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Journal of Neonatal-Perinatal Medicine 6 (2013) 31–36 DOI 10.3233/NPM-1364412 IOS Press

Original Research

Resuscitation at the limit of viability: Trapped between a rock and a hard place S.B. Bhata , B. Weinbergerb and N.N. Hannac,∗ a Rothman

Institute Department of Orthopaedics, Thomas Jefferson University Hospital, Philadelphia, PA, USA of Neonatology, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA c Division of Neonatology, Winthrop University Hospital, Mineola, NY, USA b Division

Received 15 August 2012 Revised 25 September 2012 Accepted 6 November 2012

Abstract. BACKGROUND: Current professional guidelines, such as the Neonatal Resuscitation Program, specify significant roles for parents in decision-making at periviability. However, current federal regulations and some legal precedents indicate that resuscitation decisions should be made by the physician at the time of delivery, based on physical assessment of the infant. The enforcement of such approach would potentially increase the resuscitation of infants with poor prognoses. OBJECTIVE: To characterize the resuscitation practices of neonatologists attending deliveries of premature infants at the borderline of viability, in the context of current federal legislation. STUDY DESIGN: A questionnaire was administered to directors of all level III neonatal intensive care units in the state of New Jersey, eliciting resuscitation decisions for hypothetical birth scenarios as well as knowledge of legal statutes. RESULTS: Resuscitation decisions for infants born at 24 weeks of gestational age were not associated with parental wishes. In contrast, parental requests were significantly associated with decisions whether to treat infants born at 22 and 23 weeks gestation. Most neonatologists believed they were knowledgeable about federal legislation, but that knowledge did not change the way they practiced. CONCLUSIONS: Our findings suggest that resuscitation of premature infants at 24 weeks gestation is the standard of care in New Jersey, a socioeconomically and ethnically diverse state that may represent broader national trends. The high compliance with parental wishes at 22 or 23 weeks is probably related to physicians’ expectation of poor outcomes at these gestational ages. This approach is consistent with current recommendations of the Neonatal Resuscitation Program but may not be compatible with existing federal statutes and legal precedent. Keywords: Prematurity, resuscitation, viability

1. Introduction The threshold of viability at 22–24 weeks gestation has remained relatively constant over the last two decades [1–3]. As increasing numbers of 22–24 ∗ Corresponding

author: Dr. Nazeeh N. Hanna, Division of Neonatology, Winthrop University Hospital, 259 First Street, Mineola, NY 11501, USA. Tel.: +1 516 663 8450; Fax: +1 516 663 8955; E-mail: [email protected].

week infants are resuscitated, the medical and neurodevelopmental outcomes of such infants have not improved correspondingly [2, 4–6]. Consequently, there has been no consensus on clinical or ethical parameters to guide decision-making at the delivery of premature infants at the limit of viability, and resuscitation practices for these infants are highly inconsistent [7–11]. In the NICHD Neonatal Network between 2003 and 2007, 19%, 68%, and 87%

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of infants were intubated for resuscitation (with overall 6%, 26%, and 55% survival) at 22, 23, and 24 weeks respectively [12]. The NICHD has referred to fetuses at 20–26 weeks gestation, as “periviable, when brief pregnancy prolongation can dramatically alter the potential for survival and long-term complication” [13]. In order to standardize practice and ensure proper care for such newborns and their mothers, there have been significant efforts to codify the limits of viability. Judicial and legislative definitions of viability vary by state. In Miller vs. HCA (2000) [14–18], a Texas court ruled that viability of extremely premature infants is most appropriately determined by physicians after physical assessment, regardless of prenatal expectations or parental wishes. Under the Miller ruling, decisions on resuscitation could only be made at the time of birth after the doctor’s evaluation [19–21]. In 2002, the United States federal government tried to standardize the approach to prematurity via the Born Alive Infant Protection Act (BAIPA). BAIPA states that every child born alive (i.e. “breathes or has a beating heart, pulsation of the umbilical cord, or definite movement of voluntary muscles”) [22] bears intrinsic rights that are not subject to the desires, interests, or convenience of others (including parents) [23]. By providing a blanket clause for all newborns regardless of prognosis or gestational age, the bill effectively resurrected the language of the 1984 “Baby Doe” amendment to the Child Abuse Prevention and Treatment Act (CAPTA) [23, 24], which had been criticized for contributing to the overtreatment of neonates in the face of medical futility. Nevertheless, in 2005, the U.S. Department of Health and Human Services (DHHS) made notification that the agency would utilize BAIPA to enforce “protections” for premature infants through BAIPA’s interaction with the other medical regulatory mechanisms of the Emergency Medical Treatment and Active Labor Act (EMTALA) and CAPTA [23]. Thus, physicians involved in the early care of premature infants are faced with conflicting guidelines and expectations, and practices are highly inconsistent [9, 10, 25]. In this observational, population-based study, we surveyed the directors of all level III neonatal centers in the state of New Jersey to assess delivery room practices at periviability (22–24 weeks gestation), and whether these are affected by expressed parental wishes. Knowledge of BAIPA was also assessed.

2. Methods 2.1. Study design In May and June 2006, a telephone survey was administered to all level III Neonatal Intensive Care Unit (NICU) directors/associate directors in New Jersey (n = 20), using names and phone numbers obtained by contacting each center directly. The list of all level III NICUs was provided by the New Jersey Department of Health. It was assumed that NICU Directors would represent resuscitation practices across their units. The survey was prefaced by a letter to each institute explaining the study and its structural and confidentiality details. Use of a sequential, single call approach by researchers ensured that the names of neonatologists or their respective institutes were at no point associated with responses. Oral informed consent was obtained before applying the survey instrument to participants. The survey and study design were approved by the Institutional Review Panel of Princeton University, New Jersey.

2.2. Survey instrument The NICU directors affirmed that their answers would likely be an accurate representation of resuscitation practices conducted by neonatologists in their group. The survey was devised for this study and consisted of two parts. In the first section, respondents were sequentially presented with a matrix of six scenarios with varied gestational age and parental demands in the form of a clinical vignette, and asked to respond with their course of action. Respondents were posed with the situation that a premature infant had been delivered (at 22, 23, or 24 weeks as determined by early ultrasound), and that either the parents wanted “everything possible” be provided for the baby or that “nothing be done” for the baby. Responses were partially-close ended, and respondents were asked whether they generally would: a) not attend the delivery, because of futility; (b) attend the delivery, evaluate the baby, and not resuscitate; (c) attend the delivery, evaluate the baby, and likely resuscitate; or (d) take an alternate course of action (if described). If the respondent answered with choice (a), he or she was asked the follow-up question of whether legally mandated attendance would change this course of action.

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In the second section of the survey, respondents were asked whether they were aware of BAIPA. If the response was affirmative, the respondents were asked whether this law had changed decision-making process or practice in any way. Finally, respondents were asked whether they viewed the idea of federal legislation mandating physician practice as ethical or unethical. 2.3. Data analysis Fisher exact test for small sample size was used to calculate two-tailed probability values (p < 0.05 was considered statistically significant), and findings were confirmed by chi square. All analyses were completed using Statistica 5.5 (StatSoft, Inc., Tulsa, OK, 2000).

3. Results 3.1. Responses to resuscitation scenarios All contacted physicians agreed to participate (n = 20). At 22 weeks gestational age, 70% (14/20) of physicians would not resuscitate even if parents requested full treatment, though 93% of those (13/14) would attend and assess first (Fig. 1). None would resuscitate at 22 weeks against parental requests to withhold care, with 30% (6/20) not attending the delivery (Fig. 2). At 23 weeks, 75% of physicians (15/20) would attend and resuscitate if parents requested care, in contrast to 15% (3/20) who would attend and resuscitate against parental wishes. 5% (1/20) would not

Fig. 2. Resuscitation practices when parents request that treatment be withheld. Not Attending; Attending, Not Resuscitating; Attending and Resuscitating.

attend the delivery even if parents requested care at 23 weeks, and 25% (4/20) would not attend if the parents requested to withhold care. 20% (4/20) would attend deliveries at 23 weeks to evaluate but not resuscitate if the parents requested care, in contrast to 60% (12/20) if the parents requested to withhold care. In scenarios for births at both 22 and 23 weeks, parental wishes had a significant effect on neonatologists’ decision to resuscitate (p = 0.02 and p = 0.0003, respectively). All neonatologists would provide care for infants born at 24 weeks gestational age when parents requested treatment, and 80% would resuscitate even against parental wishes. Only 20% (4/20) would assess and withhold treatment or not attend the delivery at all in response to parental wishes. There was no significant parental influence on the decision of neonatologists whether to resuscitate infants born at 24 weeks gestational age (p = 0.11). Regardless of the scenario, respondents who stated they would not attend deliveries at the various gestational ages all replied they would not be more likely to resuscitate the infant if mandated by federal legislation to attend the delivery and make an assessment. 3.2. Assessment of legal knowledge and ethical qualification

Fig. 1. Resuscitation practices when parents request that all treatment be provided for the infant. Not Attending; Attending, Not Resuscitating; Attending and Resuscitating.

A total of 75% (15/20) of the surveyed neonatologists were aware of BAIPA and understood its implications. However, none stated that it had led directly to alterations in clinical practice, or that s/he would change his practice in response to similar federal regulations. Consistent with this, 75% (15/20) felt that such legislation dictating physician practice in this area was “unethical”.

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4. Discussion The diversity of practice for births in the 22–24 week gestation period demonstrates the uncertainty over the role of parents in decision-making. While a large majority of surveyed neonatologists (80%) would resuscitate neonates at 24 weeks gestation against parents’ wishes, they placed great weight on parental authority at 22–23 weeks gestation. At 23 weeks, only 15% would resuscitate against parental wishes, and none would resuscitate at 22 weeks when the parents request to withhold. Of note, 25% of surveyed neonatologists also indicated that they would attempt resuscitation on infants at 22 weeks gestation at the parents’ request, despite the near certainty of medical futility. It is possible that this willingness to provide a trial of therapy is based on the fact that, despite advances in technology, there is still significant error in prenatal estimates of gestational age [7, 26–28]. Alternatively, compliance with parental wishes is a default response when there is no effective medical treatment available. Thus, at 22 and 23 weeks, but not 24 weeks, parents played a significant role in decision-making. Consistent with these findings, Ballard et al. reported a significant impact of parental wishes at 22–23 weeks gestation [29]. However, others have reported markedly different approaches at these gestational ages, frequently withholding care despite parental requests to resuscitate [9, 10, 25, 30]. Significant variation in approach at 24 weeks has also been reported. While some previous studies are consistent with our finding that 80% would resuscitate against parental wishes [10, 25, 29, 31], others show a substantial proportion of neonatologists willing to withhold care at the parents’ request [9, 32, 33]. In all studies, it is evident that estimates of gestational age per se play a major role in physician decision-making, presumably because they can be quantified before delivery and are roughly associated with outcome. The question of whether parents or doctors drive treatment decisions is important because it is not possible to neatly define an infant’s “best interest”, and physicians’ judgment can conflict with parents’. The underlying basis for such decisions by both physicians and parents is presumably the likelihood of “meaningful” survival of the child, without major long-term morbidity. However, defining this can be subjective because newborn’s interests exist in a social context that may be determined in part by the interests of the family as a whole [34]. Families may differ

in their capacity to share the burden of suffering for compromised infants. Moreover, both parents and physicians can be strongly influenced by subjective components such as religious beliefs. Court judgments have affirmed that parents are generally the appropriate decision-makers for infants, but have also supported the state’s role as parens patriae, allowing it to intercede if parents are thought to be acting against their child’s best interest. The response to BAIPA by the medical community has evolved. Initially, the American Academy of Pediatrics (AAP) Neonatal Resuscitation Program (NRP) Steering Committee stated that “at the time of delivery, and regardless of the circumstances of the delivery, the medical condition and prognosis of the newly born infant should be assessed” [35]. This approach reinforced the necessity for physicians to evaluate all newborns at birth, regardless of gestational age. However, the statute did not provide guidance for the criteria or degree of certainty required to make decisions on whether to resuscitate. Since there is no clinical test or objective indicator that can accurately predict outcome in infants of borderline viability, divergent resuscitation practices developed across centers. Also, the role of parental wishes was not clearly articulated. Without consensus on these issues, delivery room management remained subjective. In 2005, the revised NRP (AHA-AAP) protocol altered its approach: “When gestation is associated with almost certain early death and when unacceptably high morbidity is likely among the rare survivors (

Resuscitation at the limit of viability: trapped between a rock and a hard place.

Current professional guidelines, such as the Neonatal Resuscitation Program, specify significant roles for parents in decision-making at periviability...
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