The impact of neonatal unit policies on breast milk feeding at discharge of moderate preterm infants: The EPIPAGE-2 cohort study.

Facilitating factors and barriers to breast milk feeding (BMF) for preterm infants have been mainly studied in very preterm populations, but little is known about moderate preterm infants. We aimed to analyze hospital unit characteristics and BMF policies associated with BMF at discharge for infants born at 32 to 34 weeks' gestation. EPIPAGE-2, a French national cohort of preterm births, included 883 infants born at 32 to 34 weeks' gestation. We investigated kangaroo care in the first 24 hr, early involvement of parents in feeding support, volume of the unit, BMF information given to mothers hospitalized for threatened preterm delivery, protocols for BMF, presence of a professional trained in human lactation, unit training in neurodevelopmental care, and regional BMF initiation rates in the general population. Multilevel logistic regression analysis was used to investigate associations between unit policies and BMF at discharge, adjusted for individual characteristics and estimating odds ratios (ORs) and 95% confidence intervals (CIs). Overall, 59% (490/828) of infants received BMF at discharge (27% to 87% between units). Rates of BMF at discharge were higher with kangaroo care (adjusted OR 2.03 [95% CI 1.01, 4.10]), early involvement of parents in feeding support (1.94 [1.23, 3.04]), unit training in a neurodevelopmental care programme (2.57 [1.18, 5.60]), and in regions with a high level of BMF initiation in the general population (1.85 [1.05, 3.28]). Creating synergies by interventions at the unit and population level may reduce the variability in BMF rates at discharge for moderate preterm infants.

Medico-legal implications of hypothermic neuroprotection in the newborn.

Hypoxic-ischemic encephalopathy (HIE) continues to be a significant source of long term neurological sequelae in infants born at or near term. In the past decade, selective head or whole body cooling has shown promising benefit in ameliorating some of the brain injury from intrapartum asphyxial insults and has become standard care in most developed countries. A decision to offer neuroprotective hypothermia (NPH) may engender subsequent litigation because it presupposes an acute intrapartum injury. Conversely, failing to offer cooling may be interpreted as a violation in the standard of care. In this paper, we review the clinical aspects of NPH and the medico-legal scenarios often seen after acute birth injury.

[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.

Beyond Bioethics: A Child Rights-Based Approach to Complex Medical Decision-Making.

This analysis adopts a child rights approach-based on the principles, standards, and norms of child rights and the U.N. Convention on the Rights of the Child (CRC)-to explore how decisions could be made with regard to treatment of a severely impaired infant (Baby G). While a child rights approach does not provide neat answers to ethically complex issues, it does provide a framework for decision-making in which the infant is viewed as an independent rights-holder. The state has obligations to develop the capacity of those who make decisions for infants in such situations to meet their obligations to respect, protect, and fulfill their rights as delineated in the CRC. Furthermore, a child rights approach requires procedural clarity and transparency in decision-making processes. As all rights in the CRC are interdependent and indivisible, all must be considered in the process of ethical decision-making, and the reasons for decisions must be delineated by reference to how these rights were considered. It is also important that decisions that are made in this context be monitored and reviewed to ensure consistency. A rights-based framework ensures decision-making is child-centered and that there are transparent criteria and legitimate procedures for making decisions regarding the child's most basic human right: the right to life, survival, and development.

Policy change for infants born at the "cusp of viability": a Canadian NICU experience.

Resuscitation and life-support treatments for infants born at the "cusp of viability" continue to be subject to clinical and ethical debate. Reported positive outcomes for these infants led our Neonatal Program to critically review our historic practice of discouraging resuscitation of infants born at <24 weeks' gestational age. This practice change required a multifaceted, collaborative approach including neonatal, perinatal, and obstetric efforts. An exceptional experience was the formation of a dedicated working group that included invaluable input from parents who had lived the NICU experience. The inclusion of family members in the development of clinical policy was a novel experience for NICU staff, which we feel ultimately resulted in a more ethically sound approach to the care of these infants and their families. In this article, we explore our experience of the process of policy change, which although detailed and transparent was also complex and challenging in development and implementation.

The association of state legal mandates for data submission of central line-associated bloodstream infections in neonatal intensive care units with process and outcome measures.

