Neonatal end-of-life decision-making almost 20 years after the EURONIC study: A French survey.

Nearly 20 years ago the EURONIC study reported that French neonatologists sometimes deemed it legitimate to terminate the lives of newborn infants when the prognosis appeared extremely poor. Parents were not always informed of these decisions. Major change has occurred since then and is described herein. MATERIAL AND METHODS: A survey was conducted in the Île-de-France region, from 1 January to 31 January 2016. Professionals from 15 neonatal intensive care units (NICUs) were invited to complete a questionnaire. RESULTS: A total of 702 questionnaires were collected and 670 responses were analyzed. Knowledge of the law differed according to professional status, with 71% of MDs (medical staff, MS), compared with 28% of nonmedical staff (NMS) declaring that they had good knowledge of the law. Most MDs and NMS believed that withholding or withdrawing life-sustaining treatments (WWLST) could be decided and implemented after a delay. Half of them thought that WWLST would always result in death. Although required by law, a consulting MD attended the collegial meeting required before deciding on WWLST in only half of the cases. Parents were almost always informed of the decision thereafter by the physician in charge of their infant. The most frequent disagreement with parents was observed when WWLST was the option selected. In this case, most professionals suggested postponing WWLST, continuing intensive care and dialogue with parents, aiming at a final shared decision. Major differences were observed between NICUs with regard to the withdrawal of artificial nutrition and hydration. Finally, 14% of MDs declared that infant active terminations of life still occurred in their NICU. Major differences concern WWLST and active termination of life, whose meaning has been partly modified since 2001. CONCLUSION: Several major changes were observed in this survey: (1) treatment withdrawal decisions are made today in agreement with the law; (2) parents' information and involvement in the decision process have profoundly changed; (3) active termination of life (euthanasia) very rarely occurs; only at the end of a process in accordance with ethical principles and within the law is this decision made.

[Palliative care after neonatal intensive care: Contributions of Leonetti Law and remaining challenges]. / Soins palliatifs au décours d'une réanimation néonatale : apports de la loi Léonetti et défis persistants.

The 2005 enactment of the "Patients' rights and end-of-life care" act, known as the Leonetti law, has been accompanied by practical changes in the processes of withdrawal and withholding of active life-sustaining treatments. This law has also promoted the implementation of palliative care in perinatal medicine to avoid unreasonable therapeutic interventions and to preserve the dying patient's quality of life and human dignity. Recently, a new law has been voted by the French National Assembly and new reflections on the ethical aspects of the end of life in neonatal medicine should resume again within the French Society of Neonatology in the working group on ethical issues in neonatology. This is why it appears important to discuss the perceived benefits and the persistent difficulties related to the implementation of the Leonetti law in neonatology. Collegiality in the decision-making processes as well as withdrawal and withholding of life-sustaining treatments that were already present in the practices of many centers has been stipulated within a legal framework and promoted in clinical practice. It has brought serenity within perinatal nursing and medical teams. It has helped them face the always-difficult end-of-life situations with parents and deal with decision-making processes in an intense emotional climate. However, new questions inherent to the law have appeared. The most important ones concern the withholding of artificial nutrition and hydration, the time pressure in the management of the decision-making process, and the management of the duration of palliative care. Challenges remain in addressing various persistent ethical dilemmas such as the possible survival of newborns with significant brain lesions detected after the period of life-sustaining treatments that have allowed their survival. The new law carried by Mr. Clayes and Mr. Léonetti should provide answers to some of these ethical issues, but it would probably not solve all of them.

US and territory telemedicine policies: identifying gaps in perinatal care.

