'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
Intervention: GoldBal2 detachable balloon; Baltaccidbpe100 Delivery Catheter; Standardized postnatal care
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: CDH; Congenital Diaphragmatic Hernia; Fetal Tracheal Occlusion; FETO; plug-unplug; GoldBal2; Balloon; Goldvalve Balloon; TOTAL

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients aged 18 years or more, who are able to consent,

          2. Singleton pregnancy,

          3. Chromosomally normal fetus,

          4. Gestation at randomization prior to 31 weeks plus 5 days or so that occlusion is done
             at the latest on 31 weeks plus 6 days,

          5. Fetus is estimated to have moderate pulmonary hypoplasia, defined prenatally as:

             • O/E LHR 25-34.9% (included; irrespective of the position of the liver) • O/E LHR
             35-44.9% (included) with intrathoracic liver herniation as determined by ultrasound or
             MRI.

             The O/E LHR will be determined by the FETO centers as follows:

               -  Measurement of the contralateral lung area preferentially by the tracing method
                  at the 4-chamber view of the heart; if by other method adjusted normative ranges
                  must be used.

               -  Measurement of the head circumference at the standard biparietal view of the head

               -  The observed lung area: calculation of the LHR as the ratio of the measurements
                  of the lung area to head circumference

               -  The expected lung area is the lung area of a normal gestational age match, as
                  determined by the head circumference of the index case in a normogram established
                  for the same measurement method (tracing method in this case). A calculator for
                  this will be available on the website of the study.

               -  Calculation of the observed over expected lung area,

          6. Acceptance of randomization and the consequences for the further management during
             pregnancy and thereafter, this includes the required observation following FETO
             surgery, which lasts up to 4 weeks after balloon is in place,

          7. 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," and

          8. Provide written consent to participate.

          9. Fetus with no major anomalies that would impact the clinical course or outcomes.

        Exclusion Criteria:

          1. Maternal contraindication to fetoscopic surgery or severe medical condition in
             pregnancy that make fetal intervention risky,

          2. Technical limitations precluding fetoscopic surgery, such as severe maternal obesity,
             uterine fibroids or potentially others, not anticipated at the time of writing this
             protocol,

          3. Preterm labor, cervix shortened (<15 mm at randomization) or uterine anomaly strongly
             predisposing to preterm labor, placenta previa,

          4. Patient age less than 18 years,

          5. Psychosocial ineligibility, precluding consent,

          6. Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided
             outside the O/E LHR limits for the inclusion criteria, and

          7. Patient refusing randomization, to comply with required 4-week observation after
             balloon placement, or to comply with return to FETO center during the time period the
             airways are occluded or for elective removal of the balloon.

          8. Patient allergic to latex.