Differing Thresholds for Overriding Parental Refusals of Life-Sustaining Treatment.

When should doctors seek protective custody to override a parent's refusal of potentially lifesaving treatment for their child? The answer to this question seemingly has different answers for different subspecialties of pediatrics. This paper specifically looks at different thresholds for physicians overriding parental refusals of life-sustaining treatment between neonatology, cardiology, and oncology. The threshold for mandating treatment of premature babies seems to be a survival rate of 25-50%. This is not the case when the treatment in question is open heart surgery for a child with congenital heart disease. Most cardiologists would not pursue legal action when parents refuse treatment, unless the anticipated survival rate after surgery is above 90%. In pediatric oncology, there are case reports of physicians requesting and obtaining protective custody for cancer treatment when the reported mortality rates are 40-50%. Such differences might be attributed to differences in care, a reasonable prioritization of quality of life over survival, or the role uncertainty plays on prognoses, especially for the extremely young. Nonetheless, other, non-medical factors may have a significant effect on inconsistencies in care across these pediatric subspecialties and require further examinations.

Outcomes in Continuing Pregnancies Diagnosed with a Severe Fetal Abnormality and Implication of Antenatal Neonatology Consultation: A 10-Year Retrospective Study.

PURPOSE: To describe a population choosing to continue their pregnancy despite a severe fetal abnormality and to evaluate the role of antenatal neonatology consultation in perinatal decision-making. METHODS: A 10-year (2005-2015) retrospective descriptive study in a single Multidisciplinary Prenatal Diagnosis Center in South France. A series of pregnancies with severe fetal abnormalities were collected by a person outside the decision making process and/or the child's care. RESULTS: Thirty-nine pregnancies were included, among which 12 couples chose the perinatal palliative care. In total, there were 25 live births (10 later died, with median of survival of 52.5 h [16-943.5]); only five infants received a palliative care plan at birth. CONCLUSION: The choice to continue a pregnancy diagnosed with severe fetal pathology is on the rise in France. Treatment options point to standardize perinatal palliative care provided by trained perinatal professionals using standardized practices.

[Parental Information and Consent in Neonatology]. / Aufklärung in der Neonatologie.

Careful analysis of current adjudication reveals increasing demand of adequate record-keeping as well as meticulously documented informed consent forms regarding all aspects of medicine. Although standardized informed consent forms or explicit guidelines for obtaining procedural consent already exist in surgical disciplines there is strong evidence that, however, in neonatology (and paediatric intensive care) these processes are still incomplete and qualitatively insufficiently implemented. Therefore the author discussed all existing information prescriptions with the legal department and quality management of a large German clinic group especially in terms of relevant legislation, recent case law and specialist literature in order to obtain potential for improvement. Based on the results of this audit of expert opinions improved recommendations could be implemented in the daily practise of a department of neonatology and paediatric intensive care on a tertiary level.

Medical practice and legal background of decisions for severely ill newborn infants: viewpoints from seven European countries.

AIM: To comparing attitudes towards end-of-life (EOL) decisions in newborn infants between seven European countries. METHODS: One paediatrician and one lawyer from seven European countries were invited to attend a conference to discuss the practice of EOL decisions in newborn infants and the legal aspects involved. RESULTS: All paediatricians/neonatologists indicated that the best interest of the child should be the leading principle in all decisions. However, especially when discussing cases, important differences in attitude became apparent, although there are no significant differences between the involved countries with regard to national legal frameworks. CONCLUSION: Important differences in attitude towards neonatal EOL decisions between European countries exist, but they cannot be explained solely by medical or legal reasons.

Patient safety in the context of neonatal intensive care: research and educational opportunities.

Case reports and observational studies continue to report adverse events from medical errors. However, despite considerable attention to patient safety in the popular media, this topic is not a regular component of medical education, and much research needs to be carried out to understand the causes, consequences, and prevention of healthcare-related adverse events during neonatal intensive care. To address the knowledge gaps and to formulate a research and educational agenda in neonatology, the Eunice Kennedy Shriver National Institute of Child Health and Human Development invited a panel of experts to a workshop in August 2010. Patient safety issues discussed were the reasons for errors, including systems design, working conditions, and worker fatigue; a need to develop a "culture" of patient safety; the role of electronic medical records, information technology, and simulators in reducing errors; error disclosure practices; medicolegal concerns; and educational needs. Specific neonatology-related topics discussed were errors during resuscitation, mechanical ventilation, and performance of invasive procedures; medication errors including those associated with milk feedings; diagnostic errors; and misidentification of patients. This article provides an executive summary of the workshop.

