Should Zelen pre-randomised consent designs be used in some neonatal trials?

My aim is to suggest that there is a case for using a randomised consent de sign in some neonatal trials. As an example I use the trials of extracorpor eal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertensio n. In some trials the process of obtaining consent has the potential to har m the subject,for example, by disappointing those who end in the control gr oup and by creating additional anxiety at times of acute illness. An exampl e of such were the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avo id or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people , denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer,for e xample. I argue that these objections are not completely persuasive. Howeve r, they are enough to suggest caution in the use of such designs.