Hernia Clinical Trial
— TOTALOfficial title:
TOTAL TRIAL: 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
NCT number | NCT02875860 |
Other study ID # | H-39398 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | October 2019 |
Verified date | May 2022 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO) rather than expectant management during pregnancy, followed by standardized postnatal management, increases survival at discharge and decreases oxygen need at 6 months in case of survival till discharge.
Status | Completed |
Enrollment | 5 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: 1. Patients aged 18 years or more, who are able to consent, 2. Singleton pregnancy, 3. Chromosomally normal fetus, 4. Gestation at randomization prior to 31 weeks plus 5 days or so that occlusion is done at the latest on 31 weeks plus 6 days, 5. Fetus is estimated to have moderate pulmonary hypoplasia, defined prenatally as: • 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. The O/E LHR will be determined by the FETO centers as follows: - Measurement of the contralateral lung area preferentially by the tracing method at the 4-chamber view of the heart; if by other method adjusted normative ranges must be used. - Measurement of the head circumference at the standard biparietal view of the head - The observed lung area: calculation of the LHR as the ratio of the measurements of the lung area to head circumference - The expected lung area is the lung area of a normal gestational age match, as determined by the head circumference of the index case in a normogram established for the same measurement method (tracing method in this case). A calculator for this will be available on the website of the study. - Calculation of the observed over expected lung area, 6. Acceptance of randomization and the consequences for the further management during pregnancy and thereafter, this includes the required observation following FETO surgery, which lasts up to 4 weeks after balloon is in place, 7. 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," and 8. Provide written consent to participate. 9. Fetus with no major anomalies that would impact the clinical course or outcomes. Exclusion Criteria: 1. Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risky, 2. Technical limitations precluding fetoscopic surgery, such as severe maternal obesity, uterine fibroids or potentially others, not anticipated at the time of writing this protocol, 3. Preterm labor, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labor, placenta previa, 4. Patient age less than 18 years, 5. Psychosocial ineligibility, precluding consent, 6. Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided outside the O/E LHR limits for the inclusion criteria, and 7. Patient refusing randomization, to comply with required 4-week observation after balloon placement, or to comply with return to FETO center during the time period the airways are occluded or for elective removal of the balloon. 8. Patient allergic to latex. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine/Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Michael A Belfort | Baylor College of Medicine, Universitaire Ziekenhuizen Leuven |
United States,
Cannie MM, Jani JC, De Keyzer F, Allegaert K, Dymarkowski S, Deprest J. Evidence and patterns in lung response after fetal tracheal occlusion: clinical controlled study. Radiology. 2009 Aug;252(2):526-33. doi: 10.1148/radiol.2522081955. Epub 2009 Jun 9. — View Citation
Chiba T, Albanese CT, Farmer DL, Dowd CF, Filly RA, Machin GA, Harrison M. Balloon tracheal occlusion for congenital diaphragmatic hernia: experimental studies. J Pediatr Surg. 2000 Nov;35(11):1566-70. — View Citation
Congenital Diaphragmatic Hernia Study Group, Lally KP, Lally PA, Lasky RE, Tibboel D, Jaksic T, Wilson JM, Frenckner B, Van Meurs KP, Bohn DJ, Davis CF, Hirschl RB. Defect size determines survival in infants with congenital diaphragmatic hernia. Pediatrics. 2007 Sep;120(3):e651-7. — View Citation
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. Erratum in: Ultrasound Obstet Gynecol. 2004 Oct;24(5):594. — View Citation
Deprest JA, Evrard VA, Verbeken EK, Perales AJ, Delaere PR, Lerut TE, Flageole H. Tracheal side effects of endoscopic balloon tracheal occlusion in the fetal lamb model. Eur J Obstet Gynecol Reprod Biol. 2000 Sep;92(1):119-26. — View Citation
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. — View Citation
Gallot D, Boda C, Ughetto S, Perthus I, Robert-Gnansia E, Francannet C, Laurichesse-Delmas H, Jani J, Coste K, Deprest J, Labbe A, Sapin V, Lemery D. Prenatal detection and outcome of congenital diaphragmatic hernia: a French registry-based study. Ultrasound Obstet Gynecol. 2007 Mar;29(3):276-83. — View Citation
Jani J, Benachi A, Mitanchez D, et al. 2006. Lung-to-head ratio and liver position to predict neonatal morbidity in fetuses with isolated congenital diaphragmatic hernia: A multicenter study. Am Journal Obstet Gynecol 195(6); Supplement:S60.
Jani J, Nicolaides K, Gratacos E, et al. 558: Short term neonatal morbidity in severe left-sided congenital diaphragmatic hernia treated by tracheal occlusion before 30 weeks. Am J Obstet Gynecol Dec;197(6),Supplement:S162.
