ChildrenNECTARINENCT02350348
NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia
An observational study of Children and Anaesthesia, run by European Society of Anaesthesiology at 10 sites in 9 countries.
Trial summary
To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive factors that can be responsible for poor outcome. Read more about this study
- Who is it for?
- Ages Up to 60 weeks
- Conditions the study is for
- Children, Anaesthesia
- How many people
- 5,500 participants
- Where
- 10 sitesin 9 countries
- Study dates
- Mar 2016to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants from birth to 60 weeks of post-menstrual age
Who may be able to join
- 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
Who cannot join
- Infants aged over 60 weeks of age on the day of surgery.
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
United Kingdom2 sites
Royal Aberdeen Children's Hospital
Aberdeen, AB25 2ZN
Great Ormond St Hospital for Children's NHS
London, WC1N 1EH
Poland1 site
Clinical University Hospital Department of Anaesthesiology and Intensive Care
Wroclaw, 50-556
About this study
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
To study the 30-day morbidity and mortality after neonatal anaesthesia, and predictive factors that can be responsible for poor outcome.
Read the 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 .
- Conditions
- Children, Anaesthesia
- Keywords
- neonates, infants, anaesthesia, mortality, adverse effects, Epidemiological Study, European Society of Anaesthesiology
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This is a composite that will include several physiological parameters to be observed: (1) airway management, (2) oxygenation, (3) alveolar ventilation, (4) glycaemia and Na+, (5) cardiovascular instability, (6) body temperature, (7) brain oxygenation, and (8) anaemia.
Measured: Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
Secondary outcomes (5)
The incidence of adverse events
This is a composite that will include:
- Unplanned delayed extubation.
- Need for ECMO (extracorporeal membrane oxygenation).
- Need for chest left open (for cardiac surgery only).
- Unplanned hospital admission (originally scheduled as outpatient)
Measured: 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
Mortality
As determined from medical records
Measured: up to 30 days after anaesthesia
Morbidity
as determined from medical records: until discharge or at 30 days if still in hospital.
Measured: at 30 days after anaesthesia
In- and out-hospital mortality
As determined from medical records
Measured: 90 days after anaesthesia
In- and out-hospital morbidity
As determined from medical records
Measured: 90 days after anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Disma, MD, Study chair, Dept. Anesthesia - Istituto G. Gaslini - Genoa - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350348
- Sponsor's protocol ID
- NECTARINE
- Acronym
- NECTARINE
- Status last verified
- Jul 2020
- First submitted
- 15 Jan 2015
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26928166Neumann C, Schenk A, Schindler E, Becke-Jakob K; German Nectarine Group Collaborators. Epidemiology, Morbidity and Mortality Associated With Anesthesia in Early Life: A Subgroup Analysis of the German NEonate and Children audiT of Anesthesia pRactice IN Europe (NECTARINE) Cohort. Paediatr Anaesth. 2026 Apr;36(4):440-452. doi: 10.1002/pan.70115. Epub 2026 Jan 16.
PubMed 41546183Fuchs A, Disma N, Engelhardt T, Marchesini V, Riedel T, Boda K, Habre W, Riva T; NECTARINE Steering Committee; NECTARINE Group of the European Society of Anaesthesiology and Intensive Care Clinical Trial Network. Ventilation strategies and risk factors for intraoperative respiratory critical events and postoperative pulmonary complications in neonates and small infants: a secondary analysis of the NECTARINE cohort☆. Br J Anaesth. 2025 Nov;135(5):1528-1536. doi: 10.1016/j.bja.2024.12.038. Epub 2025 Feb 20.
PubMed 39979152Disma 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.
PubMed 36085092Fuchs 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.
PubMed 34845167Disma 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.
PubMed 33812668Disma 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.
PubMed 33812665
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02350348
- Acronym / sponsor ID
- NECTARINE / NECTARINE
- Conditions
- Children, Anaesthesia
- Keywords
- neonates, infants, anaesthesia, mortality, adverse effects, Epidemiological Study, European Society of Anaesthesiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants from birth to 60 weeks of post-menstrual age
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Infants aged over 60 weeks of age on the day of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
This is a composite that will include several physiological parameters to be observed: (1) airway management, (2) oxygenation, (3) alveolar ventilation, (4) glycaemia and Na+, (5) cardiovascular instability, (6) body temperature, (7) brain oxygenation, and (8) anaemia.
5 secondary outcomes
The incidence of adverse events
Time frame: 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
Mortality
Time frame: up to 30 days after anaesthesia
Morbidity
Time frame: at 30 days after anaesthesia
In- and out-hospital mortality
Time frame: 90 days after anaesthesia
In- and out-hospital morbidity
Time frame: 90 days after anaesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 26928166Disma 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.
- Derived from this study: PubMed 41546183Neumann C, Schenk A, Schindler E, Becke-Jakob K; German Nectarine Group Collaborators. Epidemiology, Morbidity and Mortality Associated With Anesthesia in Early Life: A Subgroup Analysis of the German NEonate and Children audiT of Anesthesia pRactice IN Europe (NECTARINE) Cohort. Paediatr Anaesth. 2026 Apr;36(4):440-452. doi: 10.1002/pan.70115. Epub 2026 Jan 16.
- Derived from this study: PubMed 39979152Fuchs A, Disma N, Engelhardt T, Marchesini V, Riedel T, Boda K, Habre W, Riva T; NECTARINE Steering Committee; NECTARINE Group of the European Society of Anaesthesiology and Intensive Care Clinical Trial Network. Ventilation strategies and risk factors for intraoperative respiratory critical events and postoperative pulmonary complications in neonates and small infants: a secondary analysis of the NECTARINE cohort☆. Br J Anaesth. 2025 Nov;135(5):1528-1536. doi: 10.1016/j.bja.2024.12.038. Epub 2025 Feb 20.
- Derived from this study: PubMed 36085092Disma 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.
- Derived from this study: PubMed 34845167Fuchs 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.
- Derived from this study: PubMed 33812668Disma 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.
- Derived from this study: PubMed 33812665Disma 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.
- NECTARINE section of ESAIC WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Disma, MD study chair
Dept. Anesthesia - Istituto G. Gaslini - Genoa - Italy
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Anaesthesia, run by European Society of Anaesthesiology at 10 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Belgium, Denmark, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350348, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.