Swiss neonatal network and Follow up Group

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1 Swiss neonatal network and Follow up Group March 2011 Barbara Brotschi and Cornelia Hagmann

2 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

3 Therapeutic hypothermia Meta-analysis Reduction of death and disability at 18 months RR 0.81, 95% CI , NNT 9 Increased rate of normal survival RR 1.53, 95% CI , 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 Feb 9;340:c363

4 What about Switzerland? Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly 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

5 Background Switzerland 18 neonatal units in Switzerland 15 units treating infants with perinatal asphyxial encephalopathy 11 units providing cooling therapy

6 Cooling centres Cooling Centres n Basel Bern Chur Genf Lausanne Luzern St. Gallen Zürich Kispi Züric USZ

7 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

8 % Resuscitation n = 148 n = Seizures Adrenalin Mechanical ventilation CPAP Cardiac massage O2-supplementation %

9 Cooling methods No of infants = 149 n "Passive" and cold packs Passive Active

10 Cooling systems Criticool Blanketrol II

11 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)

12 Neuromonitoring: EEG EEG n None one EEG only 2x EEG 3x EEG 4x EEG 5 0

13 Neuromonitoring: cus and MRI cus (cooling time) MRI (cooling time) n n None one cus only 6 1 2x cus 3x cus 4x cus None One MRI Two MRI

14 Timing of MRI Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly Feb 16;141:w13145

15 Follow up Hagmann C, Brotschi B et al.hypothermia for perinatal asphyxial encephalopathy. Swiss Med Wkly Feb 16;141:w13145

16 National Asphyxia and Cooling Register

17 Aims of the register

18 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

19 Aims To define most effective cooling strategies Passive cooling vs active cooling To identify adverse events To ensure systematic follow-up of survivors

20 Organisation

21 Organisation Similar organisation as the Swiss Neonatal Network & Follow-Up Group Electronic data transfer Geneva Bale MEM center Bern

22 Organisation Clinics can enter data electronically

23 Organisation

24 Organisation Database is anonymized Individual patients cannot be recognized Authorized by the privacy protection committee of the Swiss Federal Health Department

25 Organisation Regulations for publications Neonatal network Organisation and Regulations

26 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

27 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: /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

28 Documents

29 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

30 Follow up

31 Flow chart for maternity clinics

32 Flow chart inclusion criterias

33 Data sheet (p 1)

34 Data sheet (day1-3)

35 Data sheet (p 4)

36 Appendix

37 Protocol

38 Adverse events

39 Parents information leaflet

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