Information for study participants


To all participants,


Thank you for taking part in the “Tracheal Occlusion To Accelerate Lung growth” or TOTAL-trial for unborn babies with severe or moderate congenital diaphragmatic hernia (CDH). These trials are now finished and the results and their meaning have been reviewed by an independent group of scientists, and are now published. We value you taking part in this study enormously; by doing so you have contributed greatly to progress in the management of this congenital anomaly. It will also help future parents and direct further research. 
We would like to give you the option of viewing the trial results, but we are aware that this message and the study results may cause you distress by revisiting an experience that you may not wish to revisit. With this in mind we would like to provide you with an option to see the results in your own time and with the help of a doctor who managed your pregnancy and baby. This way, if you feel overwhelmed or you have any questions, the doctor can support you and give you additional information. You are under no obligation to view the results.
If you feel you would like to know more about the study outcomes, we invite you, as a second step, to sign up for a summary of the results via the center where you were treated. To protect your anonymity all contacts should be between you and that treatment center. 
The physicians from those centers, who participated in the study, know about the combined results of the trial as well as your individual history. They have been informed that you may want to contact them in due time.  
In summary this is a two-step process, in which you can actively decide whether you wish to receive the overall study results and find out who is your potential contact for a personalized discussion at the center close to you. This two-step process is what is recommended by professional societies in the field of paediatrics(1). In addition, you can also request the medical publication if you wish.
Yours Sincerely, the TOTAL trial principal investigators
UZ Leuven, Belgium – Jan Deprest (PI)
King’s College Hospital – Kypros Nicolaides
Hospital Clinic – Eduard Gratacos
Hôpital Antoine Béclère, Paris – Alexandra Benachi
Uniklinik Bonn, Bonn – Christoph Berg
Maggiore Policlinico, Milano – Nicola Persico
Baylor College of Medicine, Houston – Michael Belfort
Mater Mother’s Hospital, Brisbane – Glenn Gardener
Mount Sinai, Toronto – Greg Ryan
Necker Enfants Malades, Paris – Yves Ville
Children’s Memorial Hermann, Houston – Anthony Johnson
Medical University Hospital, Warsaw – Miroslaw Wielgos
National Center for Child Health, Tokyo – Haruhiko Sago
Bambino Gesu, Rome – Francesco Morini