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Historical Review and Recent Advances
in Neonatal and Perinatal Medicine

Edited by George F. Smith, MD and Dharmapuri Vidyasagar, MD
Published by Mead Johnson Nutritional Division, 1980
Not Copyrighted By Publisher

Chapter 22

The Impact of Regionalization on Neonatal Outcome

L. Joseph Butterfield, M. D.

 

Regionalization of health care is not new. Some form of it has been advocated in the health care delivery system for nearly sixty years but the execution of the concept has not fared well in the diversified health care delivery system in the United States.[1]

The Regional Medical Program (1965) targeted heart disease, cancer and stroke as conditions that would benefit from regionalization but the program suffered and died of fiscal malnutrition and was relegated to being another great American idea.[2]

The Comprehensive Health Planning Law (PL89-749) was developed to promote plans for health care but there was more hope than result. The law was lacking in enforcement power and local health planning groups spent enormous quantities of time presiding over local political issues.

Regionalization of perinatal care can be traced to the development of premature infant centers in the United States during the 1930's and 1940's. While the premature infant centers spread throughout the country during this period, there was little in the way of standards of perinatal practice as we know it and the impact of the centers on infant morality in the U.S. was modest.

An authoritative publication on regionalization from a Columbia University symposium in 1977 failed to mention regional perinatal care. Perhaps this "oversight" was a fair comment on the low priority given the perinatal care movement by the professionals in the health planning field.[1]

Many of the past efforts to establish regional programs to improve access to care, to increase the number of physicians or to relocate professionals, etc. have been federally funded. Regional perinatal care programs attracted some demonstration funds, such as Fund B programs from the Children's Bureau but the bulk of support, stalling and systems development came from diverse sources. Public, private and voluntary funds flowed through a pluralistic network of agencies, institutions and organizations in a disjointed and uneven approach. Perhaps that diversification of program funding and direction was a strength that carried regional perinatal programs forward.

There have been positive consequences of regionalization on neonatal outcome. While the improvement of the outcome of pregnancy is the major goal, regional perinatal education, expanded role of nursing, interhospital care, shared services and systems development can be identified as well as benefitting from the macro concept of regionalization.

At the national level, the infant mortality rate (IMR) position of the U.S. among industrialized nations had been a nagging embarrassment. From 1950 to 1965 the IMR remained almost static at 25/1000. In the next 15 years, as regional perinatal care developed in most regions of the country, the IMR fell by 50% to a record low of 13/1000 in 1979. Most of that improvement has been for newborns in the first month of life as all but 15 states reported neonatal mortality rates (NMR) less than 10/1000 in 1978.[3]

It is impossible to explicate every factor in the improved outcome of newborns in the U.S.A. and dangerous to attribute any single factor as the reason for the trend.[4,5] It is my belief, though, that the regionalization of care has been one of the most important of these factors.

In this welcome opportunity to track a few forces in the regionalization movement, I have taken an eclectic approach which is both a personal commentary as well as a citation of several seemingly unrelated events of that last quarter century that have converged in this effective arrangement of perinatal care.

TWENTY-FIVE YEARS IN THE WINGS

"Bystanders have no history of their own . . . But standing in the wings -- much like the fireman in the theater -- the bystander sees things neither actor nor audience notices."

-- Peter F. Drucker

Since that day in 1956 when I stood next to Drs. C. Henry Kempe and Frank Cozzctto at the incubator of a dying premature infant at Children's Hospital in Denver, I have been thrilled at being a bystander in the evolution of regional perinatal care in America. From 1951 to 1955 at the University of Colorado School of Medicine and in 1955-56 as a rotating intern at San Francisco Hospital, the premature infants that I encountered as a medical student, intern and subsequently as a pediatric resident presented a monumental challenge. At the Premature Infant Center of Colorado General I Hospital Dr. Lula Lubchneco was the director of my fellowship from 1956 through 1958. Earlier studies of the premature infant by Dr. Lubchenco and her mentor, Dr. Harry Gordon, with Dr. Samuel Levine had shifted the management of the premature infant from custodial care-taking to scientific-based concepts of care. The collaboration of Stewart Taylor, Professor and Chairman of the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine and his pediatric: counterpart, Dr. Harry Gordon, in 1947, established the premature infant center of Colorado General Hospital as a western landmark in the history of premature infant care in the United States.

Others will tell of the epic travels of Martin Couney and his influence on Dr. Julius Hess in the "White City" era of Chicago. Various other authors will make their- case for being the first or the finest of chapters in the premie story. And each bystander has his own academic heroes. So be it.

I bring my story as a bystander back to the University of Colorado and the premie center where Dr. Donough O'Brien unwittingly struck the spark of my interest in regionalization of perinatal care.