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. — View Citation
Jani JC, Benachi A, Nicolaides KH, Allegaert K, Gratacós 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. — View Citation
Jani JC, Nicolaides KH, Gratacós E, Valencia CM, Doné 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. — View Citation
Jani JC, Nicolaides KH, Gratacós E, Vandecruys H, Deprest JA; FETO Task Group. Fetal lung-to-head ratio in the prediction of survival in severe left-sided diaphragmatic hernia treated by fetal endoscopic tracheal occlusion (FETO). Am J Obstet Gynecol. 2006 Dec;195(6):1646-50. Epub 2006 Jun 12. — View Citation
Ostrea EM, Villanueva-Uy ET, Natarajan G, Uy HG. Persistent pulmonary hypertension of the newborn: pathogenesis, etiology, and management. Paediatr Drugs. 2006;8(3):179-88. Review. — View Citation
Reiss I, Schaible T, van den Hout L, Capolupo I, Allegaert K, van Heijst A, Gorett Silva M, Greenough A, Tibboel D; CDH EURO Consortium. Standardized postnatal management of infants with congenital diaphragmatic hernia in Europe: the CDH EURO Consortium consensus. Neonatology. 2010;98(4):354-64. doi: 10.1159/000320622. Epub 2010 Oct 27. — View Citation
Snoek KG, Capolupo I, van Rosmalen J, Hout Lde J, Vijfhuize S, Greenough A, Wijnen RM, Tibboel D, Reiss IK; CDH EURO Consortium. Conventional Mechanical Ventilation Versus High-frequency Oscillatory Ventilation for Congenital Diaphragmatic Hernia: A Randomized Clinical Trial (The VICI-trial). Ann Surg. 2016 May;263(5):867-74. doi: 10.1097/SLA.0000000000001533. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Neonate Survival at Discharge From Hospital | The null hypothesis to be tested is that there is no difference in survival between fetuses managed expectantly during pregnancy versus those undergoing antenatal therapy (FETO). | At hospital discharge, an average of 1.5 months | |
Primary | Participants Requiring Supplemental Oxygen | The number of survivors requiring supplemental oxygen at 6 months of age | At 6 months of age | |
Secondary | Grade of Oxygen Dependency | Measured as FiO2 (oxygen) amount required as a grade (0-III) with Grade 0 indicating the best outcome and Grade III indicating the worst outcome.
Grade 0 = No Bronchopulmonary Dysplasia (BPD); Grade I = FiO2 21% or room air; Grade II = FiO2 22-29%; Grade III = FiO2 >29%, CPAP or mechanical ventilation. |
at 6 months of age | |
Secondary | Occurrence of Severe Pulmonary Hypertension | Occurrence of severe pulmonary hypertension in the neonatal period. | During the first 4 weeks of life (neonatal period). | |
Secondary | ECMO (Extracorporeal Membrane Oxygenation) Support | Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period | Neonatal period (during the first 4 weeks of life) | |
Secondary | CDH Defect Size | Postnatal grade classification (A-D) using CDH study group standardized system with A being the smallest defects and D being the largest defects.
A = Defect entirely surrounded by muscle; B = Small (<50%) portion of the chest wall devoid of diaphragm tissue; C = Large (>50%) portion of the chest wall devoid of diaphragm tissue; D = Complete or near complete absence of the diaphragm. |
Measured in neonate at delivery by MRI and/or ultrasound | |
Secondary | Number of Days in the NICU | Length of stay in the neonatal intensive care unit measured in days | At the time of discharge from the NICU, an average of 1.5 months | |
Secondary | Ventilatory Support | Length of time participants required ventilator support measured in days. | During the first 4 weeks of life (neonatal period) | |
Secondary | Number of Subjects With Periventricular Leukomalacia (PVL) | As measured by presence in medical record = 2 months postnatally by ultrasound (yes/no) | During first 2 months of life | |
Secondary | Neonatal Sepsis | As measured by presence in medical record | During the first 4 weeks of life (neonatal period) | |
Secondary | Intraventricular Hemorrhage | Measured as presence in neonate during first month by MRI and/or ultrasound. | During first month of life | |
Secondary | Retinopathy of Prematurity | Postnatal grade classification presence of grade III or higher using standardized system (yes/no) | At the time of discharge from the NICU, an average of 1.5 months | |
Secondary | Days to Full Enteral Feeding | The number of days until full enteral feeding | At hospital discharge, an average of 1.5 months | |
Secondary | Gastroesophageal Reflux | Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam | At the time of discharge from the NICU, an average of 1.5 months | |
Secondary | CDH (Congenital Diaphragmatic Hernia) Surgery Repair | How many days from birth until the surgery is performed to repair the defect. | From the time of birth until discharge from the NICU | |
Secondary | Use of Patch in CDH Repair | The number of participants who had a patch used in the repair of the CDH defect. | At the time of the surgical repair postnatally, up to 3 days postnatal | |
Secondary | Survival | The number of participants that survived to 24 months of age | At 24 months of age |
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