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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 : Active, not recruiting
First Posted : November 15, 2010
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
King's College Hospital NHS Trust (UK)
Hospital Clinic of Barcelona
Hopital Antoine Beclere
University Hospital, Bonn
Mater Mothers' Hospital
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Mount Sinai Hospital, Canada
National Center for Child Health and Development, Tokyo (JP)
The University of Texas Health Science Center, Houston
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 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
Actual Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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 29+6 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 after FETO [ Time Frame: prior to balloon removal ]
    volume of lung after occlusion

  2. grading of oxygen dependency [ Time Frame: born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age ]
  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 of ventilatory support [ 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 postnatal surgery ]
  12. bronchopulmonary dysplasia [ Time Frame: with the first 8 weeks ]
    defined as oxygen need for at least 28 days

  13. Need for Extracorporeal membrane oxygenation [ Time Frame: during NICU admission ]
  14. Defect size [ Time Frame: at the time of postnatal surgery ]
  15. number of days alive in case of postnatal death [ Time Frame: during NICU admission ]


Information from the National Library of Medicine

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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


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Australia, Queensland
Mater Mother's Hospital
Brisbane, Queensland, Australia, 4101
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
France
Hôpital Antoine Béclère
Clamart, France, 92141
Germany
University Hospital of Bonn
Bonn, Germany, 53105
Italy
Ospedale Maggiore Policlinico
Milano, Italy, 20122
Ospedale Pediatrico Bambino Gesù
Rome, Italy, 00123
Japan
National Center for Child Health and Development
Tokyo, Japan, 157-8535
Poland
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Warsaw, Poland
Spain
Hospital Clinic Barcelona
Barcelona, Catalunya, Spain, 08028
United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
University Hospital, Gasthuisberg
King's College Hospital NHS Trust (UK)
Hospital Clinic of Barcelona
Hopital Antoine Beclere
University Hospital, Bonn
Mater Mothers' Hospital
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ospedale Pediatrico Bambino Gesù, Rome (IT)
Mount Sinai Hospital, Canada
National Center for Child Health and Development, Tokyo (JP)
The University of Texas Health Science Center, Houston
1st Department of Obstetrics and Gynecology, Medical University of Warsaw
Investigators
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Principal Investigator: Jan Deprest, MD Universitaire Ziekenhuizen Leuven
Additional Information:
Publications:

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Responsible Party: Jan Deprest, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01240057    
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: November 24, 2020
Last Verified: November 2020
Keywords provided by Jan Deprest, University Hospital, Gasthuisberg:
Isolated Congenital Diaphragmatic Hernia
Fetal Surgery
Pulmonary Hypoplasia
Additional relevant MeSH terms:
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Hernias, Diaphragmatic, Congenital
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities