Clinical trial NCT01694745: EUROpean Pain Audit In Neonates
Official title: European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Analgesia
Sedation
Intesive Care
Intratracheal Ventilation
Keywords: Newborns
Premature
Pain
Pain assessment
Endotracheal Intubation
Analgesia
Sedation
Longterm effects of pain
Epidemiology
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 6489
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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.

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.

Detailed description: 1.1 Background and rationale The alleviation of pain is a basic and human right regardless of age. Neonates do feel pain and it has been shown that preterm infants are even more vulnerable to pain than older infants. The more vulnerable preterm neonates are precisely those that are more exposed to pain. Neonates admitted to intensive care units, both neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU), undergo dozens or even hundreds of painful procedures during their stay. These painful procedures include, for many of the ICU neonates, a tracheal intubation followed by mechanical ventilation. The pain and stress that are induced by mechanical ventilation as well as by repetitive procedures or painful diseases has led medical staff to use sedation and analgesia in neonates admitted to intensive care units. The subjectivity and difficulty inherent to pain measurement in neonates have probably contributed to a wide variety of neonatal sedation and analgesia practices. To date, these practices have been rarely studied.

Why would sedation and analgesia be necessary? Mechanical ventilation is a potentially painful intervention. Adults often describe mechanical ventilation as a painful and anxiety-provoking experience. The main objectives of sedation and analgesia are: reduction of pain, stress and irritability, promotion of blood pressure stability, promotion of ventilator synchrony and improvement of oxygenation. In the long term, reduced stress, as well as reduced fluctuations in oxygenation and blood pressure is believed to minimize the risks of neurological injury and death. However, the use of sedation and analgesia is only conceivable in the respect of the principle that must accompany all medical actions: first, do no harm.

Pain and stress undergone during the neonatal period can have deleterious short-term and long-term consequences. Some of these consequences have been reduced with adequate analgesic treatment. Current data show the necessity to give adequate sedation and analgesia to ventilated neonates.

Statements promoting the use of sedation and analgesia The increased awareness that neonates feel pain, the ethical obligation to treat this pain with analgesics, the growing body of evidence demonstrating that untreated neonatal pain can lead to altered reactivity to pain that persists throughout infancy and childhood as well as the need for a humane management of neonates have lead to the development of International and National Guidelines promoting the use of analgesics in the neonatal population. These Guidelines state that units that provide neonatal care should develop and implement guidelines concerning neonatal pain. However, the existing literature is still conflicting regarding the use of sedation and analgesia for ventilated neonates. Current data indicate that there is insufficient evidence to recommend the routine use of opioids in mechanically ventilated newborns and that opioids should be used selectively. Sedation and analgesia in non ventilated babies is extremely rare.

Practices across Europe and USA Data on sedation and analgesia practices in ventilated neonates are very rare. In 1995 the SOPAIN study carried out in the United States showed that factors predicting the use of on-going analgesia and sedation in neonates included: mechanical ventilation, higher gestational age, and male gender. In 2005, the French EPIPPAIN study showed that the rate of continuous sedation and analgesia was 69.6% in ventilated neonates with large variations among centers (16.7% to 90.9%). The most frequently used drugs were midazolam and morphine.

To date, there are no data permitting the comparison of neonatal pain management within the European countries. The availability of these data will enable comparison of practices with state-of-the-art knowledge.

Study Hypothesis

The EUROPAIN study is an epidemiological study that is based on the following hypothesis:

* Most newborn ventilated infants receive continuous sedation and analgesia.
* Non ventilated babies are not sedated.
* Morphine, fentanyl and midazolam are the most frequently drugs used in this setting.
* Infrequent use of validated pain assessment tools to monitor sedation and analgesia occurs in ventilated newborn infants.
* Most units have developed written local guidelines for sedation and analgesia in ventilated neonates, but huge variability exists among practitioners in the same unit, across different units in the same country, and across different countries in Europe.
* Development, dissemination, and regular updates of common European standards will improve the care and clinical outcomes of ventilated newborn infants.

1.2 Main objective • To determine the current clinical practices regarding the use of sedative and analgesic drugs for ventilated newborns in different countries in Europe.

1.3 Principal criteria

* The frequency of ventilated neonates receiving sedation and analgesia in different European units
* The medications used for sedation and analgesia in ventilated neonates across Europe.
* The length of use of medications administered for sedation and analgesia in ventilated neonates
* Similarities and differences in sedation and analgesia practices among European countries

1.4 Secondary objectives and criteria

* 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.
* 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.
* To determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices.
* To determine practices to assess and prevent withdrawal syndromes. Secondary criteria
* Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates
* Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs.

