CompletedNot Applicable

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

Belgium, Denmark, Germany5,500 participantsStarted 2016-03

Plain-language summary

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

Who can participate

Age range

60 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Anaesthesia time : up to 120 minutes post-anaesthesia either in Post Anesthesia Care Unit (PACU) or neonatal ward

Trial details

NCT IDNCT02350348

SponsorEuropean Society of Anaesthesiology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-03

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