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

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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

Tracking Information
First Submitted Date  ICMJE August 4, 2010
First Posted Date  ICMJE November 15, 2010
Last Update Posted Date May 30, 2018
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
Survival at discharge from neonatal intensive care unit [ Time Frame: at discharge from neonatal intensive care unit ]
Change History Complete list of historical versions of study NCT01240057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
  • prenatal increase in lung volume [ Time Frame: 2 weeks ]
    volume of lung after occlusion
  • grading of oxygen dependency [ Time Frame: 56 days of life ]
  • occurrence of pulmonary hypertension [ Time Frame: within first weeks of life ]
    determined by cardiac ultrasound
  • 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.
  • number of days on ventilator [ Time Frame: within NICU stay ]
  • presence of periventricular leucomalacia [ Time Frame: 2 months of life ]
  • presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher [ Time Frame: within hospital stay ]
  • number of days till full enteral feeding [ Time Frame: within first 2 years of life ]
  • presence of gastro-esophagal reflux [ Time Frame: at discharge ]
  • day of surgery [ Time Frame: within hospital stay ]
  • requirement for use of patch for repair [ Time Frame: at the time of surgery ]
  • neurodevelopment at 12 and 24 months [ Time Frame: 24 months ]
  • pulmonary function at one year of age [ Time Frame: one year of age ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
  • prenatal increase in lung volume [ Time Frame: 2 weeks ]
    volume of lung after occlusion
  • grading of oxygen dependency [ Time Frame: 56 days of life ]
  • occurrence of pulmonary hypertension [ Time Frame: within first weeks of life ]
    determined by cardiac ultrasound
  • number of days in Nenoatal Intensive Care Unit (NICU) [ Time Frame: within hospital stay ]
  • number of days on ventilator [ Time Frame: within NICU stay ]
  • presence of periventricular leucomalacia [ Time Frame: 2 months of life ]
  • presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher [ Time Frame: within hospital stay ]
  • number of days till full enteral feeding [ Time Frame: within first 2 years of life ]
  • presence of gastro-esophagal reflux [ Time Frame: at discharge ]
  • day of surgery [ Time Frame: within hospital stay ]
  • requirement for use of patch for repair [ Time Frame: at the time of surgery ]
  • neurodevelopment at 12 and 24 months [ Time Frame: 24 months ]
  • pulmonary function at one year of age [ Time Frame: one year of age ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Diseases
  • Diaphragmatic Hernia
  • Pulmonary Hypoplasia
Intervention  ICMJE
  • 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
  • Other: watchful waiting during pregnancy
    pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
Study Arms  ICMJE
  • Placebo Comparator: expectant management during pregnancy
    watchful waiting during pregnancy
    Intervention: Other: watchful waiting during pregnancy
  • Experimental: fetal endoluminal tracheal occlusion
    fetoscopic balloon occlusion at 27 to 30 weeks of gestation
    Intervention: Procedure: fetal endoluminal tracheal occlusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
116
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)
148
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jan A Deprest, MD +3216344215 Jan.Deprest@uzleuven.be
Contact: Leen Mortier +32 16 34 42 15 leen.mortier@uzleuven.be
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Japan,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01240057
Other Study ID Numbers  ICMJE ML 6277
B32220108118 ( Other Identifier: UZ Gasthuisberg KU Leuven (Belgium) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Deprest, University Hospital, Gasthuisberg
Study Sponsor  ICMJE University Hospital, Gasthuisberg
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Jan Deprest, MD Universitaire Ziekenhuizen Leuven
PRS Account University Hospital, Gasthuisberg
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP