Clinical trial NCT02350348: NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia
Official title: NECTARINE: NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia: A European Prospective Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Anaesthesia
Keywords: neonates
infants
anaesthesia
mortality
adverse effects
Epidemiological Study
European Society of Anaesthesiology
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 5500
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and infants from birth to 60 weeks of post-menstrual age

Brief summary: To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive factors that can be responsible for poor outcome.

Detailed description: The recent pharmacological and technological advancements are making paediatric anaesthesia safer, minimizing thereby the risk of serious adverse events. Despite recent advancements, there is still a significant incidence of life-threatening complications following general and regional anaesthesia without complete identification of predictive factors. Several cohort studies reported the incidence of perioperative anaesthetic complications, but the results were generally limited to a single centre.

Hence, a prospective multicentre study "APRICOT" has been recently conducted in order to establish the incidence of some severe critical events and to identify the risk factors for their occurrence \[ClinicalTrials.gov identifier # NCT01878760\]. This European Society of Anaesthesiology Clinical Trial Network project is currently in progress with over 300 participating centres and more than 25,000 patients, from birth to 15 years of age, to be included. The NECTARINE is specifically focussed on the neonatal population.

The NECTARINE aims to include all neonates and infants from birth to 60 weeks of postmenstrual age scheduled for an elective or urgent diagnostic or surgical procedure under sedation or general anaesthesia with or without regional analgesia or under regional anaesthesia. The primary aim of this study is to identify the occurrence of peri-anaesthesia (during and up to the first 120 minutes) interventions needed to treat or improve one of the following: (1) airway management, (2) oxygenation, (3) alveolar ventilation, (4) glycaemia and Na+, (5) cardiovascular instability, (6) body temperature, (7) brain oxygenation, and (8) anaemia. The parameter or the clinical event that has triggered the intervention will be specifically reported. As secondary aims the in- and out- of hospital morbidity and mortality will be studied at 30 and 90 days from anaesthesia.

Following sample size estimation, the plan is to recruit between 5000 children over a period of twelve consecutive weeks, including weekends and after-hours across the 30 European countries represented at the European Society of Anaesthesiology Council or part of geographical Europe.

The 12-week recruitment period will be chosen by each site commencing on 1 January 2016.The last possible inclusion date will be decided by the Study Steering Committee depending on the recruitment rate. Participating hospitals will be provided with data acquisition sheets that enable anonymous standardized recording of all patients' parameters, which will be used by the local institution to fill in the electronic case report form.

Descriptive statistical analysis will be performed for the primary endpoint (occurrence of severe critical events and 95% confidence interval). Univariate and multivariate analysis will be performed to test factors associated with the endpoint. Results of logistic regression will be reported as adjusted odds ratio (OR) with 95 % confidence intervals .

Eligibility criteria: Inclusion Criteria:

* children from birth to 60 weeks of post-menstrual age undergoing anaesthesia for surgical or diagnostic procedures admitted to participating centres during a predetermined 12-week recruitment period
* all elective inpatient or outpatient surgical procedures performed under general anaesthesia with or without regional analgesia, or under regional anaesthesia alone;
* all diagnostic procedures performed under general anaesthesia;
* all urgent or emergency procedures performed in- or out-of-hours.
* all procedures performed in Neonatal Intensive Care Unit (NICU) / Paediatric Intensive Care Unit (PICU) or directly admitted from intensive care to the operating room

Exclusion Criteria:

- Infants aged over 60 weeks of age on the day of surgery.

Primary outcomes:
measure: The incidence of interventions performed by the anaesthesia team in response to (i) a critical event or (ii) a major change of physiological parameters during anaesthesia management.
timeFrame: Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
Secondary outcomes:
measure: The incidence of adverse events
timeFrame: 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
measure: Mortality
timeFrame: up to 30 days after anaesthesia
measure: Morbidity
timeFrame: at 30 days after anaesthesia
measure: In- and out-hospital mortality
timeFrame: 90 days after anaesthesia
measure: In- and out-hospital morbidity
timeFrame: 90 days after anaesthesia
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Odense
country: Denmark
facility: Odense University Hospital
city: Nürnberg
country: Germany
facility: Cnopf'sche Kinderklinik/Klinik Hallerwiese
city: Genoa
country: Italy
facility: Instituto Giannina Gaslini
city: Utrecht
country: Netherlands
facility: Wilhelmina Childrens Hospital
city: Wroclaw
country: Poland
facility: Clinical University Hospital Department of Anaesthesiology and Intensive Care
city: Belgrade
country: Serbia
facility: University Childrens hospital
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
city: Aberdeen
country: United Kingdom
facility: Royal Aberdeen Children's Hospital
city: London
country: United Kingdom
facility: Great Ormond St Hospital for Children's NHS
Study officials:
affiliation: Dept. Anesthesia - Istituto G. Gaslini - Genoa - Italy
name: Nicola Disma, MD
role: STUDY_CHAIR
References:
citation: Disma N, Leva B, Dowell J, Veyckemans F, Habre W. Assessing anaesthesia practice in the vulnerable age group: NECTARINE: A European prospective multicentre observational study. Eur J Anaesthesiol. 2016 Apr;33(4):233-5. doi: 10.1097/EJA.0000000000000414. No abstract available.
citation: Disma N, Engelhardt T, Hansen TG, de Graaff JC, Virag K, Habre W; NECTARINE Group of the European Society of Anaesthesiology and Intensive; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Neonates undergoing pyloric stenosis repair are at increased risk of difficult airway management: secondary analysis of the NEonate and Children audiT of Anaesthesia pRactice IN Europe. Br J Anaesth. 2022 Nov;129(5):734-739. doi: 10.1016/j.bja.2022.07.041. Epub 2022 Sep 6.
citation: Fuchs A, Disma N, Virag K, Ulmer F, Habre W, de Graaff JC, Riva T; NECTARINE Group of the European Society of Anaesthesiology and Intensive Care Clinical Trial Network. Peri-operative red blood cell transfusion in neonates and infants: NEonate and Children audiT of Anaesthesia pRactice IN Europe: A prospective European multicentre observational study. Eur J Anaesthesiol. 2022 Mar 1;39(3):252-260. doi: 10.1097/EJA.0000000000001646.
citation: Disma N, Veyckemans F, Virag K, Hansen TG, Becke K, Harlet P, Vutskits L, Walker SM, de Graaff JC, Zielinska M, Simic D, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; Austria; Belgium; Croatia; Czech Republic; Denmark; Estonia; Finland; France; Germany; Greece; Hungary; Ireland; Italy; Latvia; Lithuania; Luxembourg; Malta; Netherlands; Norway; Poland; Portugal; Romania; Serbia; Slovakia; Slovenia; Spain; Switzerland; Turkey; Ukraine; United Kingdom. Morbidity and mortality after anaesthesia in early life: results of the European prospective multicentre observational study, neonate and children audit of anaesthesia practice in Europe (NECTARINE). Br J Anaesth. 2021 Jun;126(6):1157-1172. doi: 10.1016/j.bja.2021.02.016. Epub 2021 Apr 1.
citation: Disma N, Virag K, Riva T, Kaufmann J, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. Br J Anaesth. 2021 Jun;126(6):1173-1181. doi: 10.1016/j.bja.2021.02.021. Epub 2021 Apr 1.