HerniaPhase 2TOTALNCT02875860
'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
A Phase 2 study testing GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter and Standardized postnatal care in people with Hernia and Hernia, Diaphragmatic, run by Michael A Belfort at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital
- What is being tested?
- GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter and Standardized postnatal care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 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,
- Chromosomally normal fetus,
- 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,
- 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.
Show all 16Show fewer
- 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,
- 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,
- 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
- Provide written consent to participate.
- Fetus with no major anomalies that would impact the clinical course or outcomes.
Who cannot join
- Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risky,
- 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 labor, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labor, 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, and
- 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.
- Patient allergic to latex.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, 77030
About this study
Official 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
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.
Read the detailed description
This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung development). It essentially compares fetal therapy added to conventional postnatal care, versus expectant prenatal management during pregnancy followed by conventional postnatal care.
Enrollment:
Following completion of an inclusion/exclusion criteria checklist and obtaining informed consent, the subject will be randomized into two groups ("FETO" and "expectant").
Procedures:
Group I: Standardized postnatal care (expectant group): mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.
Group II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.
This study trial is a pragmatical or efficacy trial: ideally mothers will deliver after removal of the balloon at those tertiary centers, typically offering postnatal care for the patient involved. In group II (FETO-group), mothers will, in between placement and removal of the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of our local fetal treatment center (further referred to as FETO center). As many as possible precautions are taken to avoid problems with balloon removal in case of earlier than expected delivery.
- Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24 hours and 7/7 days services for management of fetuses with obstructed airways, either in utero or during labor and delivery.
- Patients in the study and randomized to FETO, will be encouraged to stay near the FETO center. After reversal of the occlusion the patient will be referred to the tertiary care center where delivery and postnatal care will be undertaken. If the patient is not remaining at or close to the FETO center, the postnatal treatment center should organize likewise EXIT services.
- Conditions
- Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical, Congenital Abnormalities, Congenital Diaphragmatic Hernia
- Being tested
- GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter, Standardized postnatal care
- Keywords
- CDH, Congenital Diaphragmatic Hernia, Fetal Tracheal Occlusion, FETO, plug-unplug, GoldBal2, Balloon, Goldvalve Balloon, TOTAL
- Medical subject headings
- Hernia, Hernia, Diaphragmatic, Pathological Conditions, Anatomical, Congenital Abnormalities, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GoldBal2 detachable balloonDevice
Placement of the balloon using the plug/unplug method.
Baltaccidbpe100 Delivery CatheterDevice
The catheter assists with implanting the balloon in the plug/unplug method.
Standardized postnatal careOther
After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622
| Study group | Role | What they receive |
|---|---|---|
| Standardized postnatal care (Expectant) | Other | Mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. Receives: Other: Standardized postnatal care |
| Prenatal Intervention (FETO) | Experimental | Patients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days. Receives: Device: GoldBal2 detachable balloon; Device: Baltaccidbpe100 Delivery Catheter; Other: Standardized postnatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At hospital discharge, an average of 1.5 months
Participants Requiring Supplemental Oxygen
The number of survivors requiring supplemental oxygen at 6 months of age
Measured: At 6 months of age
Secondary outcomes (15)
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.
Measured: at 6 months of age
Occurrence of Severe Pulmonary Hypertension
Occurrence of severe pulmonary hypertension in the neonatal period.
Measured: During the first 4 weeks of life (neonatal period).
ECMO (Extracorporeal Membrane Oxygenation) Support
Need for extracorporeal membrane oxygenation (ECMO) in the neonatal period
Measured: Neonatal period (during the first 4 weeks of life)
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: Measured in neonate at delivery by MRI and/or ultrasound
Number of Days in the NICU
Length of stay in the neonatal intensive care unit measured in days
Measured: At the time of discharge from the NICU, an average of 1.5 months
Ventilatory Support
Length of time participants required ventilator support measured in days.
