Congenital DiseasesPhase 2/3TOTALNCT01240057
Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
A Phase 2/3 study testing fetal endoluminal tracheal occlusion and watchful waiting during pregnancy in people with Congenital Diseases and Diaphragmatic Hernia, run by University Hospital, Gasthuisberg at 12 sites in 11 countries.
Trial summary
This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Congenital Diseases, Diaphragmatic Hernia, Pulmonary Hypoplasia
- What is being tested?
- fetal endoluminal tracheal occlusion and watchful waiting during pregnancy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 12 sitesin 11 countries
- Study dates
- Nov 2011to Dec 2020
- Phase
- Phase 2/3
- 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 50 years
- Women only
- No healthy volunteers
- 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 29 wks plus 5 d (so that occlusion is done at the latest on 29 wks plus 6 d)
- Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR <25 %, irrespective of the liver position
Show all 10Show fewer
- 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
12 sites in 11 countries.
12 sites in 11 countries
Italy2 sites
Ospedale Maggiore Policlinico
Milan, 20122
Ospedale Pediatrico Bambino Gesù
Rome, 00123
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
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 Diaphragma Hernia and Severe Pulmonary Hypoplasia.
This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.
- Being tested
- fetal endoluminal tracheal occlusion, watchful waiting during pregnancy
- Keywords
- Isolated Congenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary Hypoplasia
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Hernia, Diaphragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetal endoluminal tracheal occlusionProcedure or surgery
Also called Balt Goldbal 2 balloon
percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
watchful waiting during pregnancyOther
pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
| Study group | Role | What they receive |
|---|---|---|
| expectant management during pregnancy | Placebo comparator | watchful waiting during pregnancy Receives: Other: watchful waiting during pregnancy |
| fetal endoluminal tracheal occlusion | Experimental | fetoscopic balloon occlusion at 27 to 29+6 weeks of gestation Receives: Procedure: fetal endoluminal tracheal occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at discharge from neonatal intensive care unit
The baby can be discharged either alive (and then it qualifies as "surviving at discharge") or dead. Not discharged babies have not reached the primary endpoint.
Measured: at discharge from neonatal intensive care unit
Secondary outcomes (15)
prenatal increase in lung volume after FETO
volume of lung after occlusion
Measured: prior to balloon removal
grading of oxygen dependency
Measured: born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age
occurrence of pulmonary hypertension
determined by cardiac ultrasound
Measured: within first weeks of life
number of days in Neonatal Intensive Care Unit (NICU)
As long as the baby is in the hospital, it is hospitalized either in NICU or in another, less intensive care unit.
The number of days in NICU is an outcome variable, expressed in days.
Measured: within hospital stay
number of days of ventilatory support
Measured: within NICU stay
presence of periventricular leucomalacia
Measured: 2 months of life
presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher
Measured: within hospital stay
number of days till full enteral feeding
Measured: within first 2 years of life
presence of gastro-esophagal reflux
Measured: at discharge
day of surgery
Measured: within hospital stay
requirement for use of patch for repair
Measured: at the time of postnatal surgery
bronchopulmonary dysplasia
defined as oxygen need for at least 28 days
Measured: with the first 8 weeks
Need for Extracorporeal membrane oxygenation
Measured: during NICU admission
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 posted15 Nov 2010 (estimated)
- Study startNov 2011
- Primary completionMar 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Congenital DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 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, University Hospital, Bonn, Mater Mothers' Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Pediatrico Bambino Gesù, Rome (IT), Mount Sinai Hospital, Canada, National Center for Child Health and Development, Japan, The University of Texas Health Science Center, Houston, Medical University of Warsaw
- Responsible party
- Principal investigator, Jan Deprest, University Hospital, Gasthuisberg
- Investigators
- Jan Deprest, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240057
- Sponsor's protocol ID
- ML 6277
- Other IDs
- B32220108118
- Acronym
- TOTAL
- Status last verified
- May 2021
- First submitted
- 4 Aug 2010
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jani 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 J, Breysem L, Gratacos E, Nicolaides K, Claus F, Debeer A, Smet MH, Proesmans M, Fayoux P, Storme L. Tracheal side effects following fetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Radiol. 2010 May;40(5):670-3. doi: 10.1007/s00247-010-1579-9. Epub 2010 Mar 30. No abstract available.
PubMed 20352401Deprest 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 19125386Deprest JA, Flemmer AW, Gratacos E, Nicolaides K. Antenatal prediction of lung volume and in-utero treatment by fetal endoscopic tracheal occlusion in severe isolated congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2009 Feb;14(1):8-13. doi: 10.1016/j.siny.2008.08.010. Epub 2008 Oct 8.