During some casual exchange on rounds, Dr. O'Brien set my mind in motion. We were talking about nutrition and he made the offhand remark that one would never solve the problems of hunger in underdeveloped nations by providing a few more meals. It was a social, economic and political matter if there was ever to be progress in solving the root issues of malnutrition Against that matrix of forces that could impact on the outcome of premature infants, the generalization of a systems approach emerged.

I transposed that thought to the case of the premature infant in particular and sick newborns in general. It was a unifying theoretical approach to the problems of excess perinatal mortality and related morbidity. By adding an organizational dimension, the possibility and the logic of regional perinatal care came into focus for me.

During two years as a fellow and five years as junior facility at the University of Colorado Medical Center (UCMC), my interests in premature infant care turned to a community outreach style. Two events strengthened that concept.

One was my appointment as captain of the UCMC United Way Fund Drive and the other was a referral of a tiny baby from Monte Vista, Colorado -- 167 miles southwest of Denver.

The experience with the United Way Fund Drive opened my eyes to the many agencies in the community that serve people in need. The Monte Vista baby led to our first air transport using an Air National Guard DC-3 to move a three-pound baby to Denver. Needless to say, the logistics were mammoth; but the model was exciting.

When Children's Hospital, Denver, decided to open a facility for premature infants in 1965, 1 was appointed Director of the Newborn Center. As the name implies, my immediate commitment was to sick newborns on a regional basis but with a perinatal orientation as a long-term goal.

That thesis had been put into action in 1963 when Dr. Joe Brazie and I hosted the Aspen Conference on Perinatal Biology with a grant from Mead Johnson Nutritional Division. The following invitees took part: Marvin Cornblath (Chicago), Jerold Lucey (Burlington), Thomas K. Oliver, Jr. (Columbus), Charles H. Bauer (New York), John Boehm (Lexington), Robert Schwartz (Cleveland), J. Rodman Seely (Oklahoma City), Sydney Segal (Vancouver), Mildred Stahlman (Nashville), the late Helen Reardon (Philadelphia), plus Joseph Brazie, Lula Lubchenco, Donough O'Brien and me from Denver.

The absence of obstetricians was only too obvious as was the general perinatal approach at that time. Clearly neonatal people were leading the way. Four years before (1959), Drs. C. Henry Kempe and E. Stewart Taylor hosted a conference at the Brown Palace Hotel in Denver. The pediatric and obstetric directors of premature infant centers from throughout the United States were invited to participate. As an impressionable fellow at the time, it was disturbing to observe how little interaction had taken place between the pediatric and obstetric leadership. Unfortunately, the proceedings of that landmark conference were not successfully recorded for posterity. For sure, my role at the conference was as a bystander on the way to the stage.

The quarter century from 1956 to 1981 has included more progress and more promise for the premature infant than any similar quantum of previous time. Not only has the technology and treatment ascended in quantity and quality but the kinship of psychological and sociological programs has brought a kind of completeness to the story of premature infant care. It would be a disservice to ignore these soft dimensions of regionalization in the discussion of outcomes. The follow-up studies of Lubchenco[7] and others put in perspective the important question of the quality of the survivors of intensive care.

As Drucker so aptly put it, "the bystander reflects -- and reflection is a prism rather than a mirror; it refracts. "[8]

THE REGIONALIZATION OF AMERICA

Eli Ginsberg defined regionalization as "a form of resource allocation or service delivery rooted in geography." In the introduction to Regionalization and Health Policy, Ginsberg cites the resources in the present health system that might be responsive to political and consumer pressures, to improve access to more cost-efficient and care-effective health services. Physician distribution, capital expenditures and patient flow were integral elements in this thesis that regionalization "should be able to yield greater social benefits to more citizens through improved allocation and use of resources than is now the case." According to Ginsberg there are crucial considerations if regionalization is to work . . . "A mechanism must exist that assesses the health needs of a population within a defined area and responds by altering the existing resources and/or adjusting the supplies of health personnel, facilities, and equipment."[9]

The establishment of the first premature infant center at Sarah Morris Hospital in Chicago in 1923 marked a new era in concern for the sick newborn.[10] The work of Dr. Julius Hess and Miss Evelyn Lundeen, RN, became the guidebook for "premie" care as other centers were developed in the United States. Dr. Louis Gluck established the first newborn center in the country at Grace New Haven Hospital in 1960.[11] These hospital components of regional perinatal care have grown to nearly 350 intensive care centers in twenty years.[12] Each regional center has developed a set of outreach tools in the shape of transport systems, outreach education programs and funding mechanisms that are modern day expressions of American creativity.

The Newborn Center of Children's Hospital in Denver opened on February 1, 1965 with a commitment to providing a comprehensive newborn intensive care service on a referral basis for hospitals in the Rocky Mountain and Great Plains region. From the onset, the operating philosophy was to develop programs and policies to improve the outcome of pregnancy on a local, regional and national basis. The national events are cited, since they shaped a national policy in the United States.