BACKGROUND: Perinatal regionalization is a system of maternal and neonatal risk-appropriate health care delivery in which resources are ideally allocated for mothers and newborns during pregnancy, labor and delivery, and postpartum, in order to deliver appropriate care. Typically, perinatal risk-appropriate care is provided in-person, but with the advancement of technologies, the opportunity to provide care remotely has emerged. Telemedicine provides distance-based care to patients by consultation, diagnosis, and treatment in rural or remote US jurisdictions (states and territories). OBJECTIVE: We sought to summarize the telemedicine policies of states and territories and assess if maternal and neonatal risk-appropriate care is specified. STUDY DESIGN: We conducted a 2014 systematic World Wide Web-based review of publicly available rules, statutes, regulations, laws, planning documents, and program descriptions among US jurisdictions (N = 59) on telemedicine care. Policies including language on the topics of consultation, diagnosis, or treatment, and those specific to maternal and neonatal risk-appropriate care were categorized for analysis. RESULTS: Overall, 36 jurisdictions (32 states; 3 territories; and District of Columbia) (61%) had telemedicine policies with language referencing consultation, diagnosis, or treatment; 29 (49%) referenced consultation, 30 (51%) referenced diagnosis, and 35 (59%) referenced treatment. In all, 26 jurisdictions (22 states; 3 territories; and District of Columbia) (44%), referenced all topics. Only 3 jurisdictions (3 states; 0 territories) (5%), had policy language specifically addressing perinatal care. CONCLUSION: The majority of states have published telemedicine policies, but few specify policy language for perinatal risk-appropriate care. By ensuring that language specific to the perinatal population is included in telemedicine policies, access to maternal and neonatal care can be increased in rural, remote, and resource-challenged jurisdictions.

Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants.

OBJECTIVE: The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. DESIGN/PARTICIPANTS/SETTING: PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. RESULTS: While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care. CONCLUSIONS: SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these differences, are essential elements of adequate informed consent.

[Analysis of the Debate on Neonatal Euthanasia Using Present Bioethical Literature]. / Análisis del Debate Sobre la Eutanasia Neonatal a Través de la Literatura Actual.

Nowadays, most of the deaths in neonatal ages take place in neonatal intensive care units and a significative number of these are involved in decisions of withholding or withdrawing medical care. The growing complexity of the health care in neonatal settings entails that end-of-life decision-making occurs more frequently. Personal views and attitudes on the best care of the severely ill newborns can be different, since to define objectively the ″best interests″ for the infant is not easy at all. The question of how to best care for such infants is ongoing, and there remain deep divisions within the field. The aim of this issue is to review the different criteria used in the western world, Europe, especially in the Netherlands, and the EEUU and the current debate on neonatal euthanasia. Poor vital prognosis, current and future quality of life and, after the Groningen protocol, unbearable suffering are the criteria commonly used in neonatal end-of-life decisions, including euthanasia. It is necessary to distinguish the decisions, in which euthanasia is chosen, of which they are an appropriate limit of therapeutic effort.

[The Best Interest of the Child in Neonatology: Is It Best for the Child?]. / El Mejor Interés del Niño en Neonatología: ¿Es lo Mejor para el Niño?

Since its inceptions, the standard of best interest of the child was linked to decisions about suspend life-sustaining treatments in neonatal units and evaluation of treatments applied to children in terms of their quality of life. This origin has conditioned the interpretation of the standard from two extremes: a vitalistic one, and a non vitalistic interpretation that triumphed in Western bioethics and has led to the consecration of the standard of best interest of the child in the Convention on the Rights of the Child of United Nations. A detailed analysis reveals a simplistic, utilitarian and proportionalist standard, which change the basis of parenthood. We therefore believe that the standard of the best interest of the child is not the best for the child in neonatal intensive care units and especially not in the process of withhold or withdrawal life-sustaining treatments.

Borderline viability: controversies in caring for the extremely premature infant.

Controversy surrounding the decision to resuscitate at the limits or borderline of viability has been at the center of neonatal ethical debate for decades. This debate has led to numerous reports from individual institutions, councils, and advisory committees that all have remarkable consistency in the development of gestational age-based guidelines. This article reviews legal or regulatory concerns that may contradict ethical discussion and guidelines, discriminatory and scientific basis concerns with consensus guidelines, and personal controversy about how to determine best interest. Guidelines are a reasonable place to start in helping determine parental authority and autonomy. The article also addresses controversies raised in counseling and costs.

[Omission of treatment of severely ill neonates]. / Undladelse af behandling hos svært syge neonatale børn.

