ClinicalTrials.gov
ClinicalTrials.gov Menu

Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia (TOTAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240057
Recruitment Status : Recruiting
First Posted : November 15, 2010
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
King's College Hospital NHS Trust (UK)
Hospital Clinic of Barcelona
Hopital Antoine Beclere
Hôpital Necker-Enfants Malades
University Hospital, Bonn
Mater Mother's Hospital, Brisbane (AUS)
Ospedale Maggiore Policlinico, Milan (IT)
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Mount Sinai Hospital, Canada
National Center for Child Health and Development, Tokyo (JP)
University of Texas Health Science Center at Houston, TX (US)
Information provided by (Responsible Party):
Jan Deprest, University Hospital, Gasthuisberg

Brief 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.

Condition or disease Intervention/treatment Phase
Congenital Diseases Diaphragmatic Hernia Pulmonary Hypoplasia Procedure: fetal endoluminal tracheal occlusion Other: watchful waiting during pregnancy Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : November 2011
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Placebo Comparator: expectant management during pregnancy
watchful waiting during pregnancy
Other: watchful waiting during pregnancy
pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening

Experimental: fetal endoluminal tracheal occlusion
fetoscopic balloon occlusion at 27 to 30 weeks of gestation
Procedure: fetal endoluminal tracheal occlusion
percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
Other Name: Balt Goldbal 2 balloon




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. prenatal increase in lung volume [ Time Frame: 2 weeks ]
    volume of lung after occlusion

  2. grading of oxygen dependency [ Time Frame: 56 days of life ]
  3. occurrence of pulmonary hypertension [ Time Frame: within first weeks of life ]
    determined by cardiac ultrasound

  4. number of days in Neonatal Intensive Care Unit (NICU) [ Time Frame: within hospital stay ]

    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.


  5. number of days on ventilator [ Time Frame: within NICU stay ]
  6. presence of periventricular leucomalacia [ Time Frame: 2 months of life ]
  7. presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher [ Time Frame: within hospital stay ]
  8. number of days till full enteral feeding [ Time Frame: within first 2 years of life ]
  9. presence of gastro-esophagal reflux [ Time Frame: at discharge ]
  10. day of surgery [ Time Frame: within hospital stay ]
  11. requirement for use of patch for repair [ Time Frame: at the time of surgery ]
  12. neurodevelopment at 12 and 24 months [ Time Frame: 24 months ]
  13. pulmonary function at one year of age [ Time Frame: one year of age ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240057


Contacts
Contact: Jan A Deprest, MD +3216344215 Jan.Deprest@uzleuven.be
Contact: Leen Mortier +32 16 34 42 15 leen.mortier@uzleuven.be

Locations
United States, Texas
University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Anthony Johnson, MD, PhD       Anthony.Johnson@uth.tmc.edu   
Australia, Queensland
Mater Mother's Hospital Recruiting
Brisbane, Queensland, Australia, 4101
Contact: Glenn Gardener, MD, PhD       glenn.gardener@mater.org.au   
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jan A Deprest, MD PhD    +3216344215    Jan.Deprest@uzleuven.be   
Contact: Leen Mortier    +321644215    leen.mortier@uzleuven.be   
Principal Investigator: Jan A Deprest, MD PhD         
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Greg Ryan, MD, PhD       gryan@mtsinai.on.ca   
France
Hôpital Antoine Béclère Recruiting
Clamart, France, 92141
Contact: Alexandra Benachi, MD, PhD       alexandra.benachi@aphp.fr   
Hôpital Necker - Enfants Malades Recruiting
Paris, France, 75743
Contact: Yves Ville, MD, PhD       yves.ville@nck.aphp.fr   
Germany
University Hospital of Bonn Recruiting
Bonn, Germany, 53105
Contact       christoph.berg@ukb.uni-bonn.de   
Italy
Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
Contact: Nicola Persico, MD, PhD       nicola.persico@gmail.com   
Ospedale Pediatrico Bambino Gesù Recruiting
Rome, Italy, 00123
Contact: Pietro Bagolan, MD, PhD       pietro.bagolan@opbg.net   
Japan
National Center for Child Health and Development Recruiting
Tokyo, Japan, 157-8535
Contact: Haruhiko Sago, MD, PhD       sagou-h@ncchd.go.jp   
Spain
Hospital Clinic Barcelona Recruiting
Barcelona, Catalunya, Spain, 08028
Contact: Eduardo Gratacos, MD PhD    +34 (93) 227 99 46    egratacos@clinic.ub.es   
Principal Investigator: Eduardo Gratacos, MD PhD         
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact       kypros@fetalmedicine.com   
Sponsors and Collaborators
University Hospital, Gasthuisberg
King's College Hospital NHS Trust (UK)
Hospital Clinic of Barcelona
Hopital Antoine Beclere
Hôpital Necker-Enfants Malades
University Hospital, Bonn
Mater Mother's Hospital, Brisbane (AUS)
Ospedale Maggiore Policlinico, Milan (IT)
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Mount Sinai Hospital, Canada
National Center for Child Health and Development, Tokyo (JP)
University of Texas Health Science Center at Houston, TX (US)
Investigators
Principal Investigator: Jan Deprest, MD Universitaire Ziekenhuizen Leuven

Additional Information:
Publications:

Responsible Party: Jan Deprest, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01240057     History of Changes
Other Study ID Numbers: ML 6277
B32220108118 ( Other Identifier: UZ Gasthuisberg KU Leuven (Belgium) )
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Jan Deprest, University Hospital, Gasthuisberg:
Isolated Congenital Diaphragmatic Hernia
Fetal Surgery
Pulmonary Hypoplasia

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities