EUROPAINsurvey: EUROpean Pain Audit In Neonates

Sponsor
Hôpital Armand Trousseau (Other)
Overall Status
Completed
CT.gov ID
NCT01694745
Collaborator
(none)
6,489
242
8
26.8
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6489 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. The frequency of ventilated neonates receiving sedation and analgesia in different European units [one year]

    Secondary Outcome Measures

    1. The medications used for sedation and analgesia in ventilated neonates across Europe [one year]

    2. The length of use of medications administered for sedation and analgesia in ventilated neonates [one year]

    3. Similarities and differences in sedation and analgesia practices among European countries [one year]

    Other Outcome Measures

    1. 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]

    2. Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 45 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck Innsbruck Austria
    2 Landeskran- kenhaus Leoben Leoben Austria
    3 Universitäts-klinik für Kinder und Jugendheilkunde Salzburg Salzburg Austria
    4 Universitäts klinik für Kinder-und Jugenheilkunde Wien Wien Austria
    5 Universitaire Ziekenhuis Antwerpen Antwerpen Belgium
    6 Hôpital Erasme ULB, Bruxelles Belgium
    7 Centre Hospitalier Universitaire Tivoli La Louvière Belgium
    8 Centre Hospitalier Régional de la Citadelle Liège Belgium
    9 Neonatal Intensiv Care Unit, Arch. Makarios Hospital Nicosia Cyprus
    10 Department of Anesthesiology and Intensive Care, Tallinn Children's Hospital Tallinn Estonia
    11 Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics Tartu Estonia
    12 Helsinki University Hospital Helsinki Finland
    13 Kuopio University Hospital Kuopio Finland
    14 Oulu University Hospital Oulu Finland
    15 Tampere University Hospital Tampere Finland
    16 Turku University Hospital Turku Finland
    17 CHR Félix Guyon Saint Denis La Réunion France
    18 CHU Amiens Amiens France
    19 CHU Angers Angers France
    20 CH Arras Arras France
    21 CH Côte Basque Bayonne France
    22 CHU Besançon Besançon France
    23 CHU Bordeaux Bordeaux France
    24 CHU de Brest Brest France
    25 CHU Caen Caen France
    26 CH Chambéry Chambéry France
    27 CH Cherbourg Cherbourg France
    28 CHU Clermont Ferrand Clermont Ferrand France
    29 CHU Dijon Dijon France
    30 CH Le Havre Le Havre France
    31 CH Le Mans Le Mans France
    32 CHU Lyon Croix Rousse Lyon France
    33 Hôpital Femme,Mère, enfant Lyon France
    34 Hôpital de la conception - APHM Marseille France
    35 CHU de Montpellier Montpellier France
    36 CHU Nancy Nancy France
    37 CHU Nice Nice France
    38 CHU de Nîmes Nîmes France
    39 CHR Orléans Orléans France
    40 CHU Pau Pau France
    41 CHU Poitiers Poitiers France
    42 CHU Reims Reims France
    43 CHU Rennes Rennes France
    44 CH Rouen Rouen France
    45 Ch Saint Etienne Saint-Etienne France
    46 CHRU de Strasbourg Strasbourg France
    47 CHU Toulouse Toulouse France
    48 CHU Tours Tours France
    49 CH Troyes Troyes France
    50 CH Bretagne Atlantique Vannes France
    51 Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg Bamberg Germany
    52 Klinikum Coburg Coburg Germany
    53 Department of Paediatric and Adolescent Medicine University Hospital Erlangen Erlangen Germany
    54 Cnopf'sche Kinderklinik Nuremberg Germany
    55 "Gaia" Maternity Hospital Athens Greece
    56 "Lito" Maternity Hospital Athens Greece
    57 "Mitera" General Maternity and Pediatric Clinic Athens Greece
    58 "Rea" Maternity Hospital Athens Greece
    59 Alexandras Hospital general Athens Greece
    60 Children's Hospital "Agia Sophia" Athens Greece
    61 Helena Venilezoy Maternit y Hospital Athens Greece
