'TOTAL' (Tracheal Occlusion To Accelerate Lung Growth) Trial
Condition: Hernia; Hernia, Diaphragmatic; Hernia, DIaphragmatic, Congenital; Pathological Conditions, Anatomical; Congenital Abnormalities; Congenital Diaphragmatic Hernia; Fetal Anomaly; Fetal Surgery; Pulmonary Hypoplasia
MeSH terms: Congenital Abnormalities; Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic; Pathological Conditions, Anatomical
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will test whether temporary fetoscopic endoluminal tracheal occlusion (FETO)
      rather than expectant management during pregnancy, followed by standardized postnatal
      management, increases survival at discharge and decreases oxygen need at 6 months in case of
      survival till discharge.
    

Detailed description: 
      This is a multi-center, non-blinded randomized controlled trial in fetuses with isolated
      moderate CDH, i.e. moderate lung hypoplasia (as determined by prenatal assessment of lung
      development). It essentially compares fetal therapy added to conventional postnatal care,
      versus expectant prenatal management during pregnancy followed by conventional postnatal
      care.

      Enrollment:

      Following completion of an inclusion/exclusion criteria checklist and obtaining informed
      consent, the subject will be randomized into two groups ("FETO" and "expectant").

      Procedures:

      Group I: Standardized postnatal care (expectant group): mothers will be expectantly managed
      during pregnancies and babies receive standardized postnatal care at a tertiary center used
      to manage babies with CDH. The recommendation is that they adhere to consensus guidelines
      published on the study website.

      Group II: Prenatal intervention (FETO group): patients will undergo fetoscopic tracheal
      occlusion and ideally prenatal reversal of the occlusion followed by standardized postnatal
      care as in I. In this study FETO is to be done between 30 weeks plus 0 day and 31 weeks plus
      6 days and removal of the balloon at 34 weeks plus 0 day to 34 weeks plus 6 days.

      This study trial is a pragmatical or efficacy trial: ideally mothers will deliver after
      removal of the balloon at those tertiary centers, typically offering postnatal care for the
      patient involved. In group II (FETO-group), mothers will, in between placement and removal of
      the balloon, thus carrying a fetus with obstructed airways, ideally remain under the care of
      our local fetal treatment center (further referred to as FETO center). As many as possible
      precautions are taken to avoid problems with balloon removal in case of earlier than expected
      delivery.

        -  Balloons are to be electively removed prior to 35 weeks. FETO centers will provide 24/24
           hours and 7/7 days services for management of fetuses with obstructed airways, either in
           utero or during labor and delivery.

        -  Patients in the study and randomized to FETO, will be encouraged to stay near the FETO
           center. After reversal of the occlusion the patient will be referred to the tertiary
           care center where delivery and postnatal care will be undertaken. If the patient is not
           remaining at or close to the FETO center, the postnatal treatment center should organize
           likewise EXIT services.
    

Intervention name(s): GoldBal2 detachable balloon; Baltaccidbpe100 Delivery Catheter; Standardized postnatal care
Intervention type(s): Device; Device; Other
Intervention description(s): Placement of the balloon using the plug/unplug method.; The catheter assists with implanting the balloon in the plug/unplug method.; After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CDH; Congenital Diaphragmatic Hernia; Fetal Tracheal Occlusion; FETO; plug-unplug; GoldBal2; Balloon; Goldvalve Balloon; TOTAL