Predictors of successful treatment of respiratory distress with aerosolized calfactant.

INTRODUCTION: Predictors for successful aerosolized surfactant treatment are not well defined. OBJECTIVE: To identify predictors for successful treatment in the AERO-02 trial and the AERO-03 expanded access program. METHODS: Neonates receiving nasal continuous positive airway pressure (NCPAP) at the time of first aerosolized calfactant administration were included in this analysis. Associations between demographic and clinical predictors to need for intubation were examined using univariate testing and multivariate logistic regression analyses. RESULTS: Three hundred and eighty infants were included in the study. Overall, 24% required rescue by intubation. Multivariate modeling revealed that the predictors of successful treatment were a gestational age ≥31 weeks, a respiratory severity score (RSS) of <1.9, and <2 previous aerosol treatments. CONCLUSION: Gestational age, number of aerosols, and RSS are predictive of successful treatment. These criteria will help select patients most likely to benefit from aerosolized surfactant.

Implementation and Outcomes of a Telehealth Neonatology Program in a Single Healthcare System.

Background: Intermountain Healthcare, an early adopter and champion for newborn video-assisted resuscitation (VAR), identified a reduction in facility-level transfers and an estimated savings of $1. 2 million in potentially avoided transfers in a 2018 study. This study was conducted to increase understanding of VAR at the individual, newborn level. Study Aim: To compare transfers to a newborn intensive care unit (NICU), length of stay (LOS), and days of life on oxygen between newborns managed by neonatal VAR and those receiving standard care (SC). Methods: This retrospective, nonequivalent group study includes infants born in an Intermountain hospital between 2013 and 2017, 34 weeks gestation or greater, and requiring oxygen support in the first 15 minutes of life. Data came from billing and clinical records from Intermountain's enterprise data warehouse and chart reviews. We used logistic regression to estimate neonatal VAR's impact on transfers. Negative binomial regression estimated the impact on LOS and days of life on supplemental oxygen. Results: The VAR intervention was used in 46.2 percent of post-implementation cases and is associated with (1) a 12 percentage points reduction in the transfer rate, p = 0.02, (2) a reduction in spoke hospital (SH) LOS of 8.33 h (p < 0.01) for all transfers; (3) a reduction in SH LOS of 2.21 h (p < 0.01) for newborns transferred within 24 h; (4) a reduction in SH LOS of 17.85 h (p = 0.06) among non-transferred newborns; (5) a reduction in days of life on supplemental oxygen of 1.4 days (p = 0