EUROpean Pain Audit In Neonates
EUROPAINsurvey
European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units
1 other identifier
observational
6,489
17 countries
212
Brief Summary
EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study. The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries. The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes. 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. It will include all neonates up to a corrected age of 44 weeks post conception. The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2012
Shorter than P25 for all trials
212 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 23, 2014
February 1, 2013
8 months
September 25, 2012
January 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The frequency of ventilated neonates receiving sedation and analgesia in different European units
one year
Secondary Outcomes (3)
The medications used for sedation and analgesia in ventilated neonates across Europe
one year
The length of use of medications administered for sedation and analgesia in ventilated neonates
one year
Similarities and differences in sedation and analgesia practices among European countries
one year
Other Outcomes (2)
Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates
one year
Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs
one year
Eligibility Criteria
* 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. * The aim of including all neonates is to both ensure a generalization of the findings to all ventilated and non ventilated neonates admitted to intensive care units and to obtain a clear description of practices across Europe.
You may qualify if:
- All neonates up to a corrected age of 44 weeks post conceptional. That means, for example, that an infant born at 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.
- NOTE: Since this is an observational epidemiological study, all eligible infants of the unit during the study period should be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (242)
Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck
Innsbruck, Austria
Landeskran- kenhaus Leoben
Leoben, Austria
Universitäts-klinik für Kinder und Jugendheilkunde Salzburg
Salzburg, Austria
Universitäts klinik für Kinder-und Jugenheilkunde Wien
Vienna, Austria
Universitaire Ziekenhuis Antwerpen
Antwerp, Belgium
Hôpital Erasme ULB,
Brussels, Belgium
Centre Hospitalier Universitaire Tivoli
La Louvière, Belgium
Centre Hospitalier Régional de la Citadelle
Liège, Belgium
Neonatal Intensiv Care Unit, Arch. Makarios Hospital
Nicosia, Cyprus
Department of Anesthesiology and Intensive Care, Tallinn Children's Hospital
Tallinn, Estonia
Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics
Tartu, Estonia
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
CHR Félix Guyon
Saint-Denis, La Réunion, France
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CH Arras
Arras, France
CH Côte Basque
Bayonne, France
CHU Besançon
Besançon, France
CHU Bordeaux
Bordeaux, France
CHU de Brest
Brest, France
CHU Caen
Caen, France
CH Chambéry
Chambéry, France
CH Cherbourg
Cherbourg, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHU Dijon
Dijon, France
CH Le Havre
Le Havre, France
CH Le Mans
Le Mans, France
CHU Lyon Croix Rousse
Lyon, France
Hôpital Femme,Mère, enfant
Lyon, France
Hôpital de la conception - APHM
Marseille, France
CHU de Montpellier
Montpellier, France
CHU Nancy
Nancy, France
CHU Nice
Nice, France
CHU de Nîmes
Nîmes, France
CHR Orléans
Orléans, France
CHU Pau
Pau, France
CHU Poitiers
Poitiers, France
CHU Reims
Reims, France
CHU Rennes
Rennes, France
CH Rouen
Rouen, France
Ch Saint Etienne
Saint-Etienne, France
CHRU de Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
CHU Tours
Tours, France
CH Troyes
Troyes, France
CH Bretagne Atlantique
Vannes, France
Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg
Bamberg, Germany
Klinikum Coburg
Coburg, Germany
Department of Paediatric and Adolescent Medicine University Hospital Erlangen
Erlangen, Germany
Cnopf'sche Kinderklinik
Nuremberg, Germany
"Gaia" Maternity Hospital
Athens, Greece
"Lito" Maternity Hospital
Athens, Greece
"Mitera" General Maternity and Pediatric Clinic
Athens, Greece
"Rea" Maternity Hospital
Athens, Greece
Alexandras Hospital general
Athens, Greece
Children's Hospital "Agia Sophia"
Athens, Greece
Helena Venilezoy Maternit y Hospital
Athens, Greece
University Hospital of Heraklion
Heraklion, Greece
University of Ioannina
Ioannina, Greece
University of Patras
Pátrai, Greece
1st Dept of Neonatalogy, Aristole University of Thessaloniki
Thessaloniki, Greece
2nd Dept of Neonatalogy, Aristole University of Thessaloniki