1.5 Type of study

• Epidemiological observational study.

1.6 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.

1.7 Justification of number of patients Regarding the number of neonates to include in order to show possible differences in sedation and analgesia practices among the participating European countries, we have considered a scenario where differences are small. Thus, we have chosen an effect size (W) of 0.1. We have also assumed that 15 countries will participate. Using NCSS-PASS 2008 software, we have found that a total sample size of 2303 neonates will achieve 90% power to detect an effect size (W) of 0.1 using a 14 degrees (15 centers) of freedom Chi-Square test with a significance level (alpha) of 0.05. Therefore, we aim at including an average of 154 neonates per participating country.

1.8 Main Actions carried out 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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • The only exclusion criteria of this observational study is the participation of the neonate in a research study including a randomization for the use of sedative or analgesic drugs in ventilated neonates.

Primary outcomes:
measure: The frequency of ventilated neonates receiving sedation and analgesia in different European units
timeFrame: one year
Secondary outcomes:
measure: The medications used for sedation and analgesia in ventilated neonates across Europe
timeFrame: one year
measure: The length of use of medications administered for sedation and analgesia in ventilated neonates
timeFrame: one year
measure: Similarities and differences in sedation and analgesia practices among European countries
timeFrame: one year
Other outcomes:
measure: Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates
timeFrame: one year
measure: Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs
timeFrame: one year
Locations:
city: Innsbruck
country: Austria
facility: Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck
city: Leoben
country: Austria
facility: Landeskran- kenhaus Leoben
city: Salzburg
country: Austria
facility: Universitäts-klinik für Kinder und Jugendheilkunde Salzburg
city: Wien
country: Austria
facility: Universitäts klinik für Kinder-und Jugenheilkunde Wien
city: Antwerpen
country: Belgium
facility: Universitaire Ziekenhuis Antwerpen
city: Bruxelles
country: Belgium
facility: Hôpital Erasme ULB,
city: La Louvière
country: Belgium
facility: Centre Hospitalier Universitaire Tivoli
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
city: Nicosia
country: Cyprus
facility: Neonatal Intensiv Care Unit, Arch. Makarios Hospital
city: Tallinn
country: Estonia
facility: Department of Anesthesiology and Intensive Care, Tallinn Children's Hospital
city: Tartu
country: Estonia
facility: Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Saint Denis
country: France
facility: CHR Félix Guyon
state: La Réunion
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Arras
country: France
facility: CH Arras
city: Bayonne
country: France
facility: CH Côte Basque
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU Caen
city: Chambéry
country: France
facility: CH Chambéry
city: Cherbourg
country: France
facility: CH Cherbourg
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU Dijon
city: Le Havre
country: France
facility: CH Le Havre
city: Le Mans
country: France
facility: CH Le Mans
city: Lyon
country: France
facility: CHU Lyon Croix Rousse
city: Lyon
country: France
facility: Hôpital Femme,Mère, enfant
city: Marseille
country: France
facility: Hôpital de la conception - APHM
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Orléans
country: France
facility: CHR Orléans
city: Pau
country: France
facility: CHU Pau
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CH Rouen
city: Saint-Etienne
country: France
facility: Ch Saint Etienne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Troyes
country: France
facility: CH Troyes
city: Vannes
country: France
facility: CH Bretagne Atlantique
city: Bamberg
country: Germany
facility: Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Erlangen
country: Germany
facility: Department of Paediatric and Adolescent Medicine University Hospital Erlangen
city: Nuremberg
country: Germany
facility: Cnopf'sche Kinderklinik
city: Athens
country: Greece
facility: "Gaia" Maternity Hospital
city: Athens
country: Greece
facility: "Lito" Maternity Hospital
city: Athens
country: Greece
facility: "Mitera" General Maternity and Pediatric Clinic
city: Athens
country: Greece
facility: "Rea" Maternity Hospital
city: Athens
country: Greece
facility: Alexandras Hospital general
city: Athens
country: Greece
facility: Children's Hospital "Agia Sophia"
city: Athens
country: Greece
facility: Helena Venilezoy Maternit y Hospital
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University of Ioannina
city: Patras
country: Greece
facility: University of Patras
city: Thessaloniki
country: Greece
facility: 1st Dept of Neonatalogy, Aristole University of Thessaloniki
city: Thessaloniki
country: Greece
facility: 2nd Dept of Neonatalogy, Aristole University of Thessaloniki
city: Thessaloniki
