Study plan

The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit.
The inclusion criteria are:
·    All neonates up to a corrected age of 44 weeks post conception. That means, for example, that a baby of 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.

At the Unit level

·    No modifications of current managing protocols or strategies are required by the participation in the EUROPAIN STUDY. The unit coordinators will only provide data on local protocols to manage procedural pain and sedation and analgesia in neonates as well as on general statistics of the unit. All treatments are authorized for included neonates since this study does not include any intervention
·    A nurse and physician coordinator as well as a data quality manager will be designated for each unit.

At the national level

·    The country coordinator will provide data on national guidelines to treat or prevent procedural or continuous pain in neonates.

Data Collection

·    The duration of data collection for every included infant is 28 days. However, data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital).
·    Data will be collected on individual data collection forms. These forms include demographic data, modes of respiration, continuous or intermittent sedative, analgesic or neuro-blocking drugs, pain assessment and drug withdrawal practices.
·    Paper patient data collection forms are written in English with a subtitled translation in the country language. The web-based databases display questionnaires in the country language.
·    The data collection forms will be completed by the unit nurse or physician coordinator or the person that they will designate.
·    For each center, the duration of the inclusion period will be one month.
·    Data will be entered on a secure web-based questionnaire.