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

January 31, 2022 updated by: European Society of Anaesthesiology

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St Luc
  • Denmark
      • Odense, Denmark
        • Odense University Hospital
  • Germany
      • Nürnberg, Germany, 90419
        • Cnopf'sche Kinderklinik/Klinik Hallerwiese
  • Italy
      • Genoa, Italy, 6100
        • Instituto Giannina Gaslini
  • Netherlands
      • Utrecht, Netherlands
        • Wilhelmina Childrens Hospital
  • Poland
      • Wroclaw, Poland, 50-556
        • Clinical University Hospital Department of Anaesthesiology and Intensive Care
  • Serbia
      • Belgrade, Serbia, 11000
        • University Childrens Hospital
  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospitals
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Royal Aberdeen Children's Hospital
      • London, United Kingdom, WC1N 1EH
        • Great Ormond St Hospital for Children's NHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Anaesthesiology

Investigators

  • Study Chair: Nicola Disma, MD, Dept. Anesthesia - Istituto G. Gaslini - Genoa - Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

January 15, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NECTARINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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