EUROpean Pain Audit In Neonates

Pain Clinical Trial

— EUROPAINsurvey  

Official title:

European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694745
• Other study ID #: EUROPAIN Survey
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: January 22, 2014
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2013
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6489
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 45 Weeks

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Analgesia
• Intesive Care
• Intratracheal Ventilation
• Pain
• Sedation

Locations

Country	Name	City	State
Austria	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?	Wien
Belgium	Universitaire Ziekenhuis Antwerpen	Antwerpen
Belgium	Hôpital Erasme ULB,	Bruxelles
Belgium	Centre Hospitalier Universitaire Tivoli	La Louvière
Belgium	Centre Hospitalier Régional de la Citadelle	Liège
Cyprus	Neonatal Intensiv Care Unit,? Arch. Makarios Hospital??	Nicosia
Estonia	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
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital?	Kuopio
Finland	Oulu University Hospital?	Oulu
Finland	Tampere University Hospital?	Tampere
Finland	Turku University Hospital?	Turku
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	CHR Félix Guyon	Saint Denis	La Réunion
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
Germany	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?
Greece	"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	Patras
Greece	1st Dept of Neonatalogy, Aristole University of Thessaloniki	Thessaloniki
Greece	Menn Esy, Hippokratio General Hospital	Thessaloniki
Greece	2nd Dept of Neonatalogy, Aristole University of Thessaloniki?	Thessaloniki?
Italy	Terapia Intensiva Neonatale e Pediatrica	?Verona
Italy	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	Firenze
Italy	Patologia Neonatale Lodi	Lodi
Italy	IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico	Milano
Italy	TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI?	Milano
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?	Padova
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	U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma	Verona
Italy	TIN Ospedale San Bortolo	Vicenza
Lithuania	Department of Neonatology Lithuanian University of Health Sciences,?	Kaunas
Malta	Mater Dei Hospital, Triq Dun Karm	Msida
Netherlands	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
Norway	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	Vestfold Hospita?l	Tønsberg
Norway	University Hospital of North Norway?	Tromsø?
Norway	St. Olavs hospital?	Trondheim?
Poland	Oddzial Noworodkow?	Bydgoszcz
Poland	Szpital Wojewódzki Koszalin?	Koszalin?
Poland	Clinical Hospital Ks.Anna Mazowiecka?	Warsaw
Poland	Department of obstetric and gynecology, medical University of Warsaw?	Warsaw
Poland	Oddzial Neonatologiczny?	Warsaw
Poland	Children's Memorial Health Institute Warsaw?	Warsaw?
Poland	Hospital Orlowskiego Warsaw?	Warsaw?
Poland	Departement of Neonato- logy Medical University in Wroclaw?	Wroclaw?
Portugal	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	Lisboa
Portugal	Hospital Santa Maria	Lisboa
Portugal	Hospitale Amadora Sintra	Lisboa
Portugal	Hospitale Sao Francisco Xavier	Lisboa
Portugal	Maternity? Dr Alfredo da? Costa?	Lisboa
Portugal	Hospitale Funchal	Madeira
Portugal	Hospital San João	Porto
Spain	Complexo Hospitalario Universitario? de A Coruña?	A Coruña?
Spain	Hospital Universitario de Álava	Álava
Spain	Hospital Universitario Principe de Asturias?	Alcalá de Henares
Spain	Hospital General de Alicante?	Alicante?
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	Cádiz
Spain	Hospital General de Castellón	Castellón de la Plana?
Spain	Hospital Universitario de Donostia	Donostia
Spain	Hospital Universitari Josep Trueta	Gerona
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	Sevilla
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
Sweden	Hospital Lasarettet?	Falun
Sweden	Universitetssjukhuset?	Lund
Sweden	Universitetssjukhuset?	Örebro?
Sweden	Karolinska University Hospital? (Stockholm)	Stockholm
Sweden	Sachsska Barnsjukhuset? (Stockholm)	Stockholm
Sweden	Akademiska Barnsjukhuset?	Uppsala
United Kingdom	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	St Michael's Hospital, Bristol NICU?	Bristol
United Kingdom	Southmead Hospital	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?	Middlesborough?
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

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Armand Trousseau

Countries where clinical trial is conducted

Austria,  Belgium,  Cyprus,  Estonia,  Finland,  France,  Germany,  Greece,  Italy,  Lithuania,  Malta,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs		one year	No
Primary	The frequency of ventilated neonates receiving sedation and analgesia in different European units		one year	No
Secondary	The medications used for sedation and analgesia in ventilated neonates across Europe		one year	No
Secondary	The length of use of medications administered for sedation and analgesia in ventilated neonates		one year	No
Secondary	Similarities and differences in sedation and analgesia practices among European countries		one year	No

External Links

•   Study website