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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University Hospital, Gasthuisberg
Sponsor:
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01240057
First received: August 4, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Survival at discharge from neonatal intensive care unit [ Time Frame: at discharge from neonatal intensive care unit ] [ Designated as safety issue: No ]
    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:
  • prenatal increase in lung volume [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    volume of lung after occlusion

  • grading of oxygen dependency [ Time Frame: 56 days of life ] [ Designated as safety issue: No ]
  • occurrence of pulmonary hypertension [ Time Frame: within first weeks of life ] [ Designated as safety issue: No ]
    determined by cardiac ultrasound

  • number of days in Nenoatal Intensive Care Unit (NICU) [ Time Frame: within hospital stay ] [ Designated as safety issue: No ]

    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.


  • number of days on ventilator [ Time Frame: within NICU stay ] [ Designated as safety issue: No ]
  • presence of periventricular leucomalacia [ Time Frame: 2 months of life ] [ Designated as safety issue: No ]
  • presence of neonatal sepsis, intraventricular haemorrhage,retinopathy grade III or higher [ Time Frame: within hospital stay ] [ Designated as safety issue: Yes ]
  • number of days till full enteral feeding [ Time Frame: within first 2 years of life ] [ Designated as safety issue: No ]
  • presence of gastro-esophagal reflux [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • day of surgery [ Time Frame: within hospital stay ] [ Designated as safety issue: No ]
  • requirement for use of patch for repair [ Time Frame: at the time of surgery ] [ Designated as safety issue: No ]
  • neurodevelopment at 12 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • pulmonary function at one year of age [ Time Frame: one year of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: December 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240057

Contacts
Contact: Jan A Deprest, MD +3216344215 Jan.Deprest@uzleuven.be
Contact: Philip DeKoninck, MD +3216341926 Philip.Dekoninck@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Jan A Deprest, MD PhD    +3216344215    Jan.Deprest@uzleuven.be   
Contact: Philip DeKoninck, MD    +3216341926    philip.dekoninck@uzleuven.be   
Principal Investigator: Jan A Deprest, MD PhD         
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         
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Jan Deprest, MD Universitaire Ziekenhuizen Leuven
  More Information

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
Study First Received: August 4, 2010
Last Updated: August 4, 2011
Health Authority: Belgium: Institutional Review Board

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

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 14, 2014