Measured: During the first 4 weeks of life (neonatal period)
Number of Subjects With Periventricular Leukomalacia (PVL)
As measured by presence in medical record ≤ 2 months postnatally by ultrasound (yes/no)
Measured: During first 2 months of life
Neonatal Sepsis
As measured by presence in medical record
Measured: During the first 4 weeks of life (neonatal period)
Intraventricular Hemorrhage
Measured as presence in neonate during first month by MRI and/or ultrasound.
Measured: During first month of life
Retinopathy of Prematurity
Postnatal grade classification presence of grade III or higher using standardized system (yes/no)
Measured: At the time of discharge from the NICU, an average of 1.5 months
Days to Full Enteral Feeding
The number of days until full enteral feeding
Measured: At hospital discharge, an average of 1.5 months
Gastroesophageal Reflux
Presence of reflux above 1/3 of esophagus on clinically indicated radiologic exam
Measured: At the time of discharge from the NICU, an average of 1.5 months
CDH (Congenital Diaphragmatic Hernia) Surgery Repair
How many days from birth until the surgery is performed to repair the defect.
Measured: From the time of birth until discharge from the NICU
Use of Patch in CDH Repair
The number of participants who had a patch used in the repair of the CDH defect.
Measured: At the time of the surgical repair postnatally, up to 3 days postnatal
Survival
The number of participants that survived to 24 months of age
Measured: At 24 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 posted23 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A Belfort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael A Belfort, Baylor College of Medicine
- Investigators
- Michael Belfort, MD, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875860
- Sponsor's protocol ID
- H-39398
- Acronym
- TOTAL
- Status last verified
- May 2022
- First submitted
- 5 Aug 2016
- Last updated
- 23 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 17587219Jani 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 18844275Deprest 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 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 JC, Nicolaides KH, Gratacos 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. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.
PubMed 16769018Jani 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 19658113Cannie 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.
PubMed 19508989Reiss 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.
PubMed 20980772Snoek 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.
PubMed 26692079Deprest 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 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.
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. doi: 10.2165/00148581-200608030-00004.
PubMed 16774297Congenital 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. doi: 10.1542/peds.2006-3040.
PubMed 17766505Gallot 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. doi: 10.1002/uog.3863.
PubMed 17177265Deprest 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. doi: 10.1016/s0301-2115(00)00435-8.
PubMed 10986445
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02875860
- Acronym / sponsor ID
- TOTAL / H-39398
- Conditions
- Hernia, Hernia, Diaphragmatic, Hernia, DIaphragmatic, Congenital, Pathological Conditions, Anatomical, Congenital Abnormalities, Congenital Diaphragmatic Hernia
- Keywords
- CDH, Congenital Diaphragmatic Hernia, Fetal Tracheal Occlusion, FETO, plug-unplug, GoldBal2, Balloon, Goldvalve Balloon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Michael A BelfortUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, Universitaire Ziekenhuizen KU Leuven
- Study start
- Jan 2017
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 23 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung development). It essentially compares fetal therapy added to conventional postnatal care, versus expectant prenatal management during pregnancy followed by conventional postnatal care.
Enrollment:
Following completion of an inclusion/exclusion criteria checklist and obtaining informed consent, the subject will be randomized into two groups ("FETO" and "expectant").
Procedures:
Group I: Standardized postnatal care (expectant group): mothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website.
Group II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.
This study trial is a pragmatical or efficacy trial: ideally mothers will deliver after removal of the balloon at those tertiary centers, typically offering postnatal care for the patient involved. In group II (FETO-group), mothers will, in between placement and removal of the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of our local fetal treatment center (further referred to as FETO center). As many as possible precautions are taken to avoid problems with balloon removal in case of earlier than expected delivery.
- Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24 hours and 7/7 days services for management of fetuses with obstructed airways, either in utero or during labor and delivery.
