NEonate-Children sTudy of Anaesthesia pRactice IN Europe Epidemiology of Morbidity and Mortality in Neonatal Anaesthesia

NCT02350348 | Completed

• 1 other identifier: NECTARINE
• Study Type: observational
• Target: 5,500
• Locations: 9 countries
• Sites: 10

Brief Summary

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

Conditions

Children; Anaesthesia

Keywords

neonates; infants; anaesthesia; mortality; adverse effects; Epidemiological Study; European Society of Anaesthesiology

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward

• Mortality

  up to 30 days after anaesthesia

• Morbidity

  at 30 days after anaesthesia

• In- and out-hospital mortality

  90 days after anaesthesia

• In- and out-hospital morbidity

  90 days after anaesthesia

Eligibility Criteria

• Age: Up to 60 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates and infants from birth to 60 weeks of post-menstrual age

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (10)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Odense University Hospital

Odense, Denmark

Location

Cnopf'sche Kinderklinik/Klinik Hallerwiese

Nuremberg, 90419, Germany

Location

Instituto Giannina Gaslini

Genoa, 6100, Italy

Location

Wilhelmina Childrens Hospital

Utrecht, Netherlands

Location

Clinical University Hospital Department of Anaesthesiology and Intensive Care

Wroclaw, 50-556, Poland

Location

University Childrens hospital

Belgrade, 11000, Serbia

Location

Geneva University Hospitals

Geneva, Switzerland

Location

Royal Aberdeen Children's Hospital

Aberdeen, AB25 2ZN, United Kingdom

Location

Great Ormond St Hospital for Children's NHS

London, WC1N 1EH, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 26928166 BACKGROUND

• Neumann 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 Jan 16. doi: 10.1002/pan.70115. Online ahead of print.

  PMID: 41546183 DERIVED

• Fuchs 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.

  PMID: 39979152 DERIVED

• 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.

  PMID: 36085092 DERIVED

• 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.

  PMID: 34845167 DERIVED

• 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.

  PMID: 33812668 DERIVED

• 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.

  PMID: 33812665 DERIVED

Study Officials

• Nicola Disma, MD

  Dept. Anesthesia - Istituto G. Gaslini - Genoa - Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 29, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2019
• Last Updated: February 15, 2022

Record last verified: 2020-07

Locations

IT (1); PL (1); DE (1); BE (1); DK (1); GB (2); SE (1); CH (1); NL (1)