Europain Survey Protocol

Important messages for recruitment of patients

Reminder for inclusion period

  • Verify period of recruitment with your National Principal Investigator and Principal Investigators
  • Inclusions start at 0:00 of the first day of the inclusion period and end at 23:59 the last day of this period
  • Monitor admission in the unit using the UNIT LOG. This allows to register all admitted neonates and those included in the study. 
  • For all NEWLY admitted patients, enter required data on the web based questionnaire. The server will generate an identification number.
  • In case of difficulty entering data directly from the patient's files, a PAPER COPY of the online questionnaire can be used to gather data and enter it subsequently on the web based questionnaire.
  • In case of doubt or problem, please email
  • The inclusion period will be determined FOR EACH unit in agreement with the National Principal Investigator.
  • Some Units, in some countries, will start inclusions on October 1st, 2012; others will do that later.
  • During the study period (ONE MONTH- 31 days) ALL NEWLY ADMITTED BABIES in the unit are included, the differences between ventilated and non ventilated babies will be done during the data analysis.
  • 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).

Diagram of inclusion and data gathering period

 The diagram below shows the inclusion period and the length of data collection

Timeline illustrating an example of data collection periods for three infants (black bars). No infant is included after the one-month inclusion period but can, once included, generate data for a maximum of four weeks

Diagram of main organisational steps

Data quality checking

Quality control will be performed as a self-audit at the local hospitals. This quality control will be carried out by the quality control coordinator (independent person designated by the medical coordinator). It will be conducted on 10% of included neonates with a minimum of 5 neonates. A list of patients whose files are to double check will be sent to medical coordinator. The patients to verify will be chosen randomly by the EUROPAIN STUDY principal investigators. We set up a limit of 1% errors in demographic and medical data. If this limit is exceeded, then another 10 % of charts should be checked. If still more than 1 % mistakes are found, all the charts should be double-checked. Found mistakes should, of course, be corrected on the data base.  


An outline of the EUROPAIN SURVEY is available in different languages:

ENGLISH: Outline of the Protocol in English
EUROPAIN protocol V5 on Feb 28_2012 OUTL[...]
Document Adobe Acrobat [43.0 KB]
FRENCH: Résumé du Protocole en Français
Résumé en français EUROPAIN SURVEY.pdf
Document Adobe Acrobat [157.6 KB]
GERMAN: Gliederung des Protokolls in Deutsch
EUROPAIN_STUDY vers German.pdf
Document Adobe Acrobat [30.0 KB]
ITALIAN: Sintesi dello Studio in Italiano
EUROPAIN protocol V5 on Feb 28_2012 ITAL[...]
Document Adobe Acrobat [43.3 KB]
SWEDISH: Svensk sammanfattning av studieprotokollet
Document Adobe Acrobat [56.1 KB]
FINNISH: Suomenkielinen tiivistelmä tutkimusprotokollasta
EUROPAIN protocol Finnish version.pdf
Document Adobe Acrobat [64.8 KB]
SPANISH: Resumen del Estudio EUROPAIN
EUROPAIN protocol V5 SPANISH on Feb 28_2[...]
Document Adobe Acrobat [247.7 KB]
NORWEGIAN: Norsk sammendrag av studieprotokollen
EUROPAIN protocol V5 on Feb 28_2012_Norw[...]
Document Adobe Acrobat [60.2 KB]
Europain Protocol Greek Version.pdf
Document Adobe Acrobat [102.4 KB]
DUTCH: Nederlandse Samenvatting Van De Europese Studie
EUROPAIN protocol with Dutch Summary.pdf
Document Adobe Acrobat [194.4 KB]
LITHUANIAN: Europain Tyrimo Santrauka Nacionaline Kalba
Europain protocol Lithuanian version.pdf
Document Adobe Acrobat [179.5 KB]
EUROPAIN Protocol Polish Version.pdf
Document Adobe Acrobat [72.4 KB]
Europain protocol Portuguese version.pdf
Document Adobe Acrobat [217.6 KB]