- Patients in the study and randomized to FETO, will be encouraged to stay near the FETO center. After reversal of the occlusion the patient will be referred to the tertiary care center where delivery and postnatal care will be undertaken. If the patient is not remaining at or close to the FETO center, the postnatal treatment center should organize likewise EXIT services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized postnatal care (Expectant) | Other | Other: Standardized postnatal careMothers will be expectantly managed during pregnancies and babies receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. |
| Prenatal Intervention (FETO) | Experimental | Device: GoldBal2 detachable balloon, Device: Baltaccidbpe100 Delivery Catheter, Other: Standardized postnatal carePatients will undergo fetoscopic endoluminal tracheal occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal care as in the expectant . In this study FETO (where GoldBal2 detachable balloon and Baltaccidbpe100 Delivery Catheter are used) is to be done between 30 weeks plus 0 day and 31 weeks plus 6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Patients aged 18 years or more, who are able to consent,
- Singleton pregnancy,
- Chromosomally normal fetus,
- 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,
- Fetus is estimated to have moderate pulmonary hypoplasia, defined prenatally as:
Key exclusion criteria (8 listed)
- Maternal contraindication to fetoscopic surgery or severe medical condition in pregnancy that make fetal intervention risky,
- 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 labor, cervix shortened (<15 mm at randomization) or uterine anomaly strongly predisposing to preterm labor, 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 |
|---|---|---|
| GoldBal2 detachable balloonPlacement of the balloon using the plug/unplug method. | Device | Prenatal Intervention (FETO) |
| Baltaccidbpe100 Delivery CatheterThe catheter assists with implanting the balloon in the plug/unplug method. | Device | Prenatal Intervention (FETO) |
| Standardized postnatal careAfter birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622 | Other | Prenatal Intervention (FETO), Standardized postnatal care (Expectant) |
Primary outcome
Proportion of Neonate Survival at Discharge From Hospital
Time frame: At hospital discharge, an average of 1.5 months
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).
Participants Requiring Supplemental Oxygen
Time frame: At 6 months of age
The number of survivors requiring supplemental oxygen at 6 months of age
15 secondary outcomes
Grade of Oxygen Dependency
Time frame: at 6 months of age
Occurrence of Severe Pulmonary Hypertension
Time frame: During the first 4 weeks of life (neonatal period).
ECMO (Extracorporeal Membrane Oxygenation) Support
Time frame: Neonatal period (during the first 4 weeks of life)
CDH Defect Size
Time frame: Measured in neonate at delivery by MRI and/or ultrasound
Number of Days in the NICU
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Ventilatory Support
Time frame: During the first 4 weeks of life (neonatal period)
Number of Subjects With Periventricular Leukomalacia (PVL)
Time frame: During first 2 months of life
Neonatal Sepsis
Time frame: During the first 4 weeks of life (neonatal period)
Intraventricular Hemorrhage
Time frame: During first month of life
Retinopathy of Prematurity
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Days to Full Enteral Feeding
Time frame: At hospital discharge, an average of 1.5 months
Gastroesophageal Reflux
Time frame: At the time of discharge from the NICU, an average of 1.5 months
CDH (Congenital Diaphragmatic Hernia) Surgery Repair
Time frame: From the time of birth until discharge from the NICU
Use of Patch in CDH Repair
Time frame: At the time of the surgical repair postnatally, up to 3 days postnatal
Survival
Time frame: At 24 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 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.
- BackgroundJani 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.
- Background: PubMed 16769018Jani JC, Nicolaides KH, Gratacos 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. doi: 10.1016/j.ajog.2006.04.004. Epub 2006 Jun 12.
- 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 19508989Cannie 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.
- Background: PubMed 20980772Reiss 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.
- Background: PubMed 26692079Snoek 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.
- 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.
- BackgroundJani 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.
- Background: PubMed 16774297Ostrea 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. doi: 10.2165/00148581-200608030-00004.
- Information for the public and healthcare providers.Link provided by the sponsor.
- Information for the public and healthcare providers.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael Belfort, MD, PhD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GoldBal2 detachable balloon, Baltaccidbpe100 Delivery Catheter and Standardized postnatal care in people with Hernia and Hernia, Diaphragmatic, run by Michael A Belfort 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 16 inclusion and 8 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 23 Jun 2022. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Neonate Survival at Discharge From Hospital (time frame: At hospital discharge, an average of 1.5 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 NCT02875860, which also lists 16 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 23 Jun 2022.