Infant Mortality The Effectiveness of Neonatal Intensive Care

1. For I was assailed by so many doubts and errors that the only profit I appeared to have drawn from trying to become educated, was progressively to have discovered my ignorance. Descartes, Discourse on Method, 1637

2. Infant MortalityThe Effectiveness of Neonatal Intensive Care Barry T Bloom, MD Professor and Interim Chairman Department of Pediatrics KUSM-W

3. Thank You and Disclosures • Employee of the University of Kansas School of Medicine – Wichita • Professor and Interim Chairman, Department of Pediatrics • Employee of Pediatrix Medical Group of Kansas, PA • Employee of Pediatrix Medical Group, Inc • Corporate Medical Director and • Past Director of Clinical Improvement • HCA Wesley Medical Center • NICU Medical Director • Consultant for Clinical Trials • Forest Pharmaceuticals, BioSynexus and ONY, Inc • Site Investigator • Biosynexus Pagibaximab • Astellas – Micafungin • Duke Clinical Research Institutes – Fluconazole Prophylaxis • Duke Clinical Research Rapid Start Network • Paid Speaker • Ross Products, Forest, ONY and iNO Therapeutics • Born and Raised Kansan • KC, Sterling, Overland Park, Wichita, Lawrence, Wichita • I am an intensivist not a politician . . . Analysis paralysis causes death in my world

4. Knowing is not enough,we must apply;Being willing is not enough,we must do Johann Wolfgang von Goethe

5. PerspectiveReducing Mortality from 175 to 10 is different than from 8 to 4

6. PerspectivePrematurity is Increasing

7. PerspectivePreterm Infants account for 68% of DeathsThis is where we live and breath…

8. PerspectiveReducing Mortality demands a reduction in Prematurity or additional improvement in NICU care

9. HistoricalEvidence Based Interventions • Surfactant • Prophylactic treatment of very premature infants with human surfactant. “50% reduction in RDS Mortality” • Merritt TA, Hallman M, Bloom BT, Berry C, Benirschke K, Sahn D et al. N Engl J Med 1986; 315:785-90 • FDA – Treatment IND 1990, Approval 1991 • Antenatal Steroids • Consensus Conference 1992 • Are we stuck, or are there additional steps to take?

10. Vermont Oxford NetworkInfants 501-1500 grams Antenatal Steroid Push Surfactant Introduction

11. Vermont Oxford NetworkInfants 501-1500 grams Surfactant Introduction Antenatal Steroid Push

12. Is Neonatal Care Still Improving?The VO Network Numbers say NO!

13. Is Neonatal Care Still Improving?The VO Network Numbers say NO!

14. Neonatal MortalityWhy do proven interventions not work? • Surfactant • Not all Neonatal Deaths are RDS related • Learning Curve • Ineffective practice – late and more • Antenatal Steroids • Maximum benefit may have been reached, no incremental improvement to patients without the target conditions. Those with the target condition do not present for treatment in time. • Racial Disparity • Excess GA-adjusted white mortality was sensitive to interventions • Raw mortality increasing because of GA drift – increasing prematurity • Families Opt Out • Site Performance - Quality Initiatives – improving effectiveness • 1987 – Vermont Oxford network • Recognizing center to center variation from failed process • 1998 – NIC/Q collaboration to improve processes

15. Racial DisparityThe NICU perspective – 80 to 90’s reduced W Inf M more

16. “OPTING OUT or Futility”The Contribution of Withholding or Withdrawing Care to Newborn MortalityBarton and Hodgman Pediatrics Vol 116 (6) Dec 2005

17. Neonatal Mortality and CLD“Site” makes a difference and overwhelms an effective medicationData from RCT of Surfactant Prophylaxis Comparison of Infasurf (calf lung surfactant extract) to Survanta (beractant) in the treatment and prevention of respiratory distress syndrome BLOOM BT; KATTWINKEL J, HALL RT Pediatrics 1997, vol. 100, no1, pp. 31-38

18. Leverage PointsNIC Unit Volume Small <36 VLBW/yr 12% vs 10% Mortality

19. Leverage Points

20. Leverage PointGest Age

21. Leverage PointNICU Size is Important

22. Leverage PointsLevel of NICU, ADC and Annual Volume Small <100 VLBW/yr

23. Impact on MortalityLevel of Care and VLBW Volume

24. Volume Impact • 50% of Infant Mortality comes from the VLBW population • The OR based upon volume is 1.3-1.9 • How much could we lower IMR if we used volume as a critical determinant of where care is provided? • Critical Points • Is every large center really better? • Is every small center really worse?

25. Thinking is easy, acting is difficult, and to put one's thoughts into action is the most difficult thing in the world Johann Wolfgang von Goethe

26. Clinical Value CompassWe Think it Matters

28. What we do in the NICUWhich NICU matters!

29. But it is not just mortality

30. Intraventricular Hemorrhage

31. Retinopathy

32. Neonatal Intensive Care • Prevention of Prematurity is critical • Prevention Strategies must have a scientific basis in effectiveness, not just efficacy • Neonatal Care maintains survival rates while prematurity increases (1980-2009) • The plateau or increase in mortality may be from less effective Neonatal Care • Concentrating resources to improve care • Shifting from high points of leverage with proven effectiveness to unproven potentially ineffective strategies • Manpower crisis – low volume sites increases demand for scarce resources and lowers efficiency • Increased support, based upon quality, for Neonatologists and NICUs will maintain if not improve mortality • Cost – Benefit analysis demands effectiveness • Profitability only requires the right mix of Commercial and Medicaid • Quality requires much more • We need to link revenue to quality instead of payer mix and contracts • Neonatal Intensive care is expensive, but it works • There is evidence that it works in some NICUs better than others • We have our challenges and are in constant competition with costs, access, inefficiency, ineffectiveness, dissatisfaction, prematurity and illness