Inside Health Care : Neonatal Intensive Care - Who Decides? Who Pays? Who Can Afford It? [1 ed.] 9781608057283, 9781608057290

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Inside Health Care: Neonatal Intensive Care -Who Decides? Who Pays? Who Can Afford It? Editor

Oommen P. Mathew Division of Neonatology Department of Pediatrics Georgia Regents University Augusta, Georgia USA

Bentham Science Publishers

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Cover Art Mridula Mathew

CONTENTS Preface

i

List of Contributors

iii

CHAPTERS SECTION I 1.

Neonatal Care in the USA

3

Oommen P. Mathew 2.

Global View of Neonatal Care

26

Dharmapuri Vidyasagar and Ranganath Daruru 3.

Law, Medicine and the Neonate

45

Jonathan M. Fanaroff 4.

Treatment Decision Making in the NICU: A Moral Analysis

55

Kristen B. Coggin and John C. Moskop 5.

Health Care Crisis and Neonatal Care

72

Oommen P. Mathew

SECTION II 6.

Infants Born at the Margin of Viability

91

Gautham Suresh and Mary Fay 7.

Complex Cases in Neonatal Care: Severe Birth Defects Involving Multiple Organs 116 Brian S. Carter

8.

Decision Making in Extremely Low Birth Weight Infants with Necrotizing Enterocolitis 123 Reed A. Dimmitt

9.

Severe Birth Asphyxia: Acute and Long-Term Care

132

Frank X. Placencia 10. ECMO: Cost, Controversy and Ethics

146

Jatinder S. Bhatia and Linda J. Wise 11. Multifetal Gestation

155

Michael V. Zaretsky

SECTION III 12. Solutions: Is there a Light at the End of the Tunnel?

185

Oommen P. Mathew Index

213

i

PREFACE Better health, in the long run, makes an important contribution to the economic well-being and human happiness. Disparities in health care delivery exist everywhere in the world and the United States is no exception. Our health care delivery model, while spending more on health care than any other nation, is not based on health. No one disagrees with the observation that health care in our nation is facing a crisis, but there is polarization and disagreement among policy makers and the public about how to solve this crisis. There are four important variables in health care delivery: access, outcome, costs and consumer satisfaction. Access is limited by affordability and choice and nearly 50 million people are uninsured. In the U.S. our overall outcome is ranked much lower than most developed nations. In general, consumer satisfaction is good and this is mostly based on those who are insured and have ready access. Health care is big business and is 17% of the gross domestic product. Everyone agrees that we are on an unsustainable course and health care costs needs to be reined in. Yet, change is difficult because there are beneficiaries to the status quo. Even hospice care, once a charitable cause, has become a growth industry with nearly 2000 for-profit providers. Life expectancy and infant mortality rates are considered a reflection of the overall health care outcome of a country. The United States’ international ranking in infant mortality fell from 12th in the world in 1960, to 23rd in 1990 to 29th in 2004 and 30th in 2005. In 2006, United States was number 1 in terms of per capita health care spending but ranked 39th for infant mortality and 36th for life expectancy. Our ranking for life expectancy is estimated to drop to 51st in 2012. Countries such as Singapore, Japan and Sweden are far better than the US in infant mortality. If health care spending is the primary determinant of outcome, United States should be way ahead of all other countries. Despite the sophisticated health care system and cutting edge technology, infant mortality rate in the US is higher than that of Cuba. Emphasis on prevention has paved the way for a better outcome in Cuba in spite of its primitive health care technology. This clearly demonstrates a malalignment of resources and priorities in the U.S. We know that a large amount of money is spent on providing care in the intensive care setting to the terminally ill. This includes both spectrums of life: elderly and

ii

the newborn. Yet, so far, very little attention has been focused on the newborn. The primary aim of this eBook is to highlight the lifesaving nature of neonatal care while shining some light on what can be done to contain cost while optimizing care and outcome. In this eBook we look at health care issues from the inside by physicians who are involved in neonatal care. Current status of neonatal intensive care in the USA is reviewed in the first chapter. Global perspective on neonatal care is presented next. Medico-legal issues are an integral part of providing care to the fetus and the newborn in the U.S. and are addressed in the next chapter. Decision making in neonatal care involve multiple variables. The chapter on treatment options explores these questions in details with special emphasis on ethical and moral issues. Neonatal issues contributing to the current health care crisis are addressed next. Cost containment, in a way, is at the center of this crisis. It is also linked to the question of who pays. Resource allocation is a policy issue and should be addressed at the federal and state levels with input from all constituents. Parents of sick neonates and physicians caring for them are consumed by the critical nature of the illness and are ill suited to argue for what is best for the society in the middle of their individual fight. The second part of the eBook is aimed at highlighting difficult treatment options facing the parents and physicians during the course of selected disease processes affecting the newborn. This provides a unique insight and a prism through which one has to look through to understand why intensive care is so expensive. A mother experiencing different stages of guilt of impending loss may take variable period of time to agree on comfort care rather than intensive care. Potential solutions are discussed in the last chapter. Some issues can be fixed by improving efficiency, eliminating waste, and changing incentives, whereas others need to be debated by the society as a whole to arrive at a general consensus. Ultimately, there are no easy solutions or simple shortcuts to the complex problem facing our country today. Technology may turn out to be both a curse and a blessing from the point of health care expenses.

