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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT01240057
• Date of registration: 04/08/2010
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Gasthuisberg
• Public title: Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia TOTAL
• Scientific 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.
• Date of first enrolment: November 2011
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01240057
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States

Contacts

• Name: Jan Deprest, MD
• Affiliation: Universitaire Ziekenhuizen Leuven

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Congenital Diseases

Pulmonary Hypoplasia

Diaphragmatic Hernia

Intervention(s)

Procedure: fetal endoluminal tracheal occlusion

Other: watchful waiting during pregnancy

Primary Outcome(s)

Survival at discharge from neonatal intensive care unit [Time Frame: at discharge from neonatal intensive care unit]

Secondary Outcome(s)

number of days till full enteral feeding [Time Frame: within first 2 years of life]

Need for Extracorporeal membrane oxygenation [Time Frame: during NICU admission]

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

number of days alive in case of postnatal death [Time Frame: during NICU admission]

number of days of ventilatory support [Time Frame: within NICU stay]

presence of gastro-esophagal reflux [Time Frame: at discharge]

bronchopulmonary dysplasia [Time Frame: with the first 8 weeks]

grading of oxygen dependency [Time Frame: born >32 wks: between 28-56d of life; born <32wks: 36wks postmenstrual age]

presence of neonatal sepsis, intraventricular haemorrhage, retinopathy grade III or higher [Time Frame: within hospital stay]

day of surgery [Time Frame: within hospital stay]

prenatal increase in lung volume after FETO [Time Frame: prior to balloon removal]

Defect size [Time Frame: at the time of postnatal surgery]

occurrence of pulmonary hypertension [Time Frame: within first weeks of life]

presence of periventricular leucomalacia [Time Frame: 2 months of life]

requirement for use of patch for repair [Time Frame: at the time of postnatal surgery]

Secondary ID(s)

ML 6277

B32220108118

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mount Sinai Hospital, Canada

King's College Hospital NHS Trust (UK)

1st Department of Obstetrics and Gynecology, Medical University of Warsaw

Mater Mothers' Hospital

The University of Texas Health Science Center, Houston

Hopital Antoine Beclere

Ospedale Pediatrico Bambino Gesù, Rome (IT)

University Hospital, Bonn

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Hospital Clinic of Barcelona

National Center for Child Health and Development, Tokyo (JP)