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

Completed

• Conditions: Children; Anaesthesia

• Registration Number: NCT02350348
• Lead Sponsor: European Society of Anaesthesiology

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 .

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Study Start: 2016-03
• Primary Completion: 2017-03
• Study Completion: 2019-06
• Status Verified: 2020-07
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
In- and out-hospital morbidity	90 days after anaesthesia	As determined from medical records
The incidence of adverse events	120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward	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)
Morbidity	at 30 days after anaesthesia	as determined from medical records: until discharge or at 30 days if still in hospital.
In- and out-hospital mortality	90 days after anaesthesia	As determined from medical records
Mortality	up to 30 days after anaesthesia	As determined from medical records

Trial Locations

Locations (10)

Cliniques Universitaires St Luc; 🇧🇪 Bruxelles, Belgium

Great Ormond St Hospital for Children's NHS; 🇬🇧 London, United Kingdom

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland

Royal Aberdeen Children's Hospital; 🇬🇧 Aberdeen, United Kingdom

Cnopf'sche Kinderklinik/Klinik Hallerwiese; 🇩🇪 Nürnberg, Germany

Clinical University Hospital Department of Anaesthesiology and Intensive Care; 🇵🇱 Wroclaw, Poland

Wilhelmina Childrens Hospital; 🇳🇱 Utrecht, Netherlands

Instituto Giannina Gaslini; 🇮🇹 Genoa, Italy

Odense University Hospital; 🇩🇰 Odense, Denmark

University Childrens hospital; 🇷🇸 Belgrade, Serbia