PubMed 18845492Jani JC, Benachi A, Nicolaides KH, Allegaert K, Gratacos E, Mazkereth R, Matis J, Tibboel D, Van Heijst A, Storme L, Rousseau V, Greenough A, Deprest JA; Antenatal-CDH-Registry group. Prenatal prediction of neonatal morbidity in survivors with congenital diaphragmatic hernia: a multicenter study. Ultrasound Obstet Gynecol. 2009 Jan;33(1):64-9. doi: 10.1002/uog.6141.
PubMed 18844275Jani 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 17587219Jani J, Keller RL, Benachi A, Nicolaides KH, Favre R, Gratacos E, Laudy J, Eisenberg V, Eggink A, Vaast P, Deprest J; Antenatal-CDH-Registry Group. Prenatal prediction of survival in isolated left-sided diaphragmatic hernia. Ultrasound Obstet Gynecol. 2006 Jan;27(1):18-22. doi: 10.1002/uog.2688.
PubMed 16374756Deprest 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 15287047Rodrigues HC, Deprest J, v d Berg PP. When referring physicians and researchers disagree on equipoise: the TOTAL trial experience. Prenat Diagn. 2011 Jun;31(6):589-94. doi: 10.1002/pd.2756. Epub 2011 Apr 11.
PubMed 21484841Deprest J, Flake A. How should fetal surgery for congenital diaphragmatic hernia be implemented in the post-TOTAL trial era: A discussion. Prenat Diagn. 2022 Mar;42(3):301-309. doi: 10.1002/pd.6091. Epub 2022 Jan 22.
PubMed 35032132Van Calster B, Benachi A, Nicolaides KH, Gratacos E, Berg C, Persico N, Gardener GJ, Belfort M, Ville Y, Ryan G, Johnson A, Sago H, Kosinski P, Bagolan P, Van Mieghem T, DeKoninck PLJ, Russo FM, Hooper SB, Deprest JA. The randomized Tracheal Occlusion To Accelerate Lung growth (TOTAL)-trials on fetal surgery for congenital diaphragmatic hernia: reanalysis using pooled data. Am J Obstet Gynecol. 2022 Apr;226(4):560.e1-560.e24. doi: 10.1016/j.ajog.2021.11.1351. Epub 2021 Nov 19.
PubMed 34808130Deprest JA, Nicolaides KH, Benachi A, Gratacos E, Ryan G, Persico N, Sago H, Johnson A, Wielgos M, Berg C, Van Calster B, Russo FM; TOTAL Trial for Severe Hypoplasia Investigators. Randomized Trial of Fetal Surgery for Severe Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):107-118. doi: 10.1056/NEJMoa2027030. Epub 2021 Jun 8.
PubMed 34106556
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. 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 Diaphragma Hernia and Severe Pulmonary Hypoplasia.
- ClinicalTrials.gov ID
- NCT01240057
- Acronym / sponsor ID
- TOTAL / ML 6277
- Keywords
- Isolated Congenital Diaphragmatic Hernia, Fetal Surgery, Pulmonary Hypoplasia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, Hospital Clinic of Barcelona, Hopital Antoine Beclere, University Hospital, Bonn, Mater Mothers' Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Pediatrico Bambino Gesù, Rome (IT), Mount Sinai Hospital, Canada, National Center for Child Health and Development, Japan, The University of Texas Health Science Center, Houston, Medical University of Warsaw
- Study start
- Nov 2011
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 15 Nov 2010 (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.
This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| expectant management during pregnancy | Placebo comparator | Other: watchful waiting during pregnancywatchful waiting during pregnancy |
| fetal endoluminal tracheal occlusion | Experimental | Procedure: fetal endoluminal tracheal occlusionfetoscopic balloon occlusion at 27 to 29+6 weeks of gestation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 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 29 wks plus 5 d (so that occlusion is done at the latest on 29 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 |
|---|---|---|
| fetal endoluminal tracheal occlusionAlso: Balt Goldbal 2 balloonpercutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks | Procedure or surgery | fetal endoluminal tracheal occlusion |
| watchful waiting during pregnancypregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening | Other | expectant management during pregnancy |
Primary outcome
Survival at discharge from neonatal intensive care unit
Time frame: at discharge from neonatal intensive care unit
The baby can be discharged either alive (and then it qualifies as "surviving at discharge") or dead. Not discharged babies have not reached the primary endpoint.