    62 University Hospital of Heraklion Heraklion Greece
    63 University of Ioannina Ioannina Greece
    64 University of Patras Patras Greece
    65 1st Dept of Neonatalogy, Aristole University of Thessaloniki Thessaloniki Greece
    66 2nd Dept of Neonatalogy, Aristole University of Thessaloniki Thessaloniki Greece
    67 Menn Esy, Hippokratio General Hospital Thessaloniki Greece
    68 TIN Ospedale San Giovanni di Dio Agrigento Italy
    69 UO TIN Neonatologia AOU Sant'Orsola Malpighi Bologna Italy
    70 TIN Bolzano Bolzano Italy
    71 UO TIN e Patologia Neonatale Camposampiero Italy
    72 TIN Como Valduce Como Italy
    73 U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri Cremona Italy
    74 Ospedale Careggi Firenze Italy
    75 Patologia Neonatale Lodi Lodi Italy
    76 IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico Milano Italy
    77 TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI Milano Italy
    78 TIN Modena Modena Italy
    79 TIN/Neonatologia- fondazione MBBM- H San Gerardo Monza Italy
    80 TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova Padova Italy
    81 UTIN Perugia Perugia Italy
    82 UO Neonatologia Santa Chiara Pisa Italy
    83 TIN A.O.Bianchi-Melacrino-Morelli Reggio Calabria Italy
    84 Azienda Ospedaliera ASMN, Reggio Emilia Reggio Emilia Italy
    85 NICU Rimini Rimini Italy
    86 TIN Ospedale Pediatrico Bambino Gesù Roma Italy
    87 TIN Ospedale San Pietro FBF Roma Italy
    88 Azienda Ospedaliera Universitaria di Sassari Sassari Italy
    89 Ospedale Maria Vittoria, Torino Torino Italy
    90 UO Neonatologia e TIN Ospedale Santa Chiara Trento Italy
    91 UO TIN e Patologia Neonatale Treviso Italy
    92 Patologia Neonatale Ospedale S.M.Misericordia Udine Italy
    93 Terapia Intensiva Neonatale e Pediatrica Verona Italy
    94 U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma Verona Italy
    95 TIN Ospedale San Bortolo Vicenza Italy
    96 Department of Neonatology Lithuanian University of Health Sciences, Kaunas Lithuania
    97 Mater Dei Hospital, Triq Dun Karm Msida Malta
    98 Academic medical Center Amsterdam - Emma Children's Hospital Amsterdam Netherlands
    99 ErasmusMC - Sophia Childrens Hospital Rotterdam Netherlands
    100 University Hospital Utrecht - Wilhelmina Children's Hospital Utrecht Netherlands
    101 Maxima Medical Center Veldhoven Veldhoven Netherlands
    102 Isala Clinics Zwolle - Amalia Children's Hospital Zwolle Netherlands
    103 Haukeland University Hospital Bergen Norway
    104 Nordland Hospital Bodø Norway
    105 Vestre Viken Hospital Drammen Norway
    106 Ostfold Hospital Fredrikstad Norway
    107 Haugesund Hospital Haugesund Norway
    108 Sorlandet Hospital Kristiansand Norway
    109 Sykehuset Innlandet Lillehammer Lillehammer Norway
    110 Akershus University Hospital Lørenskog Norway
    111 Oslo University Hospital - Rikshospitalet Oslo Norway
    112 Oslo University Hospital - Ullevaal Oslo Norway
    113 Telemark Hospital Skien Norway
    114 Stavanger University Hospital Stavanger Norway
    115 University Hospital of North Norway Tromsø Norway
    116 St. Olavs hospital Trondheim Norway
    117 Vestfold Hospital Tønsberg Norway
    118 Aalesund Hospital Ålesund Norway
    119 Oddzial Noworodkow Bydgoszcz Poland
    120 Szpital Wojewódzki Koszalin Koszalin Poland
    121 Children's Memorial Health Institute Warsaw Warsaw Poland
    122 Clinical Hospital Ks.Anna Mazowiecka Warsaw Poland
    123 Department of obstetric and gynecology, medical University of Warsaw Warsaw Poland
    124 Hospital Orłowskiego Warsaw Warsaw Poland
    125 Oddział Neonatologiczny Warsaw Poland
    126 Departement of Neonato- logy Medical University in Wrocław Wrocław Poland