country: Greece
facility: Menn Esy, Hippokratio General Hospital
city: Agrigento
country: Italy
facility: TIN Ospedale San Giovanni di Dio
city: Bologna
country: Italy
facility: UO TIN Neonatologia AOU Sant'Orsola Malpighi
city: Bolzano
country: Italy
facility: TIN Bolzano
city: Camposampiero
country: Italy
facility: UO TIN e Patologia Neonatale
city: Como
country: Italy
facility: TIN Como Valduce
city: Cremona
country: Italy
facility: U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Lodi
country: Italy
facility: Patologia Neonatale Lodi
city: Milano
country: Italy
facility: IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico
city: Milano
country: Italy
facility: TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI
city: Modena
country: Italy
facility: TIN Modena
city: Monza
country: Italy
facility: TIN/Neonatologia- fondazione MBBM- H San Gerardo
city: Padova
country: Italy
facility: TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova
city: Perugia
country: Italy
facility: UTIN Perugia
city: Pisa
country: Italy
facility: UO Neonatologia Santa Chiara
city: Reggio Calabria
country: Italy
facility: TIN A.O.Bianchi-Melacrino-Morelli
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera ASMN, Reggio Emilia
city: Rimini
country: Italy
facility: NICU Rimini
city: Roma
country: Italy
facility: TIN Ospedale Pediatrico Bambino Gesù
city: Roma
country: Italy
facility: TIN Ospedale San Pietro FBF
city: Sassari
country: Italy
facility: Azienda Ospedaliera Universitaria di Sassari
city: Torino
country: Italy
facility: Ospedale Maria Vittoria, Torino
city: Trento
country: Italy
facility: UO Neonatologia e TIN Ospedale Santa Chiara
city: Treviso
country: Italy
facility: UO TIN e Patologia Neonatale
city: Udine
country: Italy
facility: Patologia Neonatale Ospedale S.M.Misericordia
city: Verona
country: Italy
facility: Terapia Intensiva Neonatale e Pediatrica
city: Verona
country: Italy
facility: U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma
city: Vicenza
country: Italy
facility: TIN Ospedale San Bortolo
city: Kaunas
country: Lithuania
facility: Department of Neonatology Lithuanian University of Health Sciences,
city: Msida
country: Malta
facility: Mater Dei Hospital, Triq Dun Karm
city: Amsterdam
country: Netherlands
facility: Academic medical Center Amsterdam - Emma Children's Hospital
city: Rotterdam
country: Netherlands
facility: ErasmusMC - Sophia Childrens Hospital
city: Utrecht
country: Netherlands
facility: University Hospital Utrecht - Wilhelmina Children's Hospital
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center Veldhoven
city: Zwolle
country: Netherlands
facility: Isala Clinics Zwolle - Amalia Children's Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Bodø
country: Norway
facility: Nordland Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital
city: Fredrikstad
country: Norway
facility: Ostfold Hospital
city: Haugesund
country: Norway
facility: Haugesund Hospital
city: Kristiansand
country: Norway
facility: Sorlandet Hospital
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet Lillehammer
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital - Rikshospitalet
city: Oslo
country: Norway
facility: Oslo University Hospital - Ullevaal
city: Skien
country: Norway
facility: Telemark Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs hospital
city: Tønsberg
country: Norway
facility: Vestfold Hospital
city: Ålesund
country: Norway
facility: Aalesund Hospital
city: Bydgoszcz
country: Poland
facility: Oddzial Noworodkow
city: Koszalin
country: Poland
facility: Szpital Wojewódzki Koszalin
city: Warsaw
country: Poland
facility: Children's Memorial Health Institute Warsaw
city: Warsaw
country: Poland
facility: Clinical Hospital Ks.Anna Mazowiecka
city: Warsaw
country: Poland
facility: Department of obstetric and gynecology, medical University of Warsaw
city: Warsaw
country: Poland
facility: Hospital Orłowskiego Warsaw
city: Warsaw
country: Poland
facility: Oddział Neonatologiczny
city: Wrocław
country: Poland
facility: Departement of Neonato- logy Medical University in Wrocław
city: Açores
country: Portugal
facility: Hospitale Divino Espirito Santo
city: Braga
country: Portugal
facility: Hospital San Marcos
city: Coimbra
country: Portugal
facility: Maternidade Bissaya Barreto
city: Coimbra
country: Portugal
facility: Maternidade Daniel Matos
city: Evora
country: Portugal
facility: Hospitale Espirito Santa
city: Faro
country: Portugal
facility: Hospitale Faro
city: Gaia
country: Portugal
facility: Hospitale Vila Nova Gaia
city: Lisboa
country: Portugal
facility: Hospital Dona Estefânia
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Lisboa
country: Portugal
facility: Hospitale Amadora Sintra
city: Lisboa
country: Portugal
facility: Hospitale Sao Francisco Xavier
city: Lisboa
country: Portugal
facility: Maternity Dr Alfredo da Costa
city: Madeira
country: Portugal
facility: Hospitale Funchal
city: Porto
country: Portugal
facility: Hospital San João
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruña
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Castellón de la Plana
country: Spain
