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Neonatal ECMO Study of Temperature

Neonatal ECMO Study of Temperature. NEST. Basic ECMO circuit. Recruited 185. ECMO 93. Conventional 92. Deaths 31. Deaths 54. Lost to follow-up 1. Lost to follow-up 3. Assessed at four 61. Assessed at four 35. ECMO Study follow-up at four. Outcome classification. Normal

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Neonatal ECMO Study of Temperature

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  1. Neonatal ECMO Study of Temperature NEST

  2. Basic ECMO circuit

  3. Recruited 185 ECMO 93 Conventional 92 Deaths 31 Deaths 54 Lost to follow-up 1 Lost to follow-up 3 Assessed at four 61 Assessed at four 35 ECMO Study follow-up at four

  4. Outcome classification Normal Impairment No functional loss Disability Mild Little or no support Moderate Needs aids or assistance Severe Constant supervision

  5. Results – Cognitive

  6. Results – Cognitive

  7. Results - Neuromotor

  8. Results – General health

  9. Results – Behaviour

  10. Results – Hearing

  11. Outcome at four years of age

  12. Results – Overall

  13. Overall outcome

  14. “Concept” • Infants receiving ECMO represent a high risk group for cerebral injury • Mild hypothermia appears to be a promising means of offering neuroprotection following hypoxic ischaemic injury

  15. Pilot Study Progress Stage I: 1998 -1999 Twenty neonates recruited Cooled for first 12 hours of ECMO No significant problems found. Stage II: 2000 -2001 Twenty neonates recruited Cooled for the first 24 hours of ECMO Stage III: 2001 Five neonates recruited Cooled to 340c core temperature for the first 48 hours of ECMO

  16. Methods 25 consecutive neonates referred for ECMO (n = 5 per group) Group 1 (Control): Core temp at 370c for five days Group 2: 360c for 24 hours Group 3: 350c for 24 hours Group 4: 340c for 24 hours Group 5: 340c for 48 hours

  17. MethodProtocol: Blood Sampling Points ECMO Cannulation (VA or VV-DLC) 37 0C Cooling 48 H Baseline 2 H 12 H 24 H 36 H Day 3 Day 4 Day 5 Infants were carefully assessed clinically and biologically Blood Samples were drawn from the ECMO circuit sampling port at the times shown

  18. Measurements Serum Assays Cytokines: IL6 and IL8 Molecular Markers of Coagulation: Thrombin-Antithrombin III, Antithrombin III, Plasmin 2 plasminogen Complement: C3a

  19. Measurements Heparin and Platelet Transfusion Requirements Oxygenator resistance: calculated 2, 12 and 24 hourly thereafter using the formula: Pre-oxygenator pressure - post-oxygenator pressure(mmHg) circuit blood flow (ml/min)

  20. Summary of Demographic Data for Study Groups *Comparison of groups by Kruskal-Wallis test (df = 4) values are median (range)

  21. 37.5 37.0 36.5 36.0 Study Group 35.5 5 35.0 Rectal Temperature ('C) * 4 34.5 3 2 34.0 33.5 1 0 20 40 60 80 100 120 Time on ECMO (hours) Median Group Core Temperature During Study Period *Comparing groups 1-5, median rectal temperature SD at 24 hours (Kruskal-Wallis chi-squared = 23.3, df = 4, p<0.001)

  22. Progress and Complications During the Study * Comparison of groups by Kruskal-Wallis (df = 4) † Bleeding at cannula site due to heparin bolus

  23. Cardiovascular Data During Cooling and Rewarming *Denotes patients not cooled Values are median (range)

  24. Results No systemic difference between groups for: • Molecular markers of coagulation • Complement C3a • Cytokines IL6 and IL8 • Platelet transfusion requirements • Oygenator resistance

  25. Mean IL6 (Temperature Groups)

  26. Mean C3a (Temperature Groups)

  27. Conclusions • Applying mild hypothermia (340C) for 24 or 48 hours of neonatal ECMO appears feasible and safe • No major complications related to mild hypothermia were observed in this study.

  28. The next steps A randomised controlled trial

  29. Trial outline • Research question to be addressed: Does cooling neonates (neonate: less than or equal to 28 days of age) requiring ECMO to 34oC for the first 48 to 72 hours of their ECMO run result in improved Bayley scores at 2 years of age? • Trial design:Pragmatic multi-centre randomised controlled trial.

  30. Trial outline • Eligibility • Meeting standard ECMO criteria but no congenital diaphragmatic hernias and no post cardiac ECMO

  31. Trial outline • Blinding • Randomisation • Consent

  32. Trial outline • Minimisation by approach to ECMO (VV or VA).

  33. Trial outline • ECMO management • Organisation

  34. Trial outline • Trial end points • Primary outcome: MDI of the Bayley scales (34) at age of 2 years (24 - 27 months). • Note: Where the MDI cannot be assessed because of severe disability or death, a score of either 40 or 0 will be recorded respectively.

  35. Trial outline Secondary outcomes: • Death • Outcome of a structured neurological assessment • Results of simple questionnaire completed by parents about their child’s health at two years of age. • PDI of the Bayley scales • Visuospatial assessment • Testers rating of child behaviour

  36. Assumed mean Bayley scores of the two arms Assumed SD of Bayley scores Significance Power to detect difference between the two arms Sample size Number needed to be recruited assuming 80%survival to 2 years 85 & 95 15 5% 90 94 118 85 & 95 10 5% 90 42 53 90 & 95 10 5% 90 168 210 Trial Size

  37. Analysis • Intention-to-treat analysis • Pre specified secondary analyses by disease severity and diagnosis

  38. Other issues • Timescale • aEEG • MRI

  39. Thank you

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