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

Children Clinical Trial

— NECTARINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350348
• Other study ID #: NECTARINE
• Status: Completed
• Start date: March 2016
• Est. completion date: June 2019

Study information

• Verified date: July 2020
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5500
• Est. completion date: June 2019
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Anaesthesia
• Children

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Bruxelles
Denmark	Odense University Hospital	Odense
Germany	Cnopf'sche Kinderklinik/Klinik Hallerwiese	Nürnberg
Italy	Instituto Giannina Gaslini	Genoa
Netherlands	Wilhelmina Childrens Hospital	Utrecht
Poland	Clinical University Hospital Department of Anaesthesiology and Intensive Care	Wroclaw
Serbia	University Childrens hospital	Belgrade
Switzerland	Geneva University Hospitals	Geneva
United Kingdom	Royal Aberdeen Children's Hospital	Aberdeen
United Kingdom	Great Ormond St Hospital for Children's NHS	London

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Countries where clinical trial is conducted

Belgium,  Denmark,  Germany,  Italy,  Netherlands,  Poland,  Serbia,  Switzerland,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward
Secondary	Mortality	As determined from medical records	up to 30 days after anaesthesia
Secondary	Morbidity	as determined from medical records: until discharge or at 30 days if still in hospital.	at 30 days after anaesthesia
Secondary	In- and out-hospital mortality	As determined from medical records	90 days after anaesthesia
Secondary	In- and out-hospital morbidity	As determined from medical records	90 days after anaesthesia

External Links

•   NECTARINE section of ESAIC Website