facility: Hospital General de Castellón
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
city: Gerona
country: Spain
facility: Hospital Universitari Josep Trueta
city: Leganés. Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Logroño
country: Spain
facility: Hospital San Pedro de Logroño
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos (Madrid)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pontevedra
country: Spain
facility: Complexo Hospitalario de Pontevedra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud (Toledo)
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario de Vigo
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Álava
country: Spain
facility: Hospital Universitario de Álava
city: Falun
country: Sweden
facility: Hospital Lasarettet
city: Lund
country: Sweden
facility: Universitetssjukhuset
city: Stockholm
country: Sweden
facility: Karolinska University Hospital (Stockholm)
city: Stockholm
country: Sweden
facility: Sachsska Barnsjukhuset (Stockholm)
city: Uppsala
country: Sweden
facility: Akademiska Barnsjukhuset
city: Örebro
country: Sweden
facility: Universitetssjukhuset
city: Aberdeen
country: United Kingdom
facility: Aberdeen Maternity Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Berkshire
country: United Kingdom
facility: Royal Berkshire NHSFT
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospital Foundation Trust
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
city: Brighton
country: United Kingdom
facility: Royal Alexander Children's Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Bristol
country: United Kingdom
facility: St Michael's Hospital, Bristol NICU
city: Brompton
country: United Kingdom
facility: Royal Brompton Hospital
city: Burnley
country: United Kingdom
facility: Burnley General Hospital
city: Chester
country: United Kingdom
facility: Countess of Chester
city: Cleveland
country: United Kingdom
facility: North Tees Hospital
city: Colchester
country: United Kingdom
facility: Colchester General Hospital
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry & Warwick
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Devon
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Infirmary
city: Gillingham
country: United Kingdom
facility: Medway Maritime Hospital
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Royal Hospital
city: Gwent
country: United Kingdom
facility: Royal Gwent Hospital
city: Keighley
country: United Kingdom
facility: Airedale NHS Foundation Trust
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Royal infirmary NICU
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary PICU
city: Leighton
country: United Kingdom
facility: Leighton or Mid Cheshire NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Women's Hospital NICU
city: London
country: United Kingdom
facility: Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Sick Children PICU
city: London
country: United Kingdom
facility: Imperial College London NICU
city: London
country: United Kingdom
facility: Royal London Hospital
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: St Mary's Hospital
city: Mansfield
country: United Kingdom
facility: King's Mill Hospital, Mansfield
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital, Middlesborough
city: Middlesex
country: United Kingdom
facility: West Middlesex University Hospital
city: Newham
country: United Kingdom
facility: Newham University Hospital
city: Northampton
country: United Kingdom
facility: Northampton General Hospital Neonatal Unit
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Ormskirk
country: United Kingdom
facility: Southport & Ormskirk & District General Hospital Neonatal Unit
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital, Plymouth
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital, Romford
city: Rotherham
country: United Kingdom
facility: Rotherham District General Hospital
city: Sheffield
country: United Kingdom
facility: Jessop Wing, Sheffield Teaching Hospitals NHS Trust
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Singleton
country: United Kingdom
facility: Singleton Hospital
city: Staffordshire
country: United Kingdom
facility: University Hospital Of North Staffordshire NHS Trust
city: Swindon
country: United Kingdom
facility: Great Western Hospitals NHS Foundation Trust
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital, Taunton
city: Treliske
country: United Kingdom
facility: Royal Cornwall Hospital
city: Warrington
country: United Kingdom
facility: Warrington Hospital
city: West Yorkshire
country: United Kingdom
facility: Calderdale Royal Hospital
city: West Yorkshire
country: United Kingdom
facility: Pinderfields General Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital, Wolverhampton
city: Worcester
country: United Kingdom
facility: Worcester Royal Hospital
city: Wythenshawe
country: United Kingdom
facility: University Hospital of South Manchester, Wythenshawe
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Armand Trousseau
name: Ricardo Carbajal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carbajal 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.