Oommen P. Mathew Georgia Regents University USA

iii

List of Contributors Jatinder S. Bhatia Professor and Chief, Division of Neonatology, Department of Pediatrics, Georgia Regents University, 1120 15th Street, BIW 6033, Augusta, Georgia 30912-3740, USA Brian S. Carter Professor, Department of Pediatrics, University of Missouri-Kansas City, Children’s Mercy Hospital & Clinics, Bioethics Center and Section of Neonatology, 2401 Gillham Road, Kansas City, MO 64110, USA Kristen B. Coggin Cape Fear Neonatology Service, Fayetteville, North Carolina, USA Reed A. Dimmitt Director, UAB Division of Pediatric Gastroenterology and Nutrition, Associate Professor of Pediatrics and Surgery, Divisions of Neonatology and Pediatric GI/Nutrition, University of Alabama at Birmingham, 1600 7th Avenue South, Jarman F. Lowder Building, Suite 618, Birmingham, AL 35233, England Ranganath Daruru Professor, Department of Pediatrics, Osmania Medical College, Superintendant Niloufer Hospital for Women and Children, NTR Health Sciences University, Hyderabad, AP, India Jonathan M. Fanaroff Associate Professor, Department of Pediatrics, CWRU School of Medicine, Director, Rainbow Center for Pediatric Ethics, Co-director, NICU, Rainbow Babies & Children's Hospital/UH Case Medical Center, 11100 Euclid Avenue, Suite 3100, Cleveland, OH 44106, USA Mary Fay Neonatology Fellow, Dartmouth-Hitchcock Medical Center, NH, Lebanon

iv

Oommen P. Mathew Professor, Division of Neonatology, Department of Pediatrics, Georgia Regents University, 1120 15th Street, BIW 6033, Augusta, Georgia 30912-3740, USA John C. Moskop Wallace and Mona Wu Chair in Biomedical Ethics, Department of Internal Medicine, Wake Forest School of Medicine, Medical Center Boulevard, WinstonSalem, NC 27157, USA Frank X. Placencia Assistant Professor, Section of Neonatology, Baylor College of Medicine, 6621 Fannin Street, Suite W6104, Houston, TX 77030, USA Gautham Suresh Associate Professor, Department of Pediatrics and Community & Family Medicine, Geisel School of Medicine, Hanover, NH, USA Dharmapuri Vidyasagar Professor Emeritus, Department of Pediatrics, Affiliate Center for Global Health, University of Illinois at Chicago, Chicago, IL USA &, Adjunct Professor, Public Health Foundation, Delhi, India Linda J. Wise Neonatal ECMO Coordinator, Children’s Hospital of Georgia, Georgia Regents University Augusta, Georgia 30912-3740, USA Michael V. Zaretsky Associate Professor, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, Texas 75390, USA

SECTION I

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3

CHAPTER 1 Neonatal Care in the USA Oommen P. Mathew* Department of Pediatrics, Medical College of Georgia, Georgia Regents University, Augusta, GA, USA Abstract: Innovations in neonatal care began to occur mostly in the second half the 20th century. Infant mortality rate was 26 per 1000 live births in 1960. By 2000 it has been reduced to 6.9. The preliminary infant mortality rate for 2010 was 6.14 per 1,000 live births. U.S. has high rate of prematurity compared to other developed countries. Preterm birth rate peaked at 12.8 in 2006. It fell in 2010 for the 4th year in a row to 11.99 percent. However, the infant mortality rate for black infants was 11.6 per 1,000 live births, more than twice the rate for white infants. Nevertheless, gestational age specific mortality in the U.S. is similar to that of other developed nations.

Keywords: Neonatal care, Infant mortality, Maternal mortality, Neonatal mortality, Late preterm infants, Prematurity, Multiple births, Non-invasive monitoring, Neuroimaging, In vitro Fertilization, HIV, RDS, ROP, Inhaled nitric oxide, Antenatal steroids, Surfactant. INTRODUCTION Evolution of neonatal care in the United States can be traced back to the use of primitive incubators during the early part of the 20th century. Centers dedicated to the care of premature infants were started much later. Modern neonatology is less than a century old. Publication of the first edition of the booklet entitled “Standards and Recommendations for Hospital Care of Newborn Infants” in 1948 by American Academy of Pediatrics (AAP) is one of the earliest milestone of neonatology in the United States. A 1-kg infant who was born in 1960 had a mortality risk of 95% but such an infant has more than 95% probability of survival today. Another milestone is the first meeting of the Perinatal Section of the American Academy of Pediatrics in 1975. Certification of pediatricians with *Address correspondence to Oommen P. Mathew: Department of Pediatrics, Medical College of Georgia, Georgia Regents University, Augusta GA 30912, USA; Tel: 706-721- 2331; Fax: 706-721-7531; E-mail: [email protected] Oommen P. Mathew (Ed) All rights reserved-© 2013 Bentham Science Publishers

4 Inside Health Care: Neonatal Intensive Care

Oommen P. Mathew

special training in neonatology (Sub-Board of Neonatal-Perinatal Medicine of the American Board of Pediatrics) also began in1975. Today there are more than 2500 board certified neonatologists in the U.S. March of Dimes is another organization that has played a vital role in improving neonatal outcome in this country. They published “Toward Improving the Outcome of Pregnancy” [1] synthesizing the ongoing effort of AAP and other professional organizations such as American Medical Association and American College of Obstetrics and Gynecology (ACOG). These efforts led to the regional network of hospitals with three levels of neonatal inpatient care. Seventh edition of “Guidelines for Perinatal Care” jointly developed by the AAP Committee on Fetus and Newborn and ACOG committee on Obstetric Practice was published in October 2012 [2]. Major innovations occurred in the second half of the 20th century leading to the state of the art neonatal care today. All developed countries have seen a remarkable improvement in health during the last century. This is especially true for maternal and child health. Increase in life expectancy and decrease in maternal and infant mortality rates (IMR) highlight this remarkable achievement. In the U.S., life expectancy has nearly doubled, infant mortality rate has decreased by 90%, and maternal mortality decreased by 99%. IMR, for example, was approximately 100 per 1,000 live births in 1900 and was reduced to 6.89 per 1,000 live births in 2000 [3]. From1980 through 2007 alone, life expectancy at birth has increased from 70 to 75 years for men and from 77 to 80 years for women. However, racial and gender disparities in life expectancy continue to persist (Figs. 1 and 2) [4, 5]. Similarly, the infant mortality rate for black infants was 11.6 per 1,000 live births in 2010, 2.2 times the rate for white infants (Table 1). Survival of extremely premature infants is common place today reflecting the current status of neonatal care in this country. However, in order to understand the impact of neonatal care we need to examine the changes in IMR and Neonatal Mortality rates (NMR) during the last several decades. Neonatal mortality continues to be a major component of IMR. Changes in IMR during the last 6 decades of the 20th century are shown in (Fig. 2). IMR was 26 per 1000 live births in 1960, 16.1 in 1975. By 2000 it has been reduced to 6.9. The preliminary infant mortality rate for 2010 was 6.14 per 1,000 live births [6]. During the same period NMR decreased from 18.7 to 4.04 per 1,000 live births in 2010 [6]. A major focus

Neonatal Care in the USA

Inside Health Care: Neonatal Intensive Care 5

of this chapter is to highlight the innovations in neonatal care and their impact on IMR. INFANT MORTALITY RATE Historical Trends in Infant Mortality In the beginning of the 20th century, even the Western industrialized countries suffered from high IMR. During the early part of the 20th century, IMR decreased markedly. Most of these reductions did not come from great technological innovations or marked improvement in the treatment of diseases but were the results of simple changes such as better hygiene, decrease in infectious disease through antibiotics and vaccinations. Improved access to health care, technologic advances, and innovations in maternal and neonatal medicine contributed to the decrease in IMR in the second half of 20th century. Race of mother

80

Black All races White

IMR/1,000 live births

60

40

20

1940

Figure 1: IMR by race is shown [4].

1950

1960

1970

1980 1990 1999

6 Inside Health Care: Neonatal Intensive Care

Oommen P. Mathew

Table 1: U.S. Life Expectancy and IMR in 2010 [6] Life Expectancy (Years)

All Races

White

Black

Male

76.2

76.5

71.8

Female

81.1

81.3

78.0

Infant Mortality rate

6.14

5.19

11.61

85 White female

Age in years

80

Black female

75 70

White male Black male

65 60 0

1970

1975

1980

1985

1990

1995

2000

2005 2009

Figure 2: Life expectancy in the U.S. by race and sex is shown. Reproduced from references [5].

Overall death rate in the U.S. was 18/1000 in 1900 which decreased to 11 per 1000 by 1940. A substantial portion of the death rate was due to infectious disease. In 1900, 40% of deaths were due to infectious disease; by 1936 it has decreased to 18%. Overall mortality dropped at an average rate of 1% per year; life expectancy also rose from 47 to 63 years [7]. IMR decreased to 71 per 1000 over the same period. In their analysis, Cutler et al. [7] argue that large scale public health measures of water purification and sanitation is primarily responsible for the reduced overall mortality during this period. Seventy-five percent of IMR reduction was attributed to clean water technology. Further improvements in IMR did not occur until after the introduction of antibiotics, oxygen therapy, and nutritional support in 1940s and 1950s.

Neonatal Care in the USA

Inside Health Care: Neonatal Intensive Care 7

Both infant mortality and neonatal mortality rates have steadily decreased over the years. The decline in IMR slowed during the period of 1950-65 in the United States when compared to 1935 to 50 (Fig. 3); this was evident in every segment of the infant population. The IMR declined by an average of 4 percent per year during the early era compared to 1 percent per year for the latter. The IMR trends for individual States generally reflected the same pattern as those for the country. NMR declined at 3 percent per year between 1935 and 1949 for white and nonwhite infants; this rate of decline dropped subsequently to 1.0 percent for white infants and 0.3 percent per year for nonwhite. IMR declined rapidly again, by an average of almost 5 percent per year until the early 1980s (Fig. 3). The rate of decline slowed again to an average of 2 percent per year in the next decade. Innovations in the management of respiratory distress syndrome with continuous positive airway pressure, assisted ventilation, antenatal corticosteroid administration, and surfactant have contributed to the overall decrease in neonatal mortality. 50

Deaths per 1,000 live births

40 30

Infant Neonatal

20

Postneonatal

10 0

1940

1950

1960

1970

1980

1990

2000

2009

Figure 3: IMR and NMR trends are shown; reproduced from references [5].

Recent Trends in Fetal and Infant Mortality Over the last decade of the 20th century the IMR declined for an average decrease of 3 percent per year. The NMR declined from 5.8 to 4.5 per 1,000 between 1990

8 Inside Health Care: Neonatal Intensive Care

Oommen P. Mathew

and 2001. During this period, the late fetal mortality rate declined steadily as well (from 4.3 to 3.3 per 1,000). This significant decline in late fetal mortality and infant mortality occurred despite increases in preterm births. 7 6

IMR

5

3

2 1 0

2000

2002

2004

Figure 4: IMR trend in recent years is shown.

Years

2006

2008

2010

The U.S. infant mortality rate did not decline significantly from 2000 to 2005 (Fig. 4) [3]. Increases in preterm birth and preterm-related infant mortality account for much of the lack of decline in the United States’ infant mortality rate from 2000 to 2005 [3]. Since then it has decreased to 6.14 [6]. IMR has been persistently high in the non-hispanic black. Higher incidence of IMR in nonHispanic black and American Indian may relate in part to differences in risk factors for infant mortality such as preterm and low birth weight delivery, socioeconomic status, access to medical care, etc. However, many of the racial and ethnic differences in infant mortality remain unexplained. Most of the infant deaths during the first week occur in hospitals. Although the absolute number has decreased, congenital malformations and chromosomal anomalies have remained the number one cause of IMR for decades accounting for approximately 20%. In contrast, contribution of SIDS and RDS to IMR has decreased both in absolute and relative terms. Over five thousand infants died of SIDS in 1991 compared to less than two thousand in 2010 [6]. Back to Sleep campaign is primarily responsible for this reduction. Similarly, deaths due to RDS decreased from well over 2500 in 1991 to less than 500 in 2010 (Table 2).

