APAGBI Project Grant
NECTARINE: NEonate-Children audiT of Anaesthesia pRactice IN Europe. Epidemiology of morbidity and mortality in neonatal anaesthesia: UK participation in a European prospective multicentre observational audit of practice
Dr Suellen Walker
Background
Complications during general anaesthesia are rare, but risks are higher in small babies. Compared to older children and adults, there is little information about how often problems occur during anaesthesia, and what drugs and interventions are most effective in babies. As size and organ function change rapidly after birth, the 'normal' range for vital signs, such as blood pressure, heart rate, oxygen, and blood sugar changes with age. However, it is not clear what degree of change could influence subsequent health or outcome.
Aims
This study will identify how often peri-operative vital signs change and how many critical events occur during anaesthesia in UK babies. In addition, it assesses patient outcome at 90 days.
Methodology
This prospective, observational, multi-centre cohort study involving babies undergoing general anaesthesia in the UK forms part of a large European study entitled "NECTARINE" (NEonate-Children audiT of Anaesthesia pRactice IN Europe). All babies (up to 60 weeks post-menstrual age) requiring anaesthesia for surgery or procedures will be eligible, during a 12-week recruitment period. Usual clinical care will not be altered. As follow-up includes medical record review and/or calling parents at 90 days, Ethics Approval and parental consent will be obtained.
Using a standardized Case Report Form (CRF), anaesthetists will collect data regarding:
- Baby's current health;
- Type of anaesthetic, surgery or procedure;
- Major changes in vital signs and drugs/interventions used to correct them;
- Serious problems, complications or deaths up to 30 days after anaesthesia.
Parents will be contacted at 90 days so we can assess if peri-operative health and/or events during anaesthesia are associated with subsequent poor outcome.
This follow-up is important, but we aim to minimize any potential distress in cases of poor outcome:
- The Consent Form includes parents agreeing to subsequent contact.
- Ninety day follow-up for all UK centres will be performed by nurses from the Somers Clinical Research Facility (Great Ormond Street Hospital, London). A standardized questionnaire will assist accurate and sensitive data collection.
- All parents will receive a stamped envelope and contact details for the Somers Research Facility. Parents can call, or return an included questionnaire, if they wish to withdraw or prefer only the hospital or GP to be contacted for follow-up.
As problems during anaesthesia are rare, we aim to recruit 350-400 UK babies (within 4000 across Europe). The European Society of Anaesthesiology is funding collection and statistical analysis of anonymised electronic data. Funding requested here will guarantee optimal follow-up for UK participants.
Expected outcomes
Current UK and European practice will be documented and compared. The ability of different interventions to maintain vital signs will help identify the most effective treatments. If specific events are associated with worse outcome, the study will identify babies at increased risk, provide information about when interventions are needed, and inform discussions with parents about treatment options.
Implications
Information from this study will allow paediatric anaesthetic specialist societies to develop management guidelines specifically for the care of the youngest and most vulnerable patients.
