Swiss neonatal network and Follow up Group March 2011 Barbara Brotschi and Cornelia Hagmann
Hypoxic ischaemic encephalopathy Neonatal encephalopathy due to perinatal hypoxiaischaemia: clinically defined syndrome in the term infant disturbed neurologic function in the earliest days difficulty with initiating/maintaining respiration depression of muscle tone and reflexes subnormal level of consciousness, seizures high mortality and morbidity require significant resources
Therapeutic hypothermia Meta-analysis Reduction of death and disability at 18 months RR 0.81, 95% CI 0.71-0.93, NNT 9 Increased rate of normal survival RR 1.53, 95% CI 1.22-1.93, NNT 8 Lower rates of severe disability (P=0.006) CP (P=0.004) severe neurodevelopmental delay (P=0.03) severe neuromotor delay (P=0.02) Edwards AD et al. Neurological outcomes at 18 month of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363
What about Switzerland? Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly. 2011 Feb 16;141:w13145 Ramos G., Brotschi B.,Hagmann C. Therapeutic hypothermia in infants with perinatal asphyxial encephalopathy: the last 5 years in Switzerland. Not yet published
Background Switzerland 18 neonatal units in Switzerland 15 units treating infants with perinatal asphyxial encephalopathy 11 units providing cooling therapy
Cooling centres Cooling Centres 60 54 50 40 n 30 28 20 14 18 10 7 6 9 6 6 0 Basel Bern Chur Genf Lausanne Luzern St. Gallen Zürich Kispi Züric USZ
Last 5 years in Switzerland Patients (n=149) Place of birth: 38 (25.5%) inborn infants 110 (73.8%) outborn infants 1 (0.7%) not available 121 (81%) infants survived 28 infants (19%) died
% 100 90 100 80 70 60 50 40 30 20 10 0 90 80 70 60 50 40 30 20 10 0 93.9 94 Resuscitation n = 148 n = 149 81.1 81.2 46.6 47 14.9 14.8 13.4 13.5 7.4 7.4 Seizures Adrenalin Mechanical ventilation CPAP Cardiac massage O2-supplementation %
Cooling methods No of infants = 149 n 90 80 70 60 50 40 30 20 10 0 "Passive" and cold packs Passive Active
Cooling systems Criticool Blanketrol II
Neuromonitoring day 1-4 Day 1 n (%) Day 2 n (%) Day 3 n (%) Day 4 n (%) > Da y 4 n (%) cus 100 (67.1) 52 (34.9) 46 (30.9) 22 (14.8) 36 (24.2) EEG 36 (24.2) 52 (34.9) 30 (20.1) 18 (12.1) 82 (55) aeeg 92 (61.7) 89 (59.7) 79 (53) 71 (47.7) - MRI 1 (0.7) 10 (6.7) 7 (4.7) 16 (10.7) 60 (40.3) MRS 1 (0.7) 4 (2.7) 5 (3.4) 4 (2.7) 51 (34.2)
Neuromonitoring: EEG EEG 80 70 68 60 50 50 n 40 30 26 20 10 0 None one EEG only 2x EEG 3x EEG 4x EEG 5 0
Neuromonitoring: cus and MRI cus (cooling time) MRI (cooling time) n 80 70 60 50 40 30 64 67 140 120 100 80 n 60 117 20 10 0 11 None one cus only 6 1 2x cus 3x cus 4x cus 40 20 0 30 2 None One MRI Two MRI
Timing of MRI Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly. 2011 Feb 16;141:w13145
Follow up Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly. 2011 Feb 16;141:w13145
National Asphyxia and Cooling Register
Aims of the register
Aims To uniform clinical management and follow-up to a high standard treated to a specified protocol minimise risk of inappropriate treatment maximise benefit of treatment with cooling
Aims To define most effective cooling strategies Passive cooling vs active cooling To identify adverse events To ensure systematic follow-up of survivors
Organisation
Organisation Similar organisation as the Swiss Neonatal Network & Follow-Up Group Electronic data transfer Geneva Bale MEM center Bern
Organisation Clinics can enter data electronically https://www.neonet.unibe.ch/easy.htm
Organisation
Organisation Database is anonymized Individual patients cannot be recognized Authorized by the privacy protection committee of the Swiss Federal Health Department
Organisation Regulations for publications www.neonet.ch Neonatal network Organisation and Regulations
Organisation Organisation of the register CH and BB on behalf of the Neonatal network and Follow up group Responsible for data collection Representatives of the participating centres Monitoring of data collection and data quality Register coordinator Organisation of the follow up Register coordinator
Organisation Epidemiology Birth rate in Switzerland 10/1000 population Incidence of perinatal asphyxial encephalopathy: 1-2/1000 births in the developed world estimated number of infants in CH: 76-140/year App. 1/3 of infants with HIE already integrated in a follow up program App. 70 infants/year in addition 7-8 infants per year per center
Documents
Asphyxia map Asphyxia map = tool = quality assurance Each asphyxia map contains Hypothermia protocol Daily work flow and data sheet Adverse events form Parents information leaflet Flow chart inclusion criterias Flow chart for maternity clinics
Follow up
Flow chart for maternity clinics
Flow chart inclusion criterias
Data sheet (p 1)
Data sheet (day1-3)
Data sheet (p 4)
Appendix
Protocol
Adverse events
Parents information leaflet