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

Infant MortalityThe Effectiveness of Neonatal

Intensive Care

Barry T Bloom, MDProfessor and Interim Chairman

Department of Pediatrics KUSM-W

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

Knowing is not enough,we must apply;

Being willing is not enough,we must do

Johann Wolfgang von Goethe

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

PerspectivePrematurity is Increasing

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

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

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?

Vermont Oxford NetworkInfants 501-1500 grams

0102030405060708090

100

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Any Mortality

AnteNatal Steroids

Su

rfa

cta

nt

Intr

od

uct

ion

An

ten

ata

l Ste

roid

Pu

sh

Vermont Oxford NetworkInfants 501-1500 grams

0

10

20

30

40

50

60

70

80

1990 1991 1992 1993 1994 1995 1996 1997 1998

Dead @ Discharge Complete Steroids Any SteroidsS

urf

act

an

t In

tro

du

ctio

n

An

ten

ata

l Ste

roid

Pu

sh

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

0

5

10

15

20

25

30

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

Any Mortality

Pneumothorax

Nosocomial BacterialInfSevere IVH

Severe ROP

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

0

10

20

30

40

50

60

70

80

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

CLD in <33wkinfants

Surf anytime

PostNatal Steroids

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

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

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

Neonatal Mortality and CLD“Site” makes a difference and overwhelms an effective medicationData from RCT of Surfactant Prophylaxis

-60%-54%-48%-42%-36%-30%-24%-18%-12%

-6%0%6%

12%18%24%30%36%42%48%54%60%66%72%78%

n=

3

n=

6

n=

11

n=

48

n=

14

n=

39

n=

98

n=

38

n=

12

n=

18

n=

32

n=

125

n=

63

n=

72

n=

43

n=

29

n=

58

n=

24

n=

15

n=

10

n=

4

Site

Dif

fere

nce

in P

rim

ary

Ou

tco

me

(Su

rf 2

- S

urf

1)

Grp2-Grp1

Comparison of Infasurf (calf lung surfactant extract) to Survanta (beractant) in the treatment and prevention of respiratory distress syndromeBLOOM BT; KATTWINKEL J, HALL RT Pediatrics 1997, vol. 100, no1, pp. 31-38

Leverage PointsNIC Unit Volume

Small <36 VLBW/yr12% vs 10% Mortality

Leverage Points

Leverage PointGest Age

Leverage PointNICU Size is Important

Leverage PointsLevel of NICU, ADC and Annual Volume

Small <100 VLBW/yr

Impact on MortalityLevel of Care and VLBW Volume

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?

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

FunctionalPhysicalMental HealthSocial / Role

Other (Pain, Health risk)

SatisfactionHealth Care Delivery

Perceived Health Benefit

CostDirect MedicalIndirect Social

ClinicalMorbidityMortality

Complications

Clinical Value CompassWe Think it Matters

What we do in the NICUWhich NICU matters!

But it is not just mortality

Intraventricular Hemorrhage

Retinopathy

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