    127 Hospitale Divino Espirito Santo Açores Portugal
    128 Hospital San Marcos Braga Portugal
    129 Maternidade Bissaya Barreto Coimbra Portugal
    130 Maternidade Daniel Matos Coimbra Portugal
    131 Hospitale Espirito Santa Evora Portugal
    132 Hospitale Faro Faro Portugal
    133 Hospitale Vila Nova Gaia Gaia Portugal
    134 Hospital Dona Estefânia Lisboa Portugal
    135 Hospital Santa Maria Lisboa Portugal
    136 Hospitale Amadora Sintra Lisboa Portugal
    137 Hospitale Sao Francisco Xavier Lisboa Portugal
    138 Maternity Dr Alfredo da Costa Lisboa Portugal
    139 Hospitale Funchal Madeira Portugal
    140 Hospital San João Porto Portugal
    141 Complexo Hospitalario Universitario de A Coruña A Coruña Spain
    142 Hospital Universitario Principe de Asturias Alcalá de Henares Spain
    143 Hospital General de Alicante Alicante Spain
    144 Hospital Clinic de Barcelona Barcelona Spain
    145 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    146 Hospital Sant Joan de Déu Barcelona Spain
    147 Hospital Vall d´Hebron Barcelona Spain
    148 Hospital General de Castellón Castellón de la Plana Spain
    149 Hospital Universitario Puerta del Mar Cádiz Spain
    150 Hospital Universitario de Donostia Donostia Spain
    151 Hospital Universitari Josep Trueta Gerona Spain
    152 Hospital Universitario Severo Ochoa Leganés. Madrid Spain
    153 Hospital San Pedro de Logroño Logroño Spain
    154 Hospital Clínico San Carlos (Madrid) Madrid Spain
    155 Hospital General Universitario Gregorio Marañón Madrid Spain
    156 Hospital Infantil Universitario La Paz Madrid Spain
    157 Hospital Universitario 12 de Octubre Madrid Spain
    158 Hospital Universitario Central de Asturias Oviedo Spain
    159 Complejo Hospitalario de Navarra Pamplona Spain
    160 Complexo Hospitalario de Pontevedra Pontevedra Spain
    161 Hospital Universitario de Salamanca Salamanca Spain
    162 Hospital Universitario Marqués de Valdecilla Santander Spain
    163 Complexo Hospitalario Universitario de Santiago Santiago de Compostela Spain
    164 Hospital Virgen Macarena Sevilla Spain
    165 Hospital Virgen de la Salud (Toledo) Toledo Spain
    166 Hospital Universitari i Politecnic La Fe Valencia Spain
    167 Complexo Hospitalario Universitario de Vigo Vigo Spain
    168 Hospital Clínico Lozano Blesa Zaragoza Spain
    169 Hospital Universitario Miguel Servet Zaragoza Spain
    170 Hospital Universitario de Álava Álava Spain
    171 Hospital Lasarettet Falun Sweden
    172 Universitetssjukhuset Lund Sweden
    173 Karolinska University Hospital (Stockholm) Stockholm Sweden
    174 Sachsska Barnsjukhuset (Stockholm) Stockholm Sweden
    175 Akademiska Barnsjukhuset Uppsala Sweden
    176 Universitetssjukhuset Örebro Sweden
    177 Aberdeen Maternity Hospital Aberdeen United Kingdom
    178 Royal United Hospital Bath United Kingdom
    179 Royal Berkshire NHSFT Berkshire United Kingdom
    180 Birmingham Children's Hospital Birmingham United Kingdom
    181 Birmingham Heartlands Hospital Birmingham United Kingdom
    182 Birmingham Womens Hospital Birmingham United Kingdom
    183 Sandwell and West Birmingham Birmingham United Kingdom
    184 Blackpool Teaching Hospital Foundation Trust Blackpool United Kingdom
    185 Royal Bolton Hospital Bolton United Kingdom
    186 Bradford Royal Infirmary Bradford United Kingdom
    187 Royal Alexander Children's Hospital Brighton United Kingdom
    188 Bristol Royal Infirmary Bristol United Kingdom
    189 Southmead Hospital Bristol United Kingdom
    190 St Michael's Hospital, Bristol NICU Bristol United Kingdom
    191 Royal Brompton Hospital Brompton United Kingdom
    192 Burnley General Hospital Burnley United Kingdom
    193 Countess of Chester Chester United Kingdom