Neonatal Care in the USA

Inside Health Care: Neonatal Intensive Care 9

Surfactant replacement therapy and antenatal steroid use account for this remarkable achievement. Recent declines in infant mortality can be attributed, at least in part, to improvement in birth weight and gestation-specific infant mortality rates which in turn reflect improvements in obstetric and neonatal care. Table 2: The 10 Leading Causes of Infant Mortality for 2010 [6] Rank

Causes of Death

Number

Rate*

1

Congenital malformation, deformation and chromosomal anomalies

5,077

126.9

2

Disorders related to short gestation and low birthweight, not classified elsewhere

4,130

103.2

3

Sudden infant death syndrome (SIDS)

1,890

47.2

4

Newborn affected by maternal complications of pregnancy

1,555

38.9

5

Accidents

1,043

26.1

6

Newborn affected by complications of placenta, cord and membranes

1,030

25.7

7

Bacterial sepsis of newborn

569

14.2

8

Diseases of the circulatory system

499

12.5

9

Respiratory distress of Newborn (RDS)

496

12.4

10

Necrotizing enterocolitis of newborn (NEC)

470

11.7

11

Other causes

7,789

194.7

All causes

24,548

613.7

*Rate /100,000 live births.

The number of births in the United States reached an all-time high of 4.3 million in 2007. The preliminary number of live births for 2010 was 4,000,279. More than 99% of all neonates in the U.S. are born in hospitals. The cesarean section rate has been steadily rising (Fig. 5) [8]. Birth rate decreased in women under forty years across all ethnic groups; only subgroup experiencing an increase in birth rate is women 40 years & over. The number of unmarried women and women 40 and over giving birth have increased significantly across all ethnic groups as well. The birth rate for teenagers aged 15–19 has declined in 2010 to 34.3 births per 1,000 (9% decline from 2009); the lowest rate ever recorded in nearly seven decades. The number of births to teenagers declined to 372,252 in 2010, the fewest since 1946. The overall percentage of preterm births has increased in the United States since the mid-1980s. Preterm birth rate was 10.6% in 1990; 11.6% in 2000 and peaked

10 Inside Health Care: Neonatal Intensive Care

Oommen P. Mathew

at 12.8% in 2006. The preterm birth rate fell in 2010 for the 4th year in a row to 11.99% [8]. Geographic variation in preterm births persists. Mississippi has the highest percentage of preterm birth rate (17.6%) for 2010; Vermont had the lowest prematurity rate (8.4%). The increase in preterm births from the 1980 is attributed in large part to induction of labor and C/S at less than 37 weeks. C/S rate has increased markedly during this period (from approximately 22% to 33%); a small decrease to 32.8 was seen in 2010. A portion of the increase in preterm birth is due to increases in multiple births [9].

Percent of total births

35 30 25 20 15 0

1996

1998

2000

2002

2004

2006

2008

2010

Year Figure 5: C/S rate in U.S. is shown. Reproduced from reference [8].

LATE VS. EARLY PRETERM BIRTHS In the 1990s late preterm (34-36 weeks of gestation) rate began to increase [10] (Fig. 6) but has shown some consistent decline in the last few years; the very preterm rate (less than 32 weeks of gestation) remained fairly constant around 1.9 to 2.0 percent [8] but account for more than half of infant mortality. Late preterm infants are at increased risk compared to term infants; however, they are at substantially lower risk when compared to the very preterm infants.

Neonatal Care in the USA

Inside Health Care: Neonatal Intensive Care 11

10 8 6 4 2 0

1990 1995 2000 2006 2007 2008 2009 2010 34-36 weeks

34 weeks

Figure 6: Early (< 34 completed weeks) and late preterm (34-36 completed weeks) birth rates are shown.

MULTIPLE BIRTHS Both twin deliveries and higher order multiple births have increased in recent years. The rate of twin births has climbed from 18.9 per 1,000 births in 1980 to 22.6 in 1990. The twin birth rate rose to an all-time high in 2009 to 33.2 twins per 1,000 total births [11]. The number of triplets, quadruplets, quintuplets, and other higher-order multiples increased rapidly during the1980s and 1990s; it has trended downward during the last decade (Fig. 7). More than half of multiple births are born preterm. The triplet and higher order multiple birth rate rose to 153.5 per 100,000 births in 2009 [11]. The increased use of assisted reproductive therapies has been strongly associated with multiple gestation pregnancies. Refinements in assisted-reproduction technology and guidelines from the American Society for Reproductive Medicine intended to reduce the incidence of higher-order multiple gestation pregnancies may have played a role in the reduction in higher order multiples in recent years. Twin birth rates have risen for non-Hispanic white women, for non-Hispanic black, and for Hispanic women. About a third of triplet births were born very low birth weight (VLBW) (