Main actions during the study
· In each country, the National Principal Investigators (NPI) will send invitations to join the study to all level 3 neonatal units of the country. The NPI will then communicate
the names, emails and telephone numbers of the units that accept to participate to the EUROPAIN STUDY principal investigators
· The NPI is responsible for the coordination of all units in the country and ensures communication with the EUROPAIN STUDY principal investigators
· The NPI will collect demographic data about the participating country.
· A nurse and physician coordinator as well as a data quality manager will be designated for each unit. The nurse and physician coordinator are responsible for informing all the unit staff about the study.
· The EUROPAIN STUDY principal investigators have prepared a specifically designed web-based database to enter data. Data can be entered directly from the patient’s file. A paper copy of this database will be distributed to allow centers that prefer to perform a preliminary entry on paper forms before entering data on the web-based database. The medical coordinator or a person that he (she) will choose will enter the data into these specifically designed databases.
· The physician coordinator will report general statistics of the unit such as number of beds, number of admission, year ventilator-days etc to the Europain study principal investigators.
· Every unit will also report existing local guidelines on sedation and analgesia in ventilated infants, including routines for withdrawal and on the use of pain assessment tools.
· MONITORING PANEL. A monitoring panel will be created to monitor the progress of the study. This panel will ensure communication with all the participating units. This monitoring panel will be constituted by two persons working full-time during the study period. They will be stationed in Paris and working under the responsibility of EUROPAIN STUDY principal investigators.