    194 North Tees Hospital Cleveland United Kingdom
    195 Colchester General Hospital Colchester United Kingdom
    196 University Hospitals Coventry & Warwick Coventry United Kingdom
    197 Royal Derby Hospital Derby United Kingdom
    198 Royal Devon and Exeter NHS Foundation Trust Devon United Kingdom
    199 Doncaster Royal Infirmary Doncaster United Kingdom
    200 Edinburgh Royal Infirmary Edinburgh United Kingdom
    201 Medway Maritime Hospital Gillingham United Kingdom
    202 Gloucestershire Royal Hospital Gloucestershire United Kingdom
    203 Royal Gwent Hospital Gwent United Kingdom
    204 Airedale NHS Foundation Trust Keighley United Kingdom
    205 Kettering General Hospital Kettering United Kingdom
    206 Leeds General Infirmary Leeds United Kingdom
    207 Leicester Royal infirmary NICU Leicester United Kingdom
    208 Leicester Royal Infirmary PICU Leicester United Kingdom
    209 Leighton or Mid Cheshire NHS Trust Leighton United Kingdom
    210 Liverpool Women's Hospital NICU Liverpool United Kingdom
    211 Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU London United Kingdom
    212 Great Ormond Street Hospital for Sick Children PICU London United Kingdom
    213 Imperial College London NICU London United Kingdom
    214 Royal London Hospital London United Kingdom
    215 Pennine Acute Hospitals NHS Trust Manchester United Kingdom
    216 St Mary's Hospital Manchester United Kingdom
    217 King's Mill Hospital, Mansfield Mansfield United Kingdom
    218 James Cook University Hospital, Middlesborough Middlesborough United Kingdom
    219 West Middlesex University Hospital Middlesex United Kingdom
    220 Newham University Hospital Newham United Kingdom
    221 Northampton General Hospital Neonatal Unit Northampton United Kingdom
    222 Queen's Medical Centre Nottingham United Kingdom
    223 Southport & Ormskirk & District General Hospital Neonatal Unit Ormskirk United Kingdom
    224 John Radcliffe Hospital Oxford United Kingdom
    225 Derriford Hospital, Plymouth Plymouth United Kingdom
    226 Royal Preston Hospital Preston United Kingdom
    227 Queen's Hospital, Romford Romford United Kingdom
    228 Rotherham District General Hospital Rotherham United Kingdom
    229 Jessop Wing, Sheffield Teaching Hospitals NHS Trust Sheffield United Kingdom
    230 Royal Shrewsbury Hospital Shrewsbury United Kingdom
    231 Singleton Hospital Singleton United Kingdom
    232 University Hospital Of North Staffordshire NHS Trust Staffordshire United Kingdom
    233 Great Western Hospitals NHS Foundation Trust Swindon United Kingdom
    234 Musgrove Park Hospital, Taunton Taunton United Kingdom
    235 Royal Cornwall Hospital Treliske United Kingdom
    236 Warrington Hospital Warrington United Kingdom
    237 Calderdale Royal Hospital West Yorkshire United Kingdom
    238 Pinderfields General Hospital West Yorkshire United Kingdom
    239 New Cross Hospital, Wolverhampton Wolverhampton United Kingdom
    240 Worcester Royal Hospital Worcester United Kingdom
    241 University Hospital of South Manchester, Wythenshawe Wythenshawe United Kingdom
    242 York Teaching Hospital NHS Foundation Trust York United Kingdom

    Sponsors and Collaborators

    • Hôpital Armand Trousseau

    Investigators

    • Principal Investigator: Ricardo Carbajal, MD PhD, Armand Trousseau

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    CARBAJAL, Professor, Hôpital Armand Trousseau
    ClinicalTrials.gov Identifier:
    NCT01694745
    Other Study ID Numbers:
    • EUROPAIN Survey
    First Posted:
    Sep 27, 2012
    Last Update Posted:
    Jan 23, 2014
    Last Verified:
    Feb 1, 2013
    Keywords provided by CARBAJAL, Professor, Hôpital Armand Trousseau
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2014