The AVERT trial was associated with a large number of unexpected babies born to trial staff.
Results With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff.
At one foundation site involved for the entire trial, a total of 15 babies were born to trial staff (four born to main investigators) over eight recruitment years (fig 2).
The primary outcome was the number of trial participants needed to recruit per baby born to trial staff (NNRpB), calculated as the ratio of the total number of patients recruited in AVERT to the number of babies born to trial staff.
Objective To report the number of participants needed to recruit per baby born to trial staff during AVERT, a large international trial on acute stroke, and to describe trial management consequences.
A surprisingly large number of babies were born to AVERT staff during the trial, the unexpected consequences of which included a high number of new recruits, more training, and additional recruitment time and costs.
In the large international trial on acute stroke, AVERT (a very early rehabilitation trial), we became aware early on of a particular phenomenon of another SUSAR special unexpected staff absences registered, owing to babies born to trial clinical staff.
A further 91 babies (total n=120) were born to 97 site staff (table 1).
Eleven additional babies born to AVERT Central staff were not included in the primary analysis, which focused on the effect of birth on recruitment.
He grew up in the Chatham home that had been in the Bennett family for decades, the oldest of two sons born to Ken Bennett, deputy chief of staff in the Chicago mayor's office, and his wife, Lisa, who works in the Illinois attorney general's office.
