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| ID | Type | Description | Link |
|---|---|---|---|
| B32220108118 | Other Identifier | UZ Gasthuisberg KU Leuven (Belgium) |
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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Hopital Antoine Beclere | OTHER |
| University Hospital, Bonn |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| expectant management during pregnancy | Placebo Comparator | watchful waiting during pregnancy |
|
| fetal endoluminal tracheal occlusion | Experimental | fetoscopic balloon occlusion at 27 to 29+6 weeks of gestation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fetal endoluminal tracheal occlusion | Procedure | percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at discharge from neonatal intensive care unit |
| Measure | Description | Time Frame |
|---|---|---|
| prenatal increase in lung volume after FETO | volume of lung after occlusion | prior to balloon removal |
| grading of oxygen dependency | born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Deprest, MD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77030 | United States | ||
| Mater Mother's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19658113 | Background | 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. | |
| 20352401 | Background | Deprest 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. |
| Label | URL |
|---|---|
| opens only end 2010 | View source |
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| OTHER |
| Mater Mothers' Hospital | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| Ospedale Pediatrico Bambino Gesù, Rome (IT) | UNKNOWN |
| Mount Sinai Hospital, Canada | OTHER |
| National Center for Child Health and Development, Japan | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Medical University of Warsaw | OTHER |
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|
| watchful waiting during pregnancy | Other | pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening |
|
| occurrence of pulmonary hypertension | determined by cardiac ultrasound | 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. | within hospital stay |
| number of days of ventilatory support | within NICU stay |
| presence of periventricular leucomalacia | 2 months of life |
| presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher | within hospital stay |
| number of days till full enteral feeding | within first 2 years of life |
| presence of gastro-esophagal reflux | at discharge |
| day of surgery | within hospital stay |
| requirement for use of patch for repair | at the time of postnatal surgery |
| bronchopulmonary dysplasia | defined as oxygen need for at least 28 days | with the first 8 weeks |
| Need for Extracorporeal membrane oxygenation | during NICU admission |
| Defect size | at the time of postnatal surgery |
| number of days alive in case of postnatal death | during NICU admission |
| Brisbane |
| Queensland |
| 4101 |
| Australia |
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Hôpital Antoine Béclère | Clamart | 92141 | France |
| University Hospital of Bonn | Bonn | 53105 | Germany |
| Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Ospedale Pediatrico Bambino Gesù | Rome | 00123 | Italy |
| National Center for Child Health and Development | Tokyo | 157-8535 | Japan |
| 1st Department of Obstetrics and Gynecology, Medical University of Warsaw | Warsaw | Poland |
| Hospital Clinic Barcelona | Barcelona | Catalonia | 08028 | Spain |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| 19559323 | Background | Deprest 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. |
| 19125386 | Background | Deprest 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. |
| 18845492 | Background | Deprest 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. |
| 18844275 | Background | Jani 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. |
| 17587219 | Background | 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. |
| 16374756 | Background | Jani 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. |
| 15287047 | Background | Deprest 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. |
| 21484841 | Background | Rodrigues 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. |
| 35032132 | Derived | Deprest 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. |
| 34808130 | Derived | Van 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. |
| 34106556 | Derived | Deprest 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. |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| ID | Term |
|---|---|
| D000082122 | Internal Hernia |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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