Keywords
extremely premature infants - practice variation - resuscitation - physician beliefs
- physician religion
Delivery room resuscitation practices of extremely premature infants are not regulated
by professional associations or legal policy. Instead, physicians are given the right
to assess each situation individually and weigh not only the wishes of the parents,
but also the initial clinical assessment of the premature infant and their own judgments
of medical futility.[1]
[2]
[3]
[4]
[5] These factors together dictate the decision of active aggressive resuscitation versus
comfort care. Little is known about the criteria used by physicians to make these
spur-of-the-moment delivery room management plans. Indeed, there is evidence that
prenatal counseling decisions do not always correlate with actual delivery room management.[6] Even less is known about the differences in periviable resuscitation trends among
various institutions in the United States.[7]
[8]
Historically, the social concept of human viability in this country has been closely
tied to legislation pertaining to elective termination of pregnancy. In 1973, the
landmark case of Roe v Wade made it legal for women to seek a termination from a medical professional. At that
time, the United States Supreme Court developed a trimester framework which permitted
abortive procedures after the second trimester only if and when the life or health
of the mother was in jeopardy, implying that a fetus became viable at this time.[9] Almost 20 years later, Planned Parenthood of Southern Pennsylvania v Casey abandoned the trimester model with the opinion of the Court stating, “Whenever viability
may occur, be it at 23–24 weeks, the standard at the time, or earlier, as may be the
standard sometime in the future, the attainment of viability serves as the critical
fact in abortion legislature.”[10]
Among the 50 states and various territories of the United States, legal definitions
of human viability as well as specific statutes regulating termination of pregnancy
vary, with some jurisdictions limiting elective abortive procedures to under 19-week
gestation and others placing no limits until 24-week gestation or more.[11] This, in conjunction with the 2002 Born Alive Infants Protection Act (BAIPA), places
the pediatrician or neonatologist in an often dubious position regarding whether to
attempt resuscitation when faced with the delivery of an infant of 22- to 25-week
gestation, classically perceived to be the “gray-zone” of human viability.[12] Although debatable,[13] most practitioners try to invoke a “best interests” ethical standard to guide them.
However, there are instances when the interests of the parents and the infant may
not coincide,[14] which can make decisions more challenging.
The objective of this study was to delineate any regional variations across the United
States in resuscitation practices of periviable infants and to discern whether or
not these variations are in concordance with individual state abortion limitation
statutes and viability definitions. The study also attempted to ascertain whether
physicians' decisions are more greatly influenced by their personal knowledge of laws
and policies or instead by their own moral values, religious beliefs, or some other
factor.
Methods
A standard survey was sent electronically via the American Academy of Pediatrics (AAP)
to members registered to the AAP Section of Perinatal Medicine in the spring of 2012.
Survey questions included demographics of the respondents such as current location
of practice, location of neonatal medicine training, years in practice, as well as
views on abortion laws, religious affiliations, and knowledge of local legal statutes
and definitions. The entire survey is available as supplementary material in the online
version of this article.
Initial study questions investigated what youngest gestational age providers would
resuscitate if the parents requested and if the parents objected. In addition, respondents
were asked what they considered to be the most important factor in delivery room resuscitation
decisions, as well as if they had ever been required to either resuscitate or not
based on their institution's policy rather than their own clinical judgment.
Subsequent questions assessed the likelihood of delivery room resuscitation given
various clinical scenarios. Scenarios varied on gestational age, weight, sex, and
initial activity exhibited by the infant, as well as on whether the pregnancy was
spontaneous or a product of in vitro fertilization and whether the parents desired
the infant to be resuscitated or not. Respondents were asked to rate the likelihood
that they would resuscitate the infant in each scenario on a scale of “always,” “likely,”
“unsure,” “unlikely,” or “never.” Positive responses were considered to be an “always”
or “likely” response. An additional scenario examined responses of providers if they
were asked to evaluate a fetus after an elective termination of pregnancy for possible
viability and to intervene if they believed intervention to be appropriate. Fetuses
varied on gestational age (22 or 23 wk), weight and movement or respiratory effort.
Responses were extracted to an Excel database (Microsoft, San Francisco, CA). Chi-square
tests, Fisher exact, and multiple logistic regression analysis were done where appropriate
using STATA-12 software (StataCorp LP, College Station, TX). Institutional Review
Board approval was obtained before the implementation of this study.
Results
A total of 758 surveys were returned (30% response rate), of which 637 were complete
and used for analysis ([Table 1]). Majority of respondents were attending physicians, had been in practice for at
least 10 years and had practiced in their current state of employment for more than
5 years. Almost three-quarters identified themselves as Caucasian, approximately 60%
were Christians, and 68% considered themselves to be generally prochoice in regards
to views on elective termination of pregnancy. The proportion of those who worked
in an academic setting versus a community setting was approximately equal. About 70%
of respondents answered that they were both familiar with their local laws limiting
abortion as well as their local state definition of human viability.
Table 1
Measured demographical information of all respondents
Basic demographics (n = 637)
|
Percent (n)
|
Attending
|
91.7 (584)
|
More than 5 y in current state
|
80.8 (515)
|
More than 10 y of practice
|
84.8 (540)
|
50 y or older
|
58.7 (374)
|
Race
|
Caucasian
|
72.8 (464)
|
African-American
|
2 (13)
|
Asian
|
15.5 (99)
|
Hispanic
|
6.3 (40)
|
Other
|
3.3 (21)
|
Religion
|
Catholic
|
25.1 (160)
|
Protestant
|
24.5 (156)
|
Other Christian
|
9.9 (63)
|
Jewish
|
12.4 (79)
|
Muslim
|
2.5 (16)
|
Hindu
|
7.4 (47)
|
Buddhist
|
0.3 (2)
|
Atheist
|
5.2 (33)
|
Agnostic
|
8.3 (53)
|
Other
|
4.4 (28)
|
Active participants in stated religion
|
55.7 (355)
|
Work setting
|
Community
|
46.8 (298)
|
Academic
|
53.2 (339)
|
General abortion opinion
|
Prochoice
|
68.3 (435)
|
Prolife
|
22 (140)
|
Unsure
|
9.7 (62)
|
Familiar with legal definition of human viability in state of employment
|
71 (452)
|
Familiar with legal limit on elective termination in state of employment
|
68.6 (430)
|
Abbreviations: n, number; y, years.
The first question posed was “what is the youngest gestational age at which practitioners
were comfortable attempting full resuscitation, including medications, in the delivery
room if the parents requested?” Answers were distributed in a bell curve between 20
and 26 weeks gestational age ([Fig. 1A]). The majority (68%) of respondents felt comfortable at 23 weeks. This did not vary
statistically when any demographic variables were controlled for using multivariate
logistic regression.
Fig. 1 (A) Youngest gestational age respondents were willing to attempt full resuscitation
in the delivery room, including medications, if requested to do so by the parents.
(B) Youngest gestational age respondents would always attempt resuscitation, even
if the parents objected to them doing so. wk, weeks.
There was statistically significant variation when the country was divided into nine
geographical areas based on the United States Census Bureau ([Fig. 2]). Overall, 23-week gestational age is generally the youngest that neonatologists
are willing to resuscitate in all geographical regions. However, in regards to infants
born at 22-week gestation, there is wide variation in practice. Divisions 1 and 9
reported 0 and 5%, respectively, of respondents willing to attempt resuscitation of
a 22-week infant, while Divisions 4 and 8 showed 19 and 23% of respondents willing
to resuscitate at that gestational age, respectively ([Fig. 3A]). The differences in these two sets of responses were statistically significant
from each other with p < 0.05.
Fig. 2 United States Census Bureau Regional Divisions (2012). Source: https://www.census.gov/geo/maps-data/maps/pdf/reference/us_regdiv.pdf.
Fig. 3 (A) Youngest age providers would resuscitate at parental request, by geographical
location. *, Divisions 1 and 9 significantly less likely to resuscitate a 22-week
infant when compared with Divisions 4 and 8 (p < 0.05). (B) Youngest age providers would resuscitate, even over parental objection,
by geographical location. *, Divisions 1, 8, and 9 significantly less likely to consider
24-week infants should be resuscitated over parental objection compared with Divisions
5, 6, and 7 (p < 0.05).
The same analysis was completed in regards to the youngest age in which practitioners
would resuscitate an infant, even over parental objection. Overall 51% answered that
25 week was the cutoff ([Fig. 1B]). This also did not change after controlling for demographics.
Again, statistically significant variation based on the geographical location was
discovered ([Fig. 3B]). The majority of respondents across the country agreed that at 25-weeks infants
in most situations should be resuscitated; however Divisions 5 through 7, representing
the Deep South and Texas, have many more practitioners who consider 24 weeks to be
obligatory for resuscitation when compared with Divisions 1, 8, and 9.
When respondents' answers for obligatory resuscitation was compared with state laws
regarding specific gestational age limits on elective termination of pregnancy, no
correlation was found to exist. In states where a woman is prohibited from obtaining
an elective abortion after 23 weeks and 6 days gestation, respondents were paradoxically
three-times less likely to consider 24 weeks to be of obligatory resuscitation (12%
of responses) than their counterparts who either practice in a state where a woman
can have an elective termination up until 24 weeks and 6 days (36% of responses) or
whose state legislature contained a more vague cutoff of “third-trimester” (32% of
responses). This was statistically significant (p < 0.05).
In response to the delivery room scenarios, the differences found were similar for
all gestational ages between 22 and 25 weeks, with only the overall proportion of
respondents attempting resuscitation increasing as the gestational age increased ([Fig. 4]). No differences were found in the likelihood of attempted resuscitation based on
infant sex or whether the pregnancy was a result of in vitro fertilization. In contrast,
weight of the infant significantly affected responses, with bigger infants being more
likely to be resuscitated (p < 0.05). Finally, the most significant difference was seen in what the parents' wishes
were. If the parents did not want their baby resuscitated, practitioners were likely
to comply (p < 0.05). Only at 26-week gestation did respondents answer that they would always
or likely resuscitate the infant over 90% of the time in all of these scenarios with
no differences based on the specific variables. Similar to the previous findings,
answers to scenarios did not vary based on the state laws of individual respondents.
Fig. 4 At 22-weeks to 25-weeks, respondents were less likely to answer “always” or “likely”
to attempt resuscitation of smaller infants and infants of parents who do not wish
resuscitation. No differences were found in responses based on sex of infants or mode
of impregnation. 400 g, 400 g birth weight; 750 g, 750 g birth weight; everything,
parents request resuscitation; DNR, parents do not request resuscitation; Spont preg,
naturally conceived pregnancy; IVF, in vitro fertilization. * denotes statistical
significance p < 0.05.
The final set of scenarios involved late elective termination of pregnancy procedures
and asked the respondents the likelihood of attempting to resuscitate the aborted
fetus if they were asked to attend the procedure to evaluate the fetus for potential
viability. Overall most providers would not attempt resuscitation in this circumstance
for a 22- or 23-week fetus, no matter what the weight or whether the fetus exhibited
any spontaneous movement or respiratory effort ([Fig. 5A]). When divided by self-reported religion, results did not vary significantly with
the exception of the 750 g birth weight 23-week fetus that is moving or having some
respiratory effort ([Fig. 5B]). One outlying group was illustrated which was Muslims who considered themselves
active participants in their religion. The number of people in this category was exceedingly
small (n = 11) and so whether or not this represents a true phenomenon is unknown at this
time.
Fig. 5 (A) Respondents answering that they would “always” or “likely” attempt resuscitation
on fetuses in scenarios of elective termination of pregnancy procedures where they
were required to attend to examine the fetus for potential viability. (B) Responses
broken down by self-reported religion. Only respondents who considered themselves
“active participants” in their respective religions are shown. (C) Responses by self-reported
views on termination of pregnancy. 22w, 22-week gestation; 23w, 23-week gestation;
400 g, 400 g birth weight; 750 g, 750 g birth weight; spont move, fetus exhibits some
spontaneous movement and/or respiratory effort at birth; no move, fetus does not exhibit
any spontaneous movement and/or signs of respiratory effort at birth. *, Statistical
significance p < 0.05.
Whether or not practitioners identified themselves as prochoice or prolife did significantly
affect responses in several scenarios ([Fig. 5C]). Neonatologists self-described as prolife were significantly more likely to answer
that they would “always” or “likely” resuscitate larger, moving or attempting to breathe
fetuses following an elective termination of pregnancy when compared with those self-described
as prochoice (p < 0.05). Similar differences between these two groups of respondents were not found
when responses to the premature labor scenarios were compared even when, in those
scenarios, the parents did not wish resuscitation of the premature infant.
Respondents were asked if they had ever resuscitated an infant in objection to their
own beliefs because of either their institution's or practice group's policies; 30%
of providers answered yes to this question.
Finally, respondents were asked to rank, in order, factors that they believe influence
their decision of whether or not to resuscitate a periviable infant in the delivery
room. A total of 33% of providers ranked parental request as the most important factor.
Various categories describing the appearance of the infant in the delivery room, such
as infant birth weight, infant respiratory effort, and physical maturity, collectively
received 38% of respondents choosing these as most important.
Discussion
This is the first study demonstrating geographical variation in current opinions of
neonatal providers with regards to periviable neonatal resuscitation practices within
the United States. While there is a general agreement on resuscitation of infants
of 23 weeks being the youngest age that most providers are willing to attempt resuscitation
on if the parents want it and 25-weeks being the youngest age that most consider should
always be resuscitated even if the parents are opposed to it, the authors found statistically
significant regional variation on resuscitation practices of 22-week gestation infants.
In addition, the southern region of the United States appears to contain many more
providers who believe that infants of 24-week gestation should always be resuscitated,
even if the parents are opposed. Interestingly, this variability is not dictated by
official state legislature pertaining to limits on elective termination of pregnancy
or viability definitions. It also is not dictated by respondent demographics, such
as age, religious affiliation or abortion beliefs, as was demonstrated by multivariate
logistic regression analysis. Instead practice varies by geographical region, elucidating
the possible existence of medical “subcultures” in neonatal practice.
Geographical variation in medical practice is a phenomenon well described in the adult
literature in a variety of conditions, from myocardial infarction to breast-cancer
treatment and cesarean delivery rates.[15]
[16]
[17] More general variation in overall physician expenditure has also been described.[18] Such wide variability fuels the debate over what constitutes usual clinical practice
and what can be perceived to be medically appropriate in any given situation. In the
case of neonatal resuscitation, what is considered acceptable medical practice has
been left to the states and is not consistent, as illustrated in cases such as Miller v HCA
[19] and Montalvo v Borkovecit.[20] It can be argued that such variation in what is judged to be acceptable can be seen
as a violation of the ethical principle of justice when it occurs in the context of
life and death decisions of extremely premature infants. There is ambivalence over
the innate moral value of a preemie,[13] which can partly explain why such variability exists. However, why it seems to be
geographically based is a harder question to answer and requires further research
to tease out underlying themes. Possibilities include how providers are trained, overarching
local philosophies, and also access to resources as well as outcomes data. In regards
to current survival outcomes, while it may be a factor influencing decisions to attempt
resuscitation of extremely premature infants, it must be recognized that this data
are affected by aggressiveness of resuscitation as well as providers' willingness
to withhold or withdraw medical treatments. Therefore, any scrutiny of statistics
related to mortality at the limit of viability should be considered in this context.
The scenario questions illustrate that providers tend to listen to parents and comply
with their wishes through 25-weeks gestational age but not at 26 weeks. When parents'
wishes are not known, practitioners tend to use factors relating to how the baby looks
to guide their decision-making. The findings based on the scenarios questions were
confirmed with 33% of respondents answering that they consider parental wishes to
be the most important factor in the decision to resuscitate in the delivery room and
a cumulative response of 38% specifying that various factors encompassing the idea
of “how the baby looks” to be most important. This echoes the findings of previous
publications.[1]
Overall 19 states within the United States have laws explicitly stating that a second
physician, other than the one doing the procedure, must be present to assess the fetus
for potential viability.[21] These physicians also have the right to intervene and treat the fetus medically
if they deem this action to be appropriate. These laws provided the basis for the
scenarios describing fetuses of elective termination of pregnancy procedures. The
most striking initial result was that 28% of respondents answered that they would
always or likely intervene in the case of a 23-week fetus, 750 g who is showing some
movement or attempts at breathing. When BAIPA was passed by the United States Federal
Government in 2002, it stated that any infant born at any stage in development and
under any circumstance is considered a “person” with protection of the law.[22] This Act, although perceived by some to be nothing more than symbolic of antiabortion
rhetoric,[12] has been used in conjunction with the Emergency Medicine Treatment and Labor Act
to bring about litigation against physicians and hospitals involved with delivery
room management of periviable infants, as was the case in Preston v Meriter Hospital in 2004.[23] In this case, parents sued the hospital where their 23-week 700-g son was born after
premature labor because medical staff did not attempt resuscitation. Although the
AAP has issued statements pertaining to how the BAIPA should or should not affect
practice, it may still have some influence on delivery room care.[24]
[25]
In addition, this particular scenario brings up the widely debated concept of providers'
rights to conscientious objection. For a fetus to be resuscitated following an elective
abortive procedure would constitute a violation of the mother's autonomy, but would
protect the moral rights of the infant, being born alive and no longer a part of its
mother's body, as a sentient member of the human race. Interestingly, survey respondents
who described themselves as “prolife” were significantly more likely to attempt resuscitation
on several fetuses after an elective termination of pregnancy when compared with those
self-described as “prochoice.” When the scenarios describing premature labor were
reviewed such variation did not exist between these two particular groups for any
gestational age, even when the parents did not desire resuscitation. This leads to
the hypothesis that providers' belief systems and/or moral values may play some role
in their clinical practice and delivery room management of specific situations.
In contrast, self-reported religious beliefs did not seem to affect most answers in
regards to any scenarios. The small number of Muslims whom described themselves as
active participants in their religion and took part in this survey were significantly
more likely to resuscitate most fetuses as well as smaller infants in the premature
labor scenarios when those questions were reviewed again. If this indeed represents
a true phenomenon, it would be in concordance with the Islamic concept of human “ensoulment.”
Although there is some disagreement within the Muslim community, many believe that
ensoulment occurs at either 40 or 120 days. Even using the less conservative number,
this means that the fetus possesses a “soul” at approximetly17-week gestation, far
earlier than any of the periviable situations described in this study. In many Muslim
nations, stillbirths after 17-weeks are given proper funerals as any other person
would receive, and fetuses have rights and inheritances granted to other members of
society.[26] There has not yet been any research on periviable delivery practice patterns of
Muslim physicians in the United States and future studies should focus on determining
what these patterns are.
One limitation of this study is that in this setting, hypothetical scenarios can only
be answered to delineate a general sense of existing trends. In clinical practice,
every case that is encountered by providers contains its own nuances and particulars.
A more exhaustive survey could have added innumerable scenarios describing specific
physical findings of the infants, such as fused eyelids, skin translucency, etc. Further
research is needed to address whether the differences found in the survey scenarios
represent actual practice within the United States.
Many ethical debates, such as the moral status of a fetus and a premature infant,
as well as the concept of justice in standardizing medical practice across different
regions of the US, exist in the field of neonatology. While this study cannot provide
answers to these questions, it does provide important empirical data to be used as
evidence in future discourse. Importantly, while the concept of human viability is
constantly evolving, both legal obligations and clinical ethical principles must stay
up to date with contemporary medical practice to be the most effective in guiding
medical staff in these challenging clinical scenarios.