5
Participants
Start Date
January 31, 2017
Primary Completion Date
October 31, 2019
Study Completion Date
October 31, 2019
GoldBal2 detachable balloon
Placement of the balloon using the plug/unplug method.
Baltaccidbpe100 Delivery Catheter
The catheter assists with implanting the balloon in the plug/unplug method.
Standardized postnatal care
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
Baylor College of Medicine/Texas Children's Hospital, Houston
Baylor College of Medicine
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Michael A Belfort
OTHER