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 Mortality
The Effectiveness of Neonatal
Intensive Care
Barry T Bloom, MD
Professor and Interim Chairman
Department of Pediatrics KUSM-W
Thank You and Disclosures

Employee of the University of Kansas School of Medicine – Wichita



Employee of Pediatrix Medical Group of Kansas, PA
Employee of Pediatrix Medical Group, Inc




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Ross Products, Forest, ONY and iNO Therapeutics
Born and Raised Kansan


Biosynexus Pagibaximab
Astellas – Micafungin
Duke Clinical Research Institutes – Fluconazole Prophylaxis
Duke Clinical Research Rapid Start Network
Paid Speaker


Forest Pharmaceuticals, BioSynexus and ONY, Inc
Site Investigator

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NICU Medical Director
Consultant for Clinical Trials


Corporate Medical Director and
Past Director of Clinical Improvement
HCA Wesley Medical Center
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
Professor and Interim Chairman, Department of Pediatrics
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
Perspective
Reducing Mortality from 175 to 10 is different than from 8 to 4
Perspective
Prematurity is Increasing
Perspective
Preterm Infants account for 68% of Deaths
This is where we live and breath…
Perspective
Reducing Mortality demands a reduction in Prematurity or
additional improvement in NICU care
Historical
Evidence Based Interventions

Surfactant
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

Antenatal Steroids


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
Consensus Conference 1992
Are we stuck, or are there additional steps to take?
Antenatal Steroid Push
Surfactant Introduction
100
90
80
70
60
50
40
30
20
10
0
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
Vermont Oxford Network
Infants 501-1500 grams
Any Mortality
AnteNatal Steroids
Vermont Oxford Network
Infants 501-1500 grams
Dead @ Discharge
60
50
40
30
20
10
0
1990
Any Steroids
Antenatal Steroid Push
Surfactant Introduction
80
70
Complete Steroids
1991
1992
1993
1994
1995
1996
1997
1998
Is Neonatal Care Still Improving?
The VO Network Numbers say NO!
30
Any Mortality
25
Pneumothorax
20
Nosocomial Bacterial
Inf
Severe IVH
15
10
5
Severe ROP
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
0
Is Neonatal Care Still Improving?
The VO Network Numbers say NO!
80
70
60
50
40
30
20
10
0
CLD in <33wk
infants
Surf anytime
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
PostNatal Steroids
Neonatal Mortality
Why do proven interventions not work?

Surfactant
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

Antenatal Steroids
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

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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


Not all Neonatal Deaths are RDS related
Learning Curve
Ineffective practice – late and more
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

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1987 – Vermont Oxford network
Recognizing center to center variation from failed process
1998 – NIC/Q collaboration to improve processes
Racial Disparity
The NICU perspective – 80 to 90’s reduced W Inf M more
“OPTING OUT or Futility”
The Contribution of Withholding or Withdrawing Care to Newborn Mortality
Barton and Hodgman Pediatrics Vol 116 (6) Dec 2005
Neonatal Mortality and CLD
“Site” makes a difference and overwhelms an effective medication
Data 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
n=4
Site
n=10
n=15
n=24
n=58
n=29
n=43
n=72
n=63
n=125
n=32
n=18
n=12
n=38
n=98
n=39
n=14
n=48
n=11
n=6
78%
72%
66%
60%
54%
48%
42%
36%
30%
24%
18%
12%
6%
0%
-6%
-12%
-18%
-24%
-30%
-36%
-42%
-48%
-54%
-60%
n=3
Difference in Primary
Outcome (Surf 2 - Surf1)
Grp2-Grp1
Leverage Points
NIC Unit Volume
Small <36 VLBW/yr
12% vs 10% Mortality
Leverage Points
Leverage Point
Gest Age
Leverage Point
NICU Size is Important
Leverage Points
Level of NICU, ADC and Annual Volume
Small <100 VLBW/yr
Impact on Mortality
Level of Care and VLBW Volume
Volume Impact



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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
Clinical Value Compass
We Think it Matters
Satisfaction
Health Care Delivery
Perceived Health Benefit
Functional
Physical
Mental Health
Social / Role
Other (Pain, Health risk)
Cost
Direct Medical
Indirect Social
Clinical
Morbidity
Mortality
Complications
What we do in the NICU
Which NICU matters!
But it is not just mortality
Intraventricular Hemorrhage
Retinopathy
Neonatal Intensive Care

Prevention of Prematurity is critical




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

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Prevention Strategies must have a scientific basis in effectiveness, not just efficacy
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