15 secondary outcomes
prenatal increase in lung volume after FETO
Time frame: prior to balloon removal
grading of oxygen dependency
Time frame: born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age
occurrence of pulmonary hypertension
Time frame: within first weeks of life
number of days in Neonatal Intensive Care Unit (NICU)
Time frame: within hospital stay
number of days of ventilatory support
Time frame: within NICU stay
presence of periventricular leucomalacia
Time frame: 2 months of life
presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher
Time frame: within hospital stay
number of days till full enteral feeding
Time frame: within first 2 years of life
presence of gastro-esophagal reflux
Time frame: at discharge
day of surgery
Time frame: within hospital stay
requirement for use of patch for repair
Time frame: at the time of postnatal surgery
bronchopulmonary dysplasia
Time frame: with the first 8 weeks
Need for Extracorporeal membrane oxygenation
Time frame: during NICU admission
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 4 May 2021.
- 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 20352401Deprest J, Breysem L, Gratacos E, Nicolaides K, Claus F, Debeer A, Smet MH, Proesmans M, Fayoux P, Storme L. Tracheal side effects following fetal endoscopic tracheal occlusion for severe congenital diaphragmatic hernia. Pediatr Radiol. 2010 May;40(5):670-3. doi: 10.1007/s00247-010-1579-9. Epub 2010 Mar 30. No abstract available.
- 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 18845492Deprest JA, Flemmer AW, Gratacos E, Nicolaides K. Antenatal prediction of lung volume and in-utero treatment by fetal endoscopic tracheal occlusion in severe isolated congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2009 Feb;14(1):8-13. doi: 10.1016/j.siny.2008.08.010. Epub 2008 Oct 8.
- Background: PubMed 18844275Jani JC, Benachi A, Nicolaides KH, Allegaert K, Gratacos E, Mazkereth R, Matis J, Tibboel D, Van Heijst A, Storme L, Rousseau V, Greenough A, Deprest JA; Antenatal-CDH-Registry group. Prenatal prediction of neonatal morbidity in survivors with congenital diaphragmatic hernia: a multicenter study. Ultrasound Obstet Gynecol. 2009 Jan;33(1):64-9. doi: 10.1002/uog.6141.
- 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 16374756Jani J, Keller RL, Benachi A, Nicolaides KH, Favre R, Gratacos E, Laudy J, Eisenberg V, Eggink A, Vaast P, Deprest J; Antenatal-CDH-Registry Group. Prenatal prediction of survival in isolated left-sided diaphragmatic hernia. Ultrasound Obstet Gynecol. 2006 Jan;27(1):18-22. doi: 10.1002/uog.2688.
- 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 21484841Rodrigues HC, Deprest J, v d Berg PP. When referring physicians and researchers disagree on equipoise: the TOTAL trial experience. Prenat Diagn. 2011 Jun;31(6):589-94. doi: 10.1002/pd.2756. Epub 2011 Apr 11.
- Derived from this study: PubMed 35032132Deprest J, Flake A. How should fetal surgery for congenital diaphragmatic hernia be implemented in the post-TOTAL trial era: A discussion. Prenat Diagn. 2022 Mar;42(3):301-309. doi: 10.1002/pd.6091. Epub 2022 Jan 22.
- Derived from this study: PubMed 34808130Van Calster B, Benachi A, Nicolaides KH, Gratacos E, Berg C, Persico N, Gardener GJ, Belfort M, Ville Y, Ryan G, Johnson A, Sago H, Kosinski P, Bagolan P, Van Mieghem T, DeKoninck PLJ, Russo FM, Hooper SB, Deprest JA. The randomized Tracheal Occlusion To Accelerate Lung growth (TOTAL)-trials on fetal surgery for congenital diaphragmatic hernia: reanalysis using pooled data. Am J Obstet Gynecol. 2022 Apr;226(4):560.e1-560.e24. doi: 10.1016/j.ajog.2021.11.1351. Epub 2021 Nov 19.
- opens only end 2010Link 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 Deprest, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
12 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fetal endoluminal tracheal occlusion and watchful waiting during pregnancy in people with Congenital Diseases and Diaphragmatic Hernia, run by University Hospital, Gasthuisberg at 12 sites in 11 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 10 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, United States, Australia, Belgium, Canada and 6 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from neonatal intensive care unit (time frame: at discharge from neonatal intensive care unit). 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 NCT01240057, which also lists 13 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 4 May 2021.