OBJECTIVE: To determine the association between state legal mandates for data submission of central line-associated bloodstream infections (CLABSIs) in neonatal intensive care units (NICUs) with process and outcome measures. DESIGN: Cross-sectional study. PARTICIPANTS: National sample of level II/III and III NICUs participating in National Healthcare Safety Network (NHSN) surveillance. METHODS: State mandates for data submission of CLABSIs in NICUs in place by 2011 were compiled and verified with state healthcare-associated infection coordinators. A web-based survey of infection control departments in October 2011 assessed CLABSI prevention practices, ie, compliance with checklist/bundle components (process measures) in ICUs including NICUs. Corresponding 2011 NHSN NICU CLABSI rates (outcome measures) were used to calculate standardized infection ratios (SIRs). Association between mandates and process and outcome measures was assessed by multivariable logistic regression. RESULTS: Among 190 study NICUs, 107 (56.3%) were located in states with mandates, with mandates in place >3 years in 52 (49%). More NICUs in states with mandates reported ≥95% compliance to at least 1 CLABSI prevention practice (52.3%-66.4%) than NICUs in states without mandates (28.9%-48.2%). Mandates were predictors of ≥95% compliance with all practices (odds ratio, 2.8; 95% confidence interval, 1.4-6.1). NICUs in states with mandates reported lower mean CLABSI rates in the ≤750-g birth weight group (2.4 vs 5.7 CLABSIs/1,000 central line-days) but not in others. Mandates were not associated with SIR <1. CONCLUSIONS: State mandates for NICU CLABSI data submission were significantly associated with ≥95% compliance with CLABSI prevention practices, which declined with the duration of mandate but not with lower CLABSI rates.

The effectiveness of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations.

PURPOSE: To determine the effectiveness of a series of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations. METHODS: We retrospectively reviewed the records of consecutive neonatal intensive care unit patients before and after the implementation of policy changes. Policy changes included parent education forms, streamlined scheduling, and creation of a log for all patients seen. The primary outcome measure was attendance rates for the first outpatient appointment after discharge. The Fisher exact test was used to compare rates between the two groups. RESULTS: Before the policy was implemented, 22 of 52 (42%) neonates and their caregivers attended their first outpatient ROP screening examination on the recommended date. This rate improved significantly after policy implementation, when 46 of 57 (81%) neonates and their caregivers were seen on the recommended date (P < 0.01). The number of patients who ultimately met the criteria for conclusion of acute retinal screening examinations also significantly improved, from 47 of 52 (90%) of neonates in the pre-implementation group to 57 of 57 (100%) in the post-implementation group (P = 0.02). CONCLUSIONS: The attendance rates for initial outpatient ROP examinations and the number of patients who ultimately met criteria for conclusion of acute retinal screening examinations significantly improved after the implementation of new policies.

Tweets, friends, and links: the use of social media by NICU health care providers.

Most of us are connected in some way to contacts through social media. Not only is it a great way to keep in touch and up-to-date but can also be a way to communicate with parents or guardians of patients in the NICU. However, along with the benefits comes the potential for abuse and or the unintentional disclosure of patient information.

Resuscitation of likely nonviable infants: a cost-utility analysis after the Born-Alive Infant Protection Act.

OBJECTIVE: The purpose of this study was to compare the effects of universal vs selective resuscitation on maternal utilities, perinatal costs, and outcomes of preterm delivery and termination of pregnancy at 20-23 weeks 6 days' gestation. STUDY DESIGN: We used studies on medical practices, prematurity outcomes, costs, and maternal utilities to construct decision-analytic models for a cohort of annual US deliveries after preterm delivery or induced termination. Outcome measures were (1) the numbers of infants who survived intact or with mild, moderate, or severe sequelae; (2) maternal quality-adjusted life years (QALYs); and (3) incremental cost-effectiveness ratios. RESULTS: Universal resuscitation of spontaneously delivered infants between 20-23 weeks 6 days' gestation increases costs by $313.1 million and decreases QALYs by 329.3 QALYs; after a termination, universal resuscitation increases costs by $15.6 million and decreases QALYs by 19.2 QALYs. With universal resuscitation, 153 more infants survive: 44 infants are intact or mildly affected; 36 infants are moderately impaired, and 73 infants are severely disabled. CONCLUSION: Selective intervention constitutes the highest utility and least costly treatment for infants at the margin of viability.

Red blood cell transfusion in preterm infants: restrictive versus liberal policy.

Preterm neonates represent a category of patients with high transfusion needs. Ideally, red blood cells (RBC) transfusion should be tailored to the individual requirements of the single infant. However, despite the progress in neonatal transfusion medicine, many controversies still remain, and the decision on whether to transfuse or not is often made on empirical basis, with large variation in transfusion practices among neonatologists. Recently, a few clinical trials have been performed with the aim to compare the risk/benefit ratio of restrictive versus liberal transfusion criteria. Most of the studies failed to demonstrate significant differences in short-term outcomes, suggesting that the restrictive criteria may reduce the need for transfusion and the related side effects. Neurodevelopmental long-term outcome seemed more favorable in the liberal group at a first evaluation, especially for boys, and significantly better in the restrictive group at a later clinical investigation. Magnetic resonance imaging scans, performed at an average age of 12 years, showed that intracranial volume was substantially smaller in the liberal group compared with controls. When sex effects were evaluated, the girls in the liberal group had the most significant abnormalities. In conclusion, when preventive measures, as favoring cord clamping delay or cord milking, ensuring optimal nutrition, and minimizing phlebotomy losses, fail to avoid the need for transfusion, it is preferable to adopt restrictive criteria.

