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

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
• •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