In 1966, the Ross Conference on Intrauterine Transfusion was held in Aspen with joint sponsorship by the University of Vermont and the Children's Hospital, Denver. The site and style of this conference were extensions of the 1963 Aspen Conference on Perinatal Biology which resumed as the Aspen Conference on the Newborn in 1967.

At the regional level, service, education, communication and transport systems were developed to combat the excessive neonatal mortality of the sixties. Colorado ranked #45 in neonatal mortality rate in 1960. Only five states had a higher neonatal mortality rate (in 1978 Colorado ranked #2).

In the mid-sixties, an exchange of perinatal educational programs centering on the football rivalry of Colorado and Nebraska brought attention to the Newborn Center by the late Dr. Harold S. Morgan, a member of the AMA Committee on Maternal and Child Care (CMCC).

In 1969, I was appointed to the AMA Committee on Maternal and Child Care which was chaired by Dr. Sprague Gardiner. In March, 1970, 1 was guest of the Committee of the Fetus and Newborn of the Canadian Pediatric Society which had developed, in cooperation with the Society of Obstetrics and Gynecology of Canada, an excellent statement on regional perinatal care.[13]

Armed with that articulation of a policy statement from Canada and fresh with enthusiasm for regionalization based on a young working model in Colorado, the author introduced the concept of regional perinatal care to the AMA Committee on Maternal and Child Care in Chicago, in May 1970. A subcommittee was charged with developing a policy statement that would be presented to the Board of Trustees and the House of Delegates.

In October of 1970, the ad hoc committee of Jerold Lucey, Belton Meyer, Leo Stern, L. Joseph Butterfield, and Sprague Gardiner met at the Brown Palace Hotel in Denver. In two days, the group composed a policy statement on regionalization and/or centralization of perinatal care. The policy statement was revised at the winter and spring meetings of the CMCC and adopted at their meeting in Litchfield Park, Arizona in April, 1971.

After review and endorsment by the AMA Board of Trustees, the policy statement was considered by the AMA House of Delegates in August of 1971 and adopted as AMA policy! This was a landmark day in American medicine and a futuristic statement on perinatal medicine by the AMA.

The policy was transmitted to the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and the American College of Obstetricians and Gynecologists (ACOG) for their endorsement and support. Over the next two years each organization reviewed the policy and supported it with various degrees of enthusiasm depending on the mix of concerns in their membership.

In the Spring of 1972, a sequence of events took place that led to a unique coalition of representatives of four national professional organizations and a national voluntary organization.

At the March, 1972, AMA Conference on the Quality of Life, in Chicago, Dr. Arthur Salisbury from the National Foundation/March of Dimes (NF/MOD) expressed his concern to me that the AMA policy statement on regional perinatal care had stimulated many hospitals to enter the neonatal care business without consideration of a regional plan. There was definitely a need for guidelines or standards for levels of perinatal care.

In April of 1972, the Spring session of the AAP was held in San Diego where Dr. Stanley Harrison and I from AAP and Dr. Virginia Apgar, Dr. Arthur Salisbury and Mr. Gabriel Stickel from the NF/MOD held an informal discussion of the feasibility of national guidelines for regional perinatal care under the auspices of the four organizations concerned.

I relayed that interest to Dr. Sprague Gardiner in Chicago, on May 2, 1972, the day before he was installed as president of ACOG. Dr. Gardiner thought long and hard on the possibility of a national consortium charged with the development of guidelines for perinatal care as a way of implementing the 1971 AMA policy. He made two critical decisions that, no doubt, have had crucial long term impact. First, he stated his belief that the professions that provide the bulk of perinatal care should take the leadership in any guideline development and he made it clear that the professions should take the initiative in inviting other parties to collaborate. He agreed to call a special meeting of the leadership of the four major provider organizations during the AMA annual meeting in San Francisco. But he had already made up his mind that the NF/MOD should be invited to join forces with the representatives of AMA, AAP, AAFP and ACOG whenever a task force was formed.

In June of 1972, Dr. Gardiner presided over a congenial breakfast meeting at the Hilton Hotel. Dr. John Kernodle, Chairman of the Board of Trustees of AMA, Dr. Jay Arena, President of AAP, Dr. Robert Quello, Treasurer of AAFP and members of the AMA Committee on Maternal and Child Care took part in the discussion. The adoption of the policy on regionalization by the AMA House of Delegates the preceding summer had given the AMA Board of Directors a pride of leadership in maternal and child health. The AAP, AAFP and ACOG leaders were in agreement that the time was ripe for an ad hoc group to convene to accept the task of implementing that landmark policy. And so, over coffee and croissants, it was agreed to agree.

August, 1972: Following discussions between Dr. Gardiner and NF/MOD officers and staff, a meeting at the O'Hare Marriot Hotel in Chicago was set. The participants were addressed by the host, Mr. Harry Green, Chairman of the Board of Trustees of the NF/MOD. The following day a planning meeting was held and task forces were appointed. Participants in the meeting included Drs. L. Stanley James (AAP), L. Joseph Butterfield (AMA), George Ryan (ACOG) and Robert Quello (AAFP); they, the Committee on Perinatal Health and the following were assigned to task forces on facilities and services: Jack G. Phipps and Keith P. Russell with Alfred Hicks II, Jean D. Lancaster, Arthur J. Lesser, H. Belton Meyer, Richard Paul, Jack M. Schneider and Leo Stern serving as facilities and services consultants. The personnel task force was composed of Drs. Stanley N. Graven, Charles E. Gibbs, Robert E. Heerens and Ervin E. Nichols, with Dorothea Lang, Beverly Aure, Susan Hershberger, Katherine Kendall, Mildred Quinn, Bradley E. Smith, Mary Southerland and Donald Walker serving as personnel consultants. The task force on implementation and financing consisted of William C. Ellis and Raymond Jennett while Ronald M. Klar, William Lowery and Lester 1. Tenney served as consultants. National Foundation Staff included Arthur J. Salisbury and Gabriel Stickle.

It was no coincidence that Dr. Gardiner had been elected Chairman of the Committee on Perinatal Health. His clinical savvy, his keen organizational skills and his uncanny political sense made him an ideal leader for the campaign that had begun to improve the outcome of pregnancy.

After four years, the report of the committee was published by NF/MOD in 1976. "Toward Improving the Outcome of Pregnancy" (TIOP) was the synthesis of professional organizations and consultants through a working set of broad-based guidelines. The monograph evoked enormous interest and was quoted extensively in the generation of state, regional, and national health policies. In the Standards for Obstetric and Newborn Services, which was published in the March 28, 1978 Federal Register, TIOP was quoted widely in national recognition of that publication, of which 50,000 copies have been circulated.[14] During the seventies, the elements of regional perinatal care were being stated, developed and put into practice throughout the United States.

In 1973, the 66th Ross Conference on Pediatric Research was held at Litchfield Park, Arizona under the auspices of the Department of Pediatrics, Stanford University School of Medicine, and the Department of Obstetrics and Gynecology, University of Southerrn California. Drs. Philip Sunshine and Edward J. Quilligan served as co-chairmen.

In his editorial note, Dr. Sunshine cited the "great impetus ... to establish regional centers to care for high-risk mothers and their infants." The first portion of the conference was given to discussion of model programs such as those in Wisconsin, North Dakota, Mississippi, Massachusetts, California, New Jersey, Arizona, Colorado and New York. Those examples of city, state and regional programs and the essential components of personnel, instrumentation technology and systems of maternal and neonatal transport provided a major reference to developing programs.

By coincidence, the AMA Committee on Maternal and Child Care met in the same hotel in 1970 to approve the final draft of the "Statement on Centralized Community or Regionalized Perinatal Intensive Care" which was included as an epilogue to the Ross Conference report.[15]

On April 9, 1981, the Section on Perinatal Pediatrics of the AAP took time at the plenary session of the AAP annual meeting to recognize Dr. Sprague Gardiner "for his leadership in the implementation of the policy of regional perinatal care as adopted by the AMA House of Delegates in 1971."

It was an incredible decade for maternal and newborn care.

STATEWIDE PERINATAL PROGRAMS

In 1974, Berger conducted a survey of regionalized perinatal care in the United States. In 28 states, perinatal programs were reported to be operational-only 15 on a statewide basis. As a measure of the popularity of regional perinatal health services, only four states reported no plan for regionalization of perinatal care by 1976.[15]

Reference was made to the 66th Ross Conference on Pediatric Research: Regionalization of Perinatal Care. (For the details of existing programs see reference 16.)

Berger, et al., pointed out the lack of published information on the impact of regionalization on outcome and the hazards in attributing declining neonatal mortality to new programs. Since the sixties, neonatal mortality rates have declined steadily in the United States.

The Quebec experience with premature infant mortality was an early signal of the hope for regional perinatal care. With large numbers recorded by the Province of Quebec, the Perinatal Mortality Committee reported on perinatal mortality rates for hospitals with intramural Neonatal Intensive Care Units (NICU), hospitals without an NICU but which regularly transported sick babies to a regional NICU, and hospitals that neither had an NICU nor utilized a regional center. The lowest neonatal mortality was in those hospitals with an NICU; the highest in the non-NICU hospitals which did not refer to a regional center.[17,18]

In North Carolina, the authorizing legislation that funded the Regional Perinatal Care Programs mandated evaluation of the program. The evaluation plan was designed to determine whether or not changes in perinatal mortality and morbidity were related to the program. Since the North Carolina program of evaluation used a central population, the results of that experience will be of interest to health planners and fiscal watchdogs in the 80's.

Approximately ten years after the Massachusetts Department of Public Health adopted regulations for premature infant care that left the option of continuing obstetric services up to the hospitals, about half of the obstetric services in the state closed.[19]

Ryan utilized a process rather than an outcome audit to measure the impact of regional planning of perinatal care in Massachusetts.[20] A questionnaire was designed to evaluate changes in such regional planning issues as facilities and services, referral patterns and availability of educational programs. The survey of 505 fellows of the American College of Obstetrics and Gynecology in the State of Massachusetts elicited 47% (235) response. There was better or improved coordination of facilities, better fetal monitoring, improved facilities or equipment, and better trained obstetric nursing personnel. Obstetric anesthesia improvement was less frequent with more negative responses to the questionnaire.

The authors concluded that changes in the patterns of perinatal care supported by professional leadership are consistent with the goals of regional planners.

The organization of perinatal care in Colorado followed rather opportunistic pathways in the late sixties and seventies. The premature infant center at the University of Colordo Health Sciences Center shifted toward a regional perinatal policy; the newborn center at Children's Hospital came on the scene as regional perinatal care was entering a logarithmic phase of growth and both local and national forces were shaping the health plan.

Colorado has the advantage of only one medical school. With one faculty of pediatrics and obstetrics, the opportunity to cooperate in academic activity has a spinoff in the design and operation of clinical facilities. Another advantage in the process was the lack of a single source of funding which allowed a measure of fiscal flexibility.

Cooperation took a positive turn in 1971 when Dr. C. Henry Kempe, then chairman of the Department of Pediatrics at the University of Colorado Medical Center, stimulated a sharing of referrals of sick newborns between Children's Hospital and the University of Colorado Medical Center which led to an exchange of faculty from the Division of Perinatal Medicine for teaching. From that time onward, Children's Hospital and the University of Colorado Medical Center, along with Denver General Hospital and Fitzsimons Army Medical Center, formed an informal perinatal center for the region-a perinatal conglomerate without an organizational table.[21]

These four level III neonatal intensive care units have been increasingly recognized by the referring physicians and the agencies in the region as a multi-roof perinatal center. When space was unavailable in one hospital the patients were "shunted" to the hospital with the open beds. More than anything else this statement of a single perinatal resource in the region has offset competitive activities and placed patient care needs before hospital egos. One example that attracted global interest was the transfer of a mother with sextuplets from Rose Medical Center to the University of Colorado Health Sciences Center. Staff from several centers participated in the complex delivery of six premature infants.

Level II nursery units were developed at Rose Medical Center, St. Joseph Hospital, St. Luke's Hospital, Lutheran Medical Center, and Swedish Medical Center in metropolitan Denver and in Colorado Springs, Durango, Fort Collins, Grand Junction, Greeley, and Pueblo, according to guidelines of the Colorado Perinatal Care Council.[22]

As one result of the improved access to quality perinatal care, 84% of the newborns who died in 1978 died in a level III or level II NICU.

The outreach educational activities of the Children's Hospital and the University of Colorado Health Sciences Center are frequently combined and staff from level II and level III hospitals are utilized in teaching. This demonstration of cooperation in the field is further evidence of a cooperative system. The teaching protocols and transport procedures are unified and consistent in content.

Staffing of the level III and level II NICU has been improved through a quarterly course in basic perinatal principles that is coordinated by a Children's Hospital nurse coordinator with support by the Colorado Department of Health, Division of Maternal and Child Health. The 40 hour, ten-week course is open to RN's and LPN's from the regional hospitals at a modest fee. The curriculum book is prepared by nurses and physicians from the Denver hospitals and reflects a common basis for newborn care.

Children's Hospital and University of Colorado Health Sciences Center have had a combined pediatric training program since 1972. PL I, II and III residents rotate to the nurseries at Children's Hospital, Denver General Hospital, Rose Medical Center, and University Hospital. Fitzsimons Army Medical Center (FAMC) has a separate pediatric training program. Fellows based at University Hospital and at Children's Hospital are from the combined program. Fitzsimons Army Medical Center fellows rotate to Children's Hospital and Children's Hospital fellows rotate to St. Luke's Hospital. This mix of resident, fellow, and hospital staff is essential in maintaining a Regional Perinatal Center of several hospitals if for no other reason than keeping the communication channels open.

OUTREACH EDUCATION AND MARKETING

From 1974 through 1978 the National Foundation/March of Dimes (now March of Dimes Birth Defects Foundation) provided grant funds for regional perinatal outreach education. In cooperation with the University of Colorado Health Sciences Center, teams of nurses, physicians, respiratory therapists and social workers in various combinations participated in "the tour." A unified presentation was made in conferences, site visits, and consultations that focused on early recognition of the high-risk mother and/or baby plus stabilization procedures, care plans that included transport of mother or baby and family support programs.

Cooperation by staff at the tertiary level hospitals and the secondary level hospitals was encouraged in actual practice and taught to medical and nursing personnel. Whenever possible, administration, board members and local media were included so that the regionalization process was not perceived as a purely medical issue.[23]

In addition to outreach nurses, respiratory therapists and physicians from the region were invited to spend short-term training experiences in the level II and level III hospitals in Denver.

The use of the health marketing theme "Newborn Country USA" helped describe a region, an interdependence, and a system of informal to formal arrangements for improving the outcome of pregnancy. The Newborn Country theme also deemphasized the hospital basis of regionalization and emphasized the regionwide health care system. As was observed about the railroads that got into trouble because they forgot they were in the transportation industry, so the hospitals should remember that they are in the health industry.

In addition to March of Dimes Birth Defects Foundation support, the Colorado Department of Health, Divisions of Maternal and Child Health and Emergency Medical Services gave contract money in support of the Newborn Emergency Service and the Perinatal Outreach Education Program.

The American Lung Association of "Colorado began to include "young lung" programs in their professional services in 1976, and a private voluntary effort called "November Noel" raises money through fashion luncheons to support research and physician-nurse education programs at Children's Hospital and in Colorado Springs hospitals.

Significant support for outreach activity has also come from a family foundation and anonymous donors.

ROBERT WOOD JOHNSON FOUNDATION

The Robert Wood Johnson Foundation funded eight perinatal centers in 1975 to stimulate development of regional perinatal programs and the evaluation of their effectiveness. A population of nearly 20,000,000 people in rural, suburban, and urban communities was included in this major test of the practicality of regional perinatal care. In addition to generating data on perinatal outcome in a rational system of perinatal services, the experience of the Robert Wood Johnson (RWJ) experiment will have an impact on future guidelines and provide a test of the regionalized approach to perinatal health care in the United States.

Merkatz describes one of the program models. His closing comments in 1976 are just as compelling in 1981:

"Regionalization brings the promise of a rational system of allocating resources to the benefit of each individual patient: It avoids the fortuitous and sometimes haphazard manner in which patients' needs and the health system interface. Responsibility is thus shared and the specialized facilities become more available to both physicians and patients. Whether the pluralism of United States health care can accommodate such a concept remains a moot question."[24]

In 1980, Shapiro et al. examined the question of the relevance of death risks with morbidity risks, since one concern among skeptics of regional perinatal care programs is that lower mortality rates will be followed by higher levels of morbidity in the survivors.

In a random sample of nearly 5,000 infants born in 1976 that were evaluated for maternal history and outcome of the child, 14% of less than 1500 gram single live birth babies were severely impaired, compared with 1.6% of greater than 2500 gram infants. Overall, 28% of the sample of infants had various degrees of morbidity. The authors contrast this approach with their broader base of health problems to previous studies that have used death or specific conditions as a variable.[25]

Similar samples of the outcome of the births in the eight centers may reveal that as perinatal care and outcome improve so will morbidity be lessened. Since that is the crux of the concern about intervention, further reports by Shapiro, et al. will be anxiously awaited.

HAS REGIONALIZATION IMPROVED OUTCOME?

Four reports from Colorado reflect the improved pregnancy outcome that has been coincident with 1) regionalized perinatal care, 2) outreach education for nurses and physicians, 3) establishment of a Colorado Perinatal Care Council, 4) modern transport systems for mothers and newborns, 5) increased maternal transport to level II and level III perinatal centers, 6) increased public awareness that high risk pregnancy outcome care be improved with modern perinatal medicine techniques, etc.

Between January 1974 and June 1975 the neonatal intensive care unit at Fitzsimons Army Medical Center received 31 neonatal and 31 antenatal referrals from two local military hospitals which had a combined total of 2051 deliveries during the study period.

The 62 neonatal and antenatal referrals to FAMC, a level III perinatal center, were compared by birth weight, gestational age and outcome. There was a significantly lower than predicted neonatal mortality rate and a shorter hospital stay in the 31 antenatal referrals.[26]

McCarthy and Butterfield studied neonatal mortality for all live births in Colorado from 1971 through 1976. The years 1972-73 and 1974-76 were compared since the second era coincides with the increase in regionalization activity in the state. Live births by county of residence were sorted according to the highest level of neonatal intensive care accessible in that county, using the standards for level I, II and III nurseries as generally accepted.

NMR declined by 35% during the second era and the percentage of decrease was proportional to the lack of available services. That is, the greatest decline in NMR was in the nineteen counties with no institutional services for mothers and newborns. The least decline in NMR was in the single county (Denver) with level III NICU services.

When the NMR in 1977 was received by aggregates of counties, none of which had level I, II or III services, there was no difference in NMR between the aggregates of counties, each having a NMR of 8/1000 live births. Although this study suffers from lack of control populations, it suggests that the entire population of the state was finding access into a system of health care that resulted in neonatal mortality rate parity.[23]

At the University Hospital, from 1975 through 1976, Bowes, Halgrimson and Simmons offered intensive perinatal care to all mothers who were expected to deliver a baby weighing 600 grams or more. Coincident with that change in management of high risk mothers, the NMR for <1500 gram babies dropped from 60% for the 1958-68 and 54% for the 1971-74 periods to 32% for the time of the study.[27] In the four years after the study the NMR has remained in the lower range although the precise management techniques are more subject to wider variations in attending physicians' style of practice.

To attempt to examine the merits of being born in such an environment versus being born in a community hospital and transported to an intensive care unit at a second hospital, Lubchenco et al. studied 694 <1500 gram infants who were born in metropolitan Denver within a 20 minute radius of a level III NICU in Denver.

Between 1974 and 1979 Lubchenco et al. compared the outcome of 301 <1500 gram infants born in five metro Denver hospitals (MDH) with 393 <1500 gram infants born in the University Hospital (UH). The MDH babies were transported to level III nurseries at Children's Hospital, Fitzsimons Army Medical Center, Denver General Hospital, or University Hospital. The metro Denver hospitals' nurseries were considered level I during the comparison period.

Fetal deaths were twice as frequent in MDH population (25% vs. 12.5% p <0.01) but neonatal deaths were not significantly different in the two groups (37% in the MDH; 30% in the UH). Infant deaths were 3% and 4% respectively in the MDH and UH groups.

At 12 to 24 months, there was no difference in the development outcome of the two groups.

Since 61% of the UH group were in utero-transported babies, that population was separated and reviewed. Fetal deaths were 9.5% and neonatal deaths were also less (27%).

This led the authors to conclude that the MDH and the UH populations were dissimilar. The small but nonsignificant neonatal mortality rate in the MDH and UH groups suggests that the capability of first hours care in the MDH and the interhospital phase of care (transport) was not prejudicial to outcome in the short term nor up to 24 months of age .[28]

Several of the abstracts submitted to the 1981 American Pediatric Society and Society for Pediatric Research meetings reflected regionalization issues. [29-33]

Ahn and Ferrara found that mortality of transported infants on weekends was significantly increased despite lower utilization of the transport service on Saturdays and Sundays .29

Cordero studied the effect of birthplace on the outcome of 500-1250 gram infants for three years in a county population. The mortality rate of babies transported to the Regional Perinatal Center was 51% compared to 77% for those kept at community hospitals (p < 0.01).[30]

Hirata reported on 56 infants weighing 520-750 grams of whom 34 were outborn and 22 were inborn at Children's Hospital, San Francisco. Survival was 41% in the outborn and 36% in the inborn low birth weight babies. The mean IQ of the 5 inborn survivors was 96 ± 12 while that of the 9 outborn survivors was 70 +/- 21. The conclusion was that "high risk mothers should be transferred to a tertiary center and meticulous perinatal management instituted because the <750 gram infant is not `too small.' "

Spitzer evaluated outborn and inborn RDS (Respiratory Distress Syndrome) babies and found that the course of RDS in inborn babies was different:

Wirth compared the clinical course of 50 matched pairs of NICU babies for maternal complications and the outcome of the babies. While the C-section rate, Apgar score, RLF (retrolental fibroplasia), BPD (biparietal diameter), IVH (intra-ventricular hemorrhage), NEC (necrotizing enterocolitis), time on ventilator, and ALOS (average length of stay) were not different, the perinatal center-born babies had significantly less cold stress and neonatal mortality. Transported babies had lower mortality than nontransported babies.[33]

Schneider states a strong case for the positive impact of regional perinatal care on perinatal outcome and gives credit to various professional organizations and the pluralism of the American way in health.[34]

Parenthetically, in his editorial on the steep decline in infant mortality in the United States to below 13/1000 in 1980, Shapiro is cautious in giving credit to several changes that occurred during the preceding 15 years. Regionalization of perinatal care is but one of a number of forces that may be shaping childbirth American style. Although the energy behind many of our regional programs has drawn on that possibility, we should maintain a degree of decorum until studies such as a those soon to be reported from the Robert Wood Johnson Foundation perinatal program give us genuine cause to celebrate a new era in perinatal medicine that gives regionalization its due credit.

REFERENCES

1. Lewis C. E.: Improved access through regionalization. Regionalization and Health Policy, 71-84, DHEW Publication No. (HRA) 77-623, 1977.

2. Diamond E. G.: "RMP as I knew him: The rise and fall of an idea." N. Engl. J. Med. 290:1256-58, 1974.

3. Reinhold R.: Care of newborns improves, but high-risk births persist. The New York Times, December 28, 1980.

4. Shapiro S.: New reductions in infant mortality: The challenge of low birth weight. Am. J. Public Health 71:365-366. 1981.

5. Editorial: The price of perinatal neglect. The Lancet, 437-438, 1974.

6. Korones S. B.: On the totality of perinatal care and the role of perinatal social work. Perinatol. Neonatol. 11 and 66, March/April 1981.

7. Lubchenco L. O.: Sequelae of neonatal birth: Evaluation of neonatal infants of low birth weight at 10 years of age. Am. J. Dis. Child. 106:101-115, 1963.

8. Drucker P. F.: Adventures of a Bystander. New York: Harper and Row, 1977.

9. Ginsburg E.: The many meanings of regionalization in health. Regionalization and Health Policy, DHEW Publication No. (HRA) 77-623, 1977.

10. Hess J. H., Lundeen, E. C.: The Premature Infant-Its Medical and Nursing Care. Philadelphia: J. B. Lippincott Co., 1941.

11. Gluck L.: Why P/N? Perinatol. Neonatal. 8 and 52, July/August 1977.

12. Basler, D.: 1982 Guide to Centers Providing Perinatal Neonatal and Special Care. Ross Planning Associates, Ross Laboratories, September 1982.

13. Swyer P.: The regional organization of special care for the neonate. Pediatr. Clin. North Am. 17:761-776, 1970.

14. Toward Improving the Outcome of Pregnancy, Recommendations for the Regional Development of Maternal and Perinatal Health Services. Committee on Perinatal Health, National Foundation March of Dimes, 1976.

15. Berger G. S., Gillings D. B., Siegel E.: The evaluation of regionalized perinatal health care programs. Am. J. Obstet. Gynecol. 125:929-932, 1976.

16. Sunshine P., Quilligan E.: Regionalization of Perinatal Care, Report of the Sixty-sixth Ross Conference on Pediatric Research. Columbus, Ohio, 1974.

17. Quebec Perinatal Committee: Perinatal intensive care after integration of obsterical services in Quebec. Ministry of Social Affairs, Quebec, July 1973.

18. Usher R. H.: The role of the neonatologist. Pediatr. Clin. North Am. 17:199-202, 1970.

19. Donahue C. L. Jr., Pettigrew A. H., Young K., et al.: The closure of maternity services in Massachusetts: The causes, process, and hospital impact. Obstet. Gynecol. 50: 280,1977.

20. Ryan G. M., Fielden J. G.: The impact of regionalization programs on patterns of perinatal care. Obstet. Gynecol. 53:187-189, 1979.

21. Butterfield L. J.: Newborn Country USA. Clin. Perinatol. 3:281-295, 1976.

22. Merenstein G. M. and Butterfield L. J.: The Colorado Perinatal Care Council Sixth Annual Conference on Neonatal Perinatal Medicine. Boise, Idaho, June 5, 1981.

23. McCarthy J. T. and Butterfield L. J.: Newborn Country USA revisited. Rocky Mt. Med. J. 75:208-211, 1978.

24. Merkatz 1. R. and Johnson K. G.: Regionalization of perinatal care for the United States. Clin. Perinatol. 3: 271-175, 1976.

25. Shapiro S., McCormick M. C., Starfield B. H. et al.: Relevance of correlates of infant deaths for significant morbidity at 1 year. Am. J. Obstet. Gynecol. 136:363-373, 1980.

26. Merenstein G. B., Pettitt G., Woodall J. et al.: An Analysis of Air Transport Results in the Sick Newborn. Am. J. Obstet. Gynecol. 128:520-525, 1979.

27. Bowes W. A., Halgrimson M., Simmons M. A.: Results of the intensive perinatal management of very-low-birth-weight infants (501 to 1500 grams). J. Reprod. Med. 23:245-250, 1979.

28. Lubchenco L. O., Butterfield L. J., Black V. D., et al.: Outcome of inborn vs transported high risk infants. Pediatr. Res. 15:670, 1981.

29. Ahn S. S., Ferrara, A.: Correlates of time of utilization of neonatal transport and morbidity outcome, Abs. Pediatr. Res. 15:4, 1981.

30. Cordero L. Jr., Backes, C. R., Zuspan F. P.: Influence of place of birth on the survival of the very low birth weight (VLBW) infant. Ibid.

31. Hirata T.: Improved prognosis of the infant less than 750 gm -- how small is too small? Ibid.

32. Spitzer A. R., Fox W. W., Delivoria-Papadopoulos M.: Respiratory distress syndrome-the perinatal care center versus infant transport in relation to severity of disease. Ibid.

33. Wirth F. H., Wilds P. L., Levy D., et al.: Maternal referral versus neonatal transport to a perinatal center: a comparison between the outcome of matched mothers and their infants. Ibid.

34. Schneider J. M.: Where should preterm labor be conducted? In Elder M. G., Hendricks C. H. (eds.): Obstet. Gynecol. 1. Preterm Labor. Butterworths and Lo Ltd, 1981, pp. 213-230.


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