Off-label drugs prescription in neonatology: a physician's duty or a medical hazardous attitude?

The off-label and unlicensed use of drugs in neonatology is a widespread reality in all the NICUs. Several explanations may be given to justify the extension of this phenomenon and, among them, the lack of ad hoc clinical trials in neonatal subpopulation and the freedom to cure worldwide recognized to relatives and physicians. It is well known that adverse effects are more frequent, more serious and more underreported when medicines are used unauthorized or off-label, being physicians in theory responsible for the newborn physical damage. To avoid this responsibility, we believe that a shared legal framework may be helpful where the informative process on risks/benefits ratio for the newborn has a pivotal role. The National and International Scientific Societies should promote a common guidelines also for the informations on drug effects to be supplied to relatives. But at the same time EMA has to implement its strong policy towards the mandatory request on trials, for every new drug, on specific neonatal and pediatric subpopulations.

Evidence-based platelet transfusion recommendations in neonates.

Even though for certain varieties of neonatal thrombocytopenia, intravenous immunoglobulin or corticosteroids are recommended as treatments, platelet transfusions represent the only specific therapy currently available for most thrombocytopenic neonates in NICUs. The majority of these NICU platelet transfusions, up to 98% in some recent reports, are given to prevent, rather than to treat, bleeding. The trigger limit of platelet count to prophylactically treat non-bleeding patients is generally arbitrary. A complete definition, of the benefits and the risks of prophylactic platelet transfusions in thrombocytopenic neonates is necessary. In fact, there is great variability worldwide in neonatal platelet transfusion practice, due to the lack of concrete evidence to guide transfusion decisions. Evidence-based guidelines do not exist to decide when platelet transfusion should be given. The practice of neonatal platelet transfusions is based almost entirely on expert opinion and reasoning. Consequently, these practices, not supported by definitive data, vary widely. To increase benefits and safety, new widespread changes in platelet transfusion guidelines are necessary. New transfusion paradigms should not be based on reasoning alone, but on important experimental validation. The neonatologists would better accept them and more closely adhere to.

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.

Failure to rescue in neonatal care.

Failure to rescue (FTR) has been described as the end result of a series of events relating to the environment of care and nursing quality. Only recently has FTR as a process measure been applied to perinatal care settings. Nurses' continuous presence at the bedside puts them in a privileged position to recognize signs of clinical deterioration and to take action. Many factors contribute to nurses' ability to save lives when infants develop complications. Although such factors are often system-related, nurses may be held responsible if they do not act according to an acceptable standard of care. In the neonatal intensive care unit, FTR has not been applied or adopted as a measure of nursing quality. This article describes how FTR is relevant in the neonatal intensive care unit and outlines nursing and system actions that can be taken to rescue some of the hospital's most vulnerable patients.

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.

Ethically complex decisions in the neonatal intensive care unit: impact of the new French legislation on attitudes and practices of physicians and nurses.

OBJECTIVES: A statute enacted in 2005 modified the legislative framework of the rights of terminally ill persons in France. Ten years after the EURONIC study, which described the self-reported practices of neonatal caregivers towards ethical decision-making, a new study was conducted to assess the impact of the new law in neonatal intensive care units (NICU) and compare the results reported by EURONIC with current practices. SETTING AND DESIGN: The study was carried out in the same two NICU as in the EURONIC qualitative study. A third centre was added to increase the sample size. From February to October 2007, 19 physicians and 17 nurses participated in semistructured interviews very similar to those for EURONIC. Content analysis identified the recurring themes emerging from the interviews. RESULTS: Compared with the EURONIC results, the caregivers reported that they pay greater attention to the views of parents and provided respectful support to the neonates when life-sustaining treatment is withdrawn. Active termination of life has become exceptional. The possibility of withdrawal of treatment, the administration of sedatives to control pain even at the risk of hastening death, the emphasis on sparing parents the burden of decision, and the relative ignorance of the law were very similar to the EURONIC findings. CONCLUSION: Both the medical and the legal regulation of practices has allowed more dialogue with the parents and more humane care for dying newborns. A new European study is necessary to investigate the possible changes in practices and attitudes also in other countries.