For the past two decades it has been common practice in Denmark to withhold or withdraw medical care from neonates born before 28 weeks of gestation if they have poor survival chances or risk of future complications (poor quality of life). This practice is neither supported by the Danish Health Law, a law which furthermore does not include a consideration to quality of life, nor fully recognized as neonatal euthanasia. This is unacceptable as it results in a lack of proper guidelines relating to moral aspects and a failure to understand the full moral impact of neonatal euthanasia.

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.

Palliative care for the newborn in the United Kingdom.

Palliative care for the newborn is a developing area. There are more than 2000 estimated neonatal deaths each year in the UK from causes likely to benefit from palliative care. There is an increasing recognition that while the goals of care may be different for dying newborns, they deserve the same high standard of care as those babies who go on to survive. Recent neonatal palliative care guidance is available from the British Association for Perinatal Medicine (BAPM), the General Medical Council (GMC), and ACT (the U.K. association for children's palliative care). We attempt to answer the question: 'What does the provision of good neonatal palliative care look like?' by examining the factors important in the provision of such care.

Withholding or withdrawal of life sustaining treatment for newborn infants.

In the last two decades the survival of extreme preterm infants and sick newborn infants has improved significantly due to the advances in perinatal medicine. Despite this advance, for some babies, withholding or withdrawal of life sustaining treatment may be the best option in the interest of the baby. An overview of when to consider withholding or withdrawal of life sustaining treatment is described. The decision making process and factors influencing parents decision, how to resolve disagreement, what treatment can be withheld or withdrawn are explained. High quality palliative care must be provided after withholding or withdrawal of life sustaining treatment.

Reconciling ethical and legal aspects in neonatal intensive care.

During the last two decades there has been an enormous development in treatment possibilities for the extremely premature infants and the Neonatologists have to face in their daily practice many decisional problems and ethical, moral and legal dilemmas. These concern decisions to initiate or withhold treatment directly at birth, decision to withdrawn treatment with the possible consequence that the child will die. The debate between "sanctity" and "quality" of life, aggressive treatment in relation to discrimination toward the disabled, the principle of "beneficence" and the question of "proportionality" of treatment, the concept of the newborn's "best interest" are the ethical issues discussed. According to our opinion, ethical questions should not be regulated by law and the legal system should not interfere in the relationship patient - physician. Today more than ever, every neonatologist needs to become familiar with basic ethical concepts and the legal aspects in neonatal intensive care.

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.

Routine Lactobacillus rhamnosus GG administration in VLBW infants: a retrospective, 6-year cohort study.

BACKGROUND: In preterm neonates, use of probiotic mixtures is increasingly popular and is effective in preventing NEC, fungal colonization, and improving feeding tolerance. However, concerns exist about safety and tolerability of long-lasting administration of living microrganisms to not-immunocompetent hosts. We report a 6-year, two-NICUs experience of routinary Lactobacillus rhamnosus GG (LGG) use in VLBW infants. METHODS: Clinical charts review, retrospective study of VLBW infants admitted to two Italian NICUs in the years 2003-2008. Standard protocol of LGG administration consisted of 3 x 109 CFU/day, in single oral dose, since 4th day-of-life, for 4-to-6-week courses. Nutritional policy relied on administration of fresh, expressed mother's milk, supplementation with preterm formula if needed. Data about LGG safety and tolerability, infections, feeding tolerance, microbiological clinical and surveillance cultures were retrieved and analysed. RESULTS: Complete data were obtained for 743 of 811 VLBW infants. Mean birth-weight was 1056 g; mean gestational age 29.5 weeks. A total of 17,108 LGG doses were administered (mean 23.1/infant). No adverse effects or intolerances putatively attributable to LGG occurred. Overall, 5350 clinical and surveillance cultures from 13 different sites/devices were performed (mean: 7.2 cultures from 6.5 different sites/infant). None ever grew LGG, or other Lactobacilli. No clinical sepsis episode was attributable to LGG. Full enteral feeding was achieved at 19.2 mean days-of-life; 73% of infants were exclusively/partially breastfed. Fourteen NEC cases occurred (=1.9%), with 5 (=0.7%) being>2b stage. CONCLUSIONS: Routinary supplementation of probiotic LGG in a large, 6-year VLBW infants Italian cohort proved microbiologically safe and clinically well tolerated.