Thessaloniki, Greece
Menn Esy, Hippokratio General Hospital
Thessaloniki, Greece
TIN Ospedale San Giovanni di Dio
Agrigento, Italy
UO TIN Neonatologia AOU Sant'Orsola Malpighi
Bologna, Italy
TIN Bolzano
Bolzano, Italy
UO TIN e Patologia Neonatale
Camposampiero, Italy
TIN Como Valduce
Como, Italy
U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri
Cremona, Italy
Ospedale Careggi
Florence, Italy
Patologia Neonatale Lodi
Lodi, Italy
IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico
Milan, Italy
TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI
Milan, Italy
TIN Modena
Modena, Italy
TIN/Neonatologia- fondazione MBBM- H San Gerardo
Monza, Italy
TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova
Padua, Italy
UTIN Perugia
Perugia, Italy
UO Neonatologia Santa Chiara
Pisa, Italy
TIN A.O.Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Azienda Ospedaliera ASMN, Reggio Emilia
Reggio Emilia, Italy
NICU Rimini
Rimini, Italy
TIN Ospedale Pediatrico Bambino Gesù
Roma, Italy
TIN Ospedale San Pietro FBF
Roma, Italy
Azienda Ospedaliera Universitaria di Sassari
Sassari, Italy
Ospedale Maria Vittoria, Torino
Torino, Italy
UO Neonatologia e TIN Ospedale Santa Chiara
Trento, Italy
UO TIN e Patologia Neonatale
Treviso, Italy
Patologia Neonatale Ospedale S.M.Misericordia
Udine, Italy
Terapia Intensiva Neonatale e Pediatrica
Verona, Italy
U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma
Verona, Italy
TIN Ospedale San Bortolo
Vicenza, Italy
Department of Neonatology Lithuanian University of Health Sciences,
Kaunas, Lithuania
Mater Dei Hospital, Triq Dun Karm
Msida, Malta
Academic medical Center Amsterdam - Emma Children's Hospital
Amsterdam, Netherlands
ErasmusMC - Sophia Childrens Hospital
Rotterdam, Netherlands
University Hospital Utrecht - Wilhelmina Children's Hospital
Utrecht, Netherlands
Maxima Medical Center Veldhoven
Veldhoven, Netherlands
Isala Clinics Zwolle - Amalia Children's Hospital
Zwolle, Netherlands
Aalesund Hospital
Ålesund, Norway
Haukeland University Hospital
Bergen, Norway
Nordland Hospital
Bodø, Norway
Vestre Viken Hospital
Drammen, Norway
Ostfold Hospital
Fredrikstad, Norway
Haugesund Hospital
Haugesund, Norway
Sorlandet Hospital
Kristiansand, Norway
Sykehuset Innlandet Lillehammer
Lillehammer, Norway
Akershus University Hospital
Lørenskog, Norway
Oslo University Hospital - Rikshospitalet
Oslo, Norway
Oslo University Hospital - Ullevaal
Oslo, Norway
Telemark Hospital
Skien, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St. Olavs hospital
Trondheim, Norway
Vestfold Hospital
Tønsberg, Norway
Oddzial Noworodkow
Bydgoszcz, Poland
Szpital Wojewódzki Koszalin
Koszalin, Poland
Children's Memorial Health Institute Warsaw
Warsaw, Poland
Clinical Hospital Ks.Anna Mazowiecka
Warsaw, Poland
Department of obstetric and gynecology, medical University of Warsaw
Warsaw, Poland
Hospital Orłowskiego Warsaw
Warsaw, Poland
Oddział Neonatologiczny
Warsaw, Poland
Departement of Neonato- logy Medical University in Wrocław
Wroclaw, Poland
Hospitale Divino Espirito Santo
Açores, Portugal
Hospital San Marcos
Braga, Portugal
Maternidade Bissaya Barreto
Coimbra, Portugal
Maternidade Daniel Matos
Coimbra, Portugal
Hospitale Espirito Santa
Evora, Portugal
Hospitale Faro
Faro, Portugal
Hospitale Vila Nova Gaia
Gaia, Portugal
Hospital Dona Estefânia
Lisbon, Portugal
Hospital Santa Maria
Lisbon, Portugal
Hospitale Amadora Sintra
Lisbon, Portugal
Hospitale Sao Francisco Xavier
Lisbon, Portugal
Maternity Dr Alfredo da Costa
Lisbon, Portugal
Hospitale Funchal
Madeirã, Portugal
Hospital San João
Porto, Portugal
Complexo Hospitalario Universitario de A Coruña
A Coruña, Spain
Hospital Universitario Principe de Asturias
Alcalá de Henares, Spain
Hospital General de Alicante
Alicante, Spain
Hospital Universitario de Álava
Álava, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Sant Joan de Déu
Barcelona, Spain
Hospital Vall d´Hebron
Barcelona, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
Hospital General de Castellón
Castellon, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain
Hospital Universitari Josep Trueta
Girona, Spain
Hospital Universitario Severo Ochoa
Leganés. Madrid, Spain
Hospital San Pedro de Logroño
Logroño, Spain
Hospital Clínico San Carlos (Madrid)
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Infantil Universitario La Paz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Complexo Hospitalario de Pontevedra
Pontevedra, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Virgen de la Salud (Toledo)
Toledo, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Complexo Hospitalario Universitario de Vigo
Vigo, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Hospital Lasarettet
Falun, Sweden
Universitetssjukhuset
Lund, Sweden
Universitetssjukhuset
Örebro, Sweden
Karolinska University Hospital (Stockholm)
Stockholm, Sweden
Sachsska Barnsjukhuset (Stockholm)
Stockholm, Sweden
Akademiska Barnsjukhuset
Uppsala, Sweden
Aberdeen Maternity Hospital
Aberdeen, United Kingdom
Royal United Hospital
Bath, United Kingdom
Royal Berkshire NHSFT
Berkshire, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Birmingham Womens Hospital
Birmingham, United Kingdom
Sandwell and West Birmingham
Birmingham, United Kingdom
Blackpool Teaching Hospital Foundation Trust
Blackpool, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Royal Alexander Children's Hospital
Brighton, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
St Michael's Hospital, Bristol NICU
Bristol, United Kingdom
Royal Brompton Hospital
Brompton, United Kingdom
Burnley General Hospital
Burnley, United Kingdom
Countess of Chester
Chester, United Kingdom
North Tees Hospital
Cleveland, United Kingdom
Colchester General Hospital
Colchester, United Kingdom
University Hospitals Coventry & Warwick
Coventry, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Devon, United Kingdom
Doncaster Royal Infirmary
Doncaster, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
Gloucestershire Royal Hospital
Gloucestershire, United Kingdom
Royal Gwent Hospital
Gwent, United Kingdom
Airedale NHS Foundation Trust
Keighley, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Leicester Royal infirmary NICU
Leicester, United Kingdom
Leicester Royal Infirmary PICU
Leicester, United Kingdom
Leighton or Mid Cheshire NHS Trust
Leighton, United Kingdom
Liverpool Women's Hospital NICU
Liverpool, United Kingdom
Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU
London, United Kingdom
Great Ormond Street Hospital for Sick Children PICU
London, United Kingdom
Imperial College London NICU
London, United Kingdom
Royal London Hospital
London, United Kingdom
Pennine Acute Hospitals NHS Trust
Manchester, United Kingdom
St Mary's Hospital
Manchester, United Kingdom
King's Mill Hospital, Mansfield
Mansfield, United Kingdom
James Cook University Hospital, Middlesborough
Middlesbrough, United Kingdom
West Middlesex University Hospital
Middlesex, United Kingdom
Newham University Hospital
Newham, United Kingdom
Northampton General Hospital Neonatal Unit
Northampton, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom
Southport & Ormskirk & District General Hospital Neonatal Unit
Ormskirk, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Derriford Hospital, Plymouth
Plymouth, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Queen's Hospital, Romford
Romford, United Kingdom
Rotherham District General Hospital
Rotherham, United Kingdom
Jessop Wing, Sheffield Teaching Hospitals NHS Trust
Sheffield, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Singleton Hospital
Singleton, United Kingdom
University Hospital Of North Staffordshire NHS Trust
Staffordshire, United Kingdom
Great Western Hospitals NHS Foundation Trust
Swindon, United Kingdom
Musgrove Park Hospital, Taunton
Taunton, United Kingdom
Royal Cornwall Hospital
Treliske, United Kingdom
Warrington Hospital
Warrington, United Kingdom
Calderdale Royal Hospital
West Yorkshire, United Kingdom
Pinderfields General Hospital
West Yorkshire, United Kingdom
New Cross Hospital, Wolverhampton
Wolverhampton, United Kingdom
Worcester Royal Hospital
Worcester, United Kingdom
University Hospital of South Manchester, Wythenshawe
Wythenshawe, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, United Kingdom
Related Publications (2)
Lago P, Frigo AC, Baraldi E, Pozzato R, Courtois E, Rambaud J, Anand KJ, Carbajal R. Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study. Ital J Pediatr. 2017 Mar 7;43(1):26. doi: 10.1186/s13052-017-0343-2.
PMID: 28270167DERIVEDCarbajal R, Eriksson M, Courtois E, Boyle E, Avila-Alvarez A, Andersen RD, Sarafidis K, Polkki T, Matos C, Lago P, Papadouri T, Montalto SA, Ilmoja ML, Simons S, Tameliene R, van Overmeire B, Berger A, Dobrzanska A, Schroth M, Bergqvist L, Lagercrantz H, Anand KJ; EUROPAIN Survey Working Group. Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study. Lancet Respir Med. 2015 Oct;3(10):796-812. doi: 10.1016/S2213-2600(15)00331-8. Epub 2015 Sep 24.
PMID: 26420017DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Carbajal, MD PhD
Armand Trousseau
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 25, 2012
First Posted
September 27, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
January 23, 2014
Record last verified: 2013-02