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. Read our disclaimer for details. Identifier: NCT01240057
Recruitment Status : Unknown
Verified August 2011 by University Hospital, Gasthuisberg.
Recruitment status was:  Recruiting
First Posted : November 15, 2010
Last Update Posted : August 5, 2011
Information provided by:
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 : 148 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 : December 2010
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2017

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 Nenoatal 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 ]

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

Inclusion Criteria:

  • Consenting subjects
  • fetus with isolated left-sided Congenital Diaphragmatic Hernia (CDH) and
  • severe pulmonary hypoplasia defined as O/E LHR <25 % irrespective of the liver position as measured prior to 29 wks + 6 days at the FETO center

Exclusion Criteria:

  • Maternal contraindication to fetal intervention
  • technical or maternal limitation to fetoscopy
  • preterm labour or cervix<15 mm
  • refusal to return to FETO center during time period airways are occluded

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 identifier (NCT number): NCT01240057

Contact: Jan A Deprest, MD +3216344215
Contact: Philip DeKoninck, MD +3216341926

University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jan A Deprest, MD PhD    +3216344215   
Contact: Philip DeKoninck, MD    +3216341926   
Principal Investigator: Jan A Deprest, MD PhD         
Hospital Clinic Barcelona Recruiting
Barcelona, Catalunya, Spain, 08028
Contact: Eduardo Gratacos, MD PhD    +34 (93) 227 99 46   
Principal Investigator: Eduardo Gratacos, MD PhD         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Principal Investigator: Jan Deprest, MD Universitaire Ziekenhuizen Leuven

Additional Information:

Responsible Party: Jan Deprest, MD PhD, University Hospital, Gasthuisberg 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: August 5, 2011
Last Verified: August 2011

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

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