[The propriety of establishing the fact of neonatality based on the examination of the child's corpse].

It is shown based on the historical and legal analysis that the designation of the child's status as a newborn infant throughout the period of its neonatal life till violent death "at or immediately after births" is the exclusive prerogative of the law-enforcement authorities. An original approach has been developed and recommended for the introduction into the expert practice. According to this proposal facts and arguments in the "Expert conclusions" should be formulated so as to avoid mentioning the child as newborn and to indicate only the duration of its extrauterine life. Such an approach leaves it to the law-enforcement authorities to decide in each concrete case whether the child should be designated as a newborn infant or not.

End-of-life decisions in dutch neonatology.

This contribution describes the regulation of end-of-life decisions in neonatology in the Netherlands. An account is given of the process of formulating rules, which includes a report by the Dutch Association for Paediatrics, two Court rulings, a report by a Consultation Group appointed by the Ministry of Health and a professional Protocol regulating deliberate ending of life in neonatology that was subsequently adopted as the regulation of this type of decision-making at the national level. The paper presents Dutch and comparative data on the attitude of the medical profession towards end-of-life decisions in neonatology and the frequency of such decisions in medical practice.

Designation of neonatal levels of care: a review of state regulatory and monitoring policies.

OBJECTIVE: Summarize policies on levels of neonatal care designation among 50 states and District of Columbia (DC). STUDY DESIGN: Systematic review of publicly available, web-based information on levels of neonatal care designation policies for each state/DC. Information on designating authorities, designation oversight, licensure requirement, and ongoing monitoring for designated levels of care abstracted from 2019 published rules, statutes, and regulations. RESULT: Thirty-one (61%) of 50 states/DC had designated authority policies for neonatal levels of care. Fourteen (27%) incorporated oversight of neonatal levels of care into the licensure process. Among jurisdictions with designated authority, 25 (81%) used a state agency and 15 (48%) had direct oversight. Twenty-two (71%) of 31 states with a designating authority required ongoing monitoring, 14 (64%) used both hospital reporting and site visits for monitoring with only ten requiring site visits. CONCLUSIONS: Limited direct oversight influences regulation of regionalized systems, potentially impacting facility service monitoring and consequent management of vulnerable infants.

Variation in States' Implementation of CAPTA's Substance-Exposed Infants Mandates: A Policy Diffusion Analysis.

In 2016, federal law changed state child welfare mandates related to prenatally substance-exposed infants. Little is known regarding the status or implications of policy implementation. The current study examined thematic clusters among states' policies responsive to this 2016 mandate. Cluster analysis identified four distinct categories of states' implementation: (1) "innovators/early adopters," (2) "early majority," (3) "late majority," and (4) "laggards." Innovator/early adopter states (n = 14) were most likely to have implemented plan of safe care policies consistent with Child Abuse Prevention and Treatment Act (CAPTA). Early majority states (n = 15) have started developing some aspects of CAPTA 2016 but have some aspects that are still in development. Late majority states (n = 17) have adopted few aspects of CAPTA 2016 but had implemented more CAPTA 2003 and 2010 aspects than states in the laggard cluster. Laggard states (n = 6) have implemented the fewest CAPTA prenatal substance exposure domains. In bivariate analyses, the only variable associated with clusters was Census region (e.g., New England), suggesting that states' implementation decisions may be influenced by their regional neighbors.

Limit of viability in Japan: ethical consideration.

Viability means "the quality or state of being able to live, grow and develop." Limit of viability has been changed along with the advancement of perinatal and neonatal medicine. The viability limit defined in the Japanese Motherhood Protection Act was amended from 24 to 22 completed weeks of gestation in 1991 based on the survival rate of extremely preterm infants. Survival rates of infants at 22 and 23 weeks' gestation born between 2002 and 2004 in Japan were 31% and 56%, respectively. Though medical data are the most important means to define viability, socio-economical and ethical factors should be also considered, especially when we discuss the group of marginally viable infants. We think there are two different categories of viability limits, one from biological survival limit and another from social agreement of providing active medical intervention. Currently in Japan, the former viability definition based on purely medical data is 22 completed weeks and the latter definition is the social consensus of about 24-28 weeks' gestation.

Clinical, ethical and legal considerations in the treatment of newborns with non-ketotic hyperglycinaemia.

Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy. The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient. The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.

Dignified death for severely impaired infants: beyond the best-interest standard.

The Baby Doe rules, a set of federal regulations on the treatment of extremely ill infants, went into effect in 1985. Some scholars have argued that these rules are inappropriate given that they fail to pay attention to the patient's suffering. Instead, researchers suggest that, when dealing with a severely impaired infant, the best-interest standard be used. Other ethicists have found the best-interest standard also insufficient, deeming it to be supported by weak arguments rooted on the beholder's beliefs. In this article, alternative viewpoints that might be used to complement the best-interest standard and help support the rights of severely impaired infants to a natural and dignified death are reviewed. The use of palliative instead of intensive care for severely impaired newborns is also considered.

'Do not resuscitate order' in neonatology: authority rules.

Ethical dilemmas in medicine should be resolved in light of four essential principles. To specify and guide concrete actions, it is necessary to 'supplement' these principles by certain other (substantive, authority and procedural) rules. The purpose of this paper is to establish and justify the authority rules regarding the order not to resuscitate newborns. The authority rules are intended to indicate who should decide, but they do not determine what should be chosen. Decision regarding newborn's treatment/letting die depends on medical and quality-of-life judgments. Parents, doctors, and society are considered to possess decisional authority in the matter. However, who in a given case should decide ought to be inferred from the reasoning which assumes, as its premises, the medical and quality-of-life judgments. The 'logical' syntax of this reasoning is presented in this paper.

[The Italian law on termination of pregnancy (194/1978). Should it be revised? The palliative care option]. / Terapia palliativa del feto/neonato con malformazioni incompatibili con la vita: una opzione alternativa alla interruzione di gravidanza.

The section of the Italian law on the termination of pregnancy (no. 194/1978) regarding late termination is revised and discussed in the light of the various options that could be offered to parents. Besides recent suggestions to apply time limits, the author reviews an alternative therapeutic option, considered the only feasible revision of the law which calls for strong involvement by the neonatologist and close collaboration with the obstetrician: the offer of palliative care for foetus/neonate and parents.

Communication-related allegations against physicians caring for premature infants.

OBJECTIVE: Maternal-fetal medicine physicians (MFMp) and neonatal-perinatal medicine physicians (NPMp) caring for premature infants and their families are exposed to significant risk for malpractice actions. Effective communication practices have been implicated to decrease litigious intentions but the extent of miscommunication as a cause of legal action is essentially unknown in this population. Analysis of communication-related allegations (CRAs) may help toward improving patient care and physician-patient relationships as well as decrease litigation risks. STUDY DESIGN: We retrospectively reviewed the Westlaw database, a primary online legal research resource used by United States lawyers and legal professionals, for malpractice cases against physicians involving premature infants. Inclusion criteria were: 22 to 36 weeks gestational age, cases related to peripartum events through infant discharge and follow-up, and legal records with detailed factual narratives. RESULTS: The search yielded 736 legal records, of which 167 met full inclusion criteria. A CRA was identified in 29% (49/167) of included cases. MFMp and/or NPMp were named in 104 and 54 cases, respectively. CRAs were identified in 26% (27/104) and 35% (19/54) of MFMp- and NPMp-named cases, respectively, with a majority involving physician-family for both specialties (81% and 74%, respectively). Physician-family CRAs for MFMp and NPMp most often regarded lack of informed consent (50% and 57%, respectively), lack of full disclosure (41% and 29%, respectively) and lack of anticipatory guidance (36% and 21%, respectively). CONCLUSIONS: This study of a major legal database identifies CRAs as significant causes of legal action against MFMp and NPMp involved in the care of high-risk women and infants delivered preterm. Physicians should be especially vigilant with obtaining genuine informed consent and maintaining open communication with families.

Consent for neonatal research.

Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process.

The future of neonatal therapeutic trials.

Neonatology has undoubtedly benefited from clinical trials. Nevertheless, more treatments based on inadequate experimental evidence are given than those that are supported by a validated evidence base. Clinicians seeking the basis for their current and future clinical practice are faced with challenges in the shadow of recent UK legislation and government recommendations. All patients must be protected from inappropriate research, but the benefits of regulations must be appropriately balanced with those of properly conducted clinical trials. It is ethically difficult both to persist with treatments of unproven benefit and unknown harm and to deny infants potentially valuable therapies. It is important that trials are conducted within the new legislative framework, but their future may rest with innovative solutions and the determination of all involved in the process.