
13 sites in 10 countries.
13 sites in 10 countries
United States2 sites
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
University of Texas Health Science Center
Houston, Texas, 77030
France2 sites
Hôpital Antoine Béclère
Clamart, 92141
Hôpital Necker - Enfants Malades
Paris, 75743
Italy2 sites
Ospedale Maggiore Policlinico
Milan, 20122
Ospedale Pediatrico Bambino Gesù
Rome, 00123
Poland1 site
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Warsaw
About this study
Official title: Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases. The risk for these can be predicted prenatally by the ultrasonographic measurement of the observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of pulmonary hypoplasia. Also position of the liver is predictive of outcome.
The proposing consortium has developed a prenatal therapeutic approach, which consists of percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the balloon. Both procedures are performed percutaneously, there is now experience with more than 150 cases and it has been shown to be safe for the mother. We have witnessed an improvement of survival in fetuses with a predicted chance of survival of less than 30% (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation) to 55% on average. Also there is an apparent reduction in morbidity with the rate of bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than 40% in the same severity group.
Read more
Further we have shown that results of FETO are predicted by LHR measurement prior to the procedure, so that better results can be expected in fetuses with larger lung size. Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%, irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation of the liver). When managed expectantly the estimated rate of postnatal survival is 55%.
This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant management during pregnancy, both followed by standardized postnatal management increases survival or decrease oxygen dependency at 6 months of age. The balloon will be placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.
- Being tested
- Fetoscopic Endoluminal Tracheal Occlusion
- Keywords
- congenital diaphragmatic hernia, fetal surgery, pulmonary hypoplasia, observed/expected lung to head ratio, liver position, feto, fetoscopic endoluminal tracheal occlusion, standardized neonatal 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 OcclusionProcedure or surgery
prenatal balloon placement at 30-31+6 weeks and removal at 34-34+6 wks
| Study group | Role | What they receive |
|---|---|---|
| FETO | Experimental | prenatal FETO at 30-31+6 weeks and removal at 34-34+6 wks, followed by standardized postnatal care Receives: Procedure: Fetoscopic Endoluminal Tracheal Occlusion |
| Expectant management | No intervention | expectant management during pregnancy followed by standardized neonatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at discharge
Measured: at the time of discharge from NICU, approximately 2 months
Supplemental oxygen at 6 months of age
Measured: at 6 months of age
Secondary outcomes (16)
Grading of oxygen dependency
Measured: between 28 and 56 days of life if born >32 weeks; at 36 weeks postmenstrual age if born <32 weeks
Pulmonary hypertension
Measured: during NICU admission
Use of extracorporeal membrane oxygenation
Measured: during NICU admission
Change in O/E LHR after FETO
Measured: prior to unplug
NICU days
Measured: during NICU admission
days of ventilatory support
Measured: during NICU admission
Periventricular leucomalacia
Measured: during NICU admission
Neonatal sepsis
Measured: during NICU admission
Intraventricular hemorrhage
Measured: during NICU admission
Retinopathy of prematurity
Measured: during NICU admission
Days until full enteral feeding
Measured: during NICU admission
Gastroesophageal reflux
Measured: during NICU admission
Day of postnatal surgery
Measured: during NICU admission
Use of patch
Measured: at the time of postnatal surgery
Defect size
Measured: at the time of postnatal surgery
Number of days alive in case of postnatal death
Measured: during NICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startAug 2010
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Hospital Clinic of Barcelona, Hopital Antoine Beclere, Hôpital Necker-Enfants Malades, University Hospital, Bonn, Mater Mothers' Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Pediatrico Bambino Gesù, Rome (IT), Mount Sinai Hospital, Canada, Baylor College of Medicine, The University of Texas Health Science Center, Houston, Medical University of Warsaw
- Responsible party
- Principal investigator, Jan Deprest, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan A Deprest, MD PhD, Study chair, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763737
- Sponsor's protocol ID
- B32220084540
- Other IDs
- 2008-4634, ML4999- B32220084540
- Acronym
- TOTAL moderate
- Status last verified
- Nov 2020
- First submitted
- 30 Sep 2008
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jani J, Nicolaides KH, Keller RL, Benachi A, Peralta CF, Favre R, Moreno O, Tibboel D, Lipitz S, Eggink A, Vaast P, Allegaert K, Harrison M, Deprest J; Antenatal-CDH-Registry Group. Observed to expected lung area to head circumference ratio in the prediction of survival in fetuses with isolated diaphragmatic hernia. Ultrasound Obstet Gynecol. 2007 Jul;30(1):67-71. doi: 10.1002/uog.4052.
PubMed 17587219Done 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 16050527Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. doi: 10.1002/uog.1711.
PubMed 15287047Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
PubMed 19658113Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004.
PubMed 19559323Deprest 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 19125386Gregoir C, Engels AC, Gomez O, DeKoninck P, Lewi L, Gratacos E, Deprest JA. Fertility, pregnancy and gynecological outcomes after fetoscopic surgery for congenital diaphragmatic hernia. Hum Reprod. 2016 Sep;31(9):2024-30. doi: 10.1093/humrep/dew160. Epub 2016 Jul 4.
PubMed 27378767Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.
PubMed 27077664Nawapun K, Eastwood MP, Diaz-Cobos D, Jimenez J, Aertsen M, Gomez O, Claus F, Gratacos E, Deprest J. In vivo evidence by magnetic resonance volumetry of a gestational age dependent response to tracheal occlusion for congenital diaphragmatic hernia. Prenat Diagn. 2015 Nov;35(11):1048-56. doi: 10.1002/pd.4642. Epub 2015 Sep 29.
PubMed 26135752Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
PubMed 25447987Done E, Debeer A, Gucciardo L, Van Mieghem T, Lewi P, Devlieger R, De Catte L, Lewi L, Allegaert K, Deprest J. Prediction of neonatal respiratory function and pulmonary hypertension in fetuses with isolated congenital diaphragmatic hernia in the fetal endoscopic tracleal occlusion era: a single-center study. Fetal Diagn Ther. 2015;37(1):24-32. doi: 10.1159/000364805. Epub 2014 Nov 8.
PubMed 25402437DeKoninck P, Gomez O, Sandaite I, Richter J, Nawapun K, Eerdekens A, Ramirez JC, Claus F, Gratacos E, Deprest J. Right-sided congenital diaphragmatic hernia in a decade of fetal surgery. BJOG. 2015 Jun;122(7):940-6. doi: 10.1111/1471-0528.13065. Epub 2014 Sep 17.
PubMed 25227954Windrim R, Ryan G, Lebouthillier F, Campisi P, Kelly EN, Baud D, Yoo SJ, Deprest J. Development and use of a high-fidelity simulator for fetal endotracheal balloon occlusion (FETO) insertion and removal. Prenat Diagn. 2014 Feb;34(2):180-4. doi: 10.1002/pd.4284. Epub 2013 Dec 27.
PubMed 24284906Engels AC, DeKoninck P, van der Merwe JL, Van Mieghem T, Stevens P, Power B, Nicolaides KH, Gratacos E, Deprest JA. Does website-based information add any value in counseling mothers expecting a baby with severe congenital diaphragmatic hernia? Prenat Diagn. 2013 Nov;33(11):1027-32. doi: 10.1002/pd.4190. Epub 2013 Aug 29.
PubMed 23813901
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.
- ClinicalTrials.gov ID
- NCT00763737
- Acronym / sponsor ID
- TOTAL moderate / B32220084540
- Keywords
- congenital diaphragmatic hernia, fetal surgery, pulmonary hypoplasia, observed/expected lung to head ratio, liver position, feto, fetoscopic endoluminal tracheal occlusion, standardized neonatal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Hospital Clinic of Barcelona, Hopital Antoine Beclere, Hôpital Necker-Enfants Malades, University Hospital, Bonn, Mater Mothers' Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Pediatrico Bambino Gesù, Rome (IT), Mount Sinai Hospital, Canada, Baylor College of Medicine, The University of Texas Health Science Center, Houston, Medical University of Warsaw
- Study start
- Aug 2010
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 1 Oct 2008 (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.
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases. The risk for these can be predicted prenatally by the ultrasonographic measurement of the observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of pulmonary hypoplasia. Also position of the liver is predictive of outcome.
The proposing consortium has developed a prenatal therapeutic approach, which consists of percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the balloon. Both procedures are performed percutaneously, there is now experience with more than 150 cases and it has been shown to be safe for the mother. We have witnessed an improvement of survival in fetuses with a predicted chance of survival of less than 30% (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation) to 55% on average. Also there is an apparent reduction in morbidity with the rate of bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than 40% in the same severity group.
Further we have shown that results of FETO are predicted by LHR measurement prior to the procedure, so that better results can be expected in fetuses with larger lung size. Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%, irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation of the liver). When managed expectantly the estimated rate of postnatal survival is 55%.
This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant management during pregnancy, both followed by standardized postnatal management increases survival or decrease oxygen dependency at 6 months of age. The balloon will be placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FETO | Experimental | Procedure: Fetoscopic Endoluminal Tracheal Occlusionprenatal FETO at 30-31+6 weeks and removal at 34-34+6 wks, followed by standardized postnatal care |
| Expectant management | No intervention | –expectant management during pregnancy followed by standardized neonatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged 18 years or more, who are able to consent
- Singleton pregnancy
- Anatomically and chromosomally normal fetus
- Left sided diaphragmatic hernia
- Gestation at randomization prior to 31 wks plus 5 d (so that occlusion is done at the latest on 31 wks plus 6 d)
Key exclusion criteria (7 listed)
- Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risk full
- Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol.
- Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labour, placenta previa
- Patient age less than 18 years
- Psychosocial ineligibility, precluding consent
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 Occlusionprenatal balloon placement at 30-31+6 weeks and removal at 34-34+6 wks | Procedure or surgery | FETO |
Primary outcome
Survival at discharge
Time frame: at the time of discharge from NICU, approximately 2 months
Supplemental oxygen at 6 months of age
Time frame: at 6 months of age
16 secondary outcomes
Grading of oxygen dependency
Time frame: between 28 and 56 days of life if born >32 weeks; at 36 weeks postmenstrual age if born <32 weeks
Pulmonary hypertension
Time frame: during NICU admission
Use of extracorporeal membrane oxygenation
Time frame: during NICU admission
Change in O/E LHR after FETO
Time frame: prior to unplug
NICU days
Time frame: during NICU admission
days of ventilatory support
Time frame: during NICU admission
Periventricular leucomalacia
Time frame: during NICU admission
Neonatal sepsis
Time frame: during NICU admission
Intraventricular hemorrhage
Time frame: during NICU admission
Retinopathy of prematurity
Time frame: during NICU admission
Days until full enteral feeding
Time frame: during NICU admission
Gastroesophageal reflux
Time frame: during NICU admission
Day of postnatal surgery
Time frame: during NICU admission
Use of patch
Time frame: at the time of postnatal surgery
Defect size
Time frame: at the time of postnatal surgery
Number of days alive in case of postnatal death
Time frame: during NICU admission
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 3 Dec 2020.
- Background: PubMed 17587219Jani J, Nicolaides KH, Keller RL, Benachi A, Peralta CF, Favre R, Moreno O, Tibboel D, Lipitz S, Eggink A, Vaast P, Allegaert K, Harrison M, Deprest J; Antenatal-CDH-Registry Group. Observed to expected lung area to head circumference ratio in the prediction of survival in fetuses with isolated diaphragmatic hernia. Ultrasound Obstet Gynecol. 2007 Jul;30(1):67-71. doi: 10.1002/uog.4052.
- 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 15287047Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. doi: 10.1002/uog.1711.
- Background: PubMed 19658113Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.
- Background: PubMed 19559323Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004.
- 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 27378767Gregoir C, Engels AC, Gomez O, DeKoninck P, Lewi L, Gratacos E, Deprest JA. Fertility, pregnancy and gynecological outcomes after fetoscopic surgery for congenital diaphragmatic hernia. Hum Reprod. 2016 Sep;31(9):2024-30. doi: 10.1093/humrep/dew160. Epub 2016 Jul 4.
- Background: PubMed 27077664Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.
- Background: PubMed 26135752Nawapun K, Eastwood MP, Diaz-Cobos D, Jimenez J, Aertsen M, Gomez O, Claus F, Gratacos E, Deprest J. In vivo evidence by magnetic resonance volumetry of a gestational age dependent response to tracheal occlusion for congenital diaphragmatic hernia. Prenat Diagn. 2015 Nov;35(11):1048-56. doi: 10.1002/pd.4642. Epub 2015 Sep 29.
- Background: PubMed 25447987Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11.
- Background: PubMed 25402437Done E, Debeer A, Gucciardo L, Van Mieghem T, Lewi P, Devlieger R, De Catte L, Lewi L, Allegaert K, Deprest J. Prediction of neonatal respiratory function and pulmonary hypertension in fetuses with isolated congenital diaphragmatic hernia in the fetal endoscopic tracleal occlusion era: a single-center study. Fetal Diagn Ther. 2015;37(1):24-32. doi: 10.1159/000364805. Epub 2014 Nov 8.
- website on prenatal diagnosis and management of CDH of the FETO consortiumLink provided by the sponsor.
- website of this trial on prenatal management of CDHLink provided by the sponsor.
- same as www.euroCDH.orgLink provided by the sponsor.
- same as totaltrial.euLink provided by the sponsor.
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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.
Jan A Deprest, MD PhD study chair
Universitaire Ziekenhuizen KU Leuven
13 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetoscopic Endoluminal Tracheal Occlusion in people with Congenital Diaphragmatic Hernia and Fetal Surgery, run by University Hospital, Gasthuisberg at 13 sites in 10 countries.
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 12 inclusion and 7 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, France, Italy, Australia, Belgium and 5 more countries. 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?
Survival at discharge (time frame: at the time of discharge from NICU, approximately 2 months). 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?
On the ClinicalTrials.gov record for NCT00763737, which also lists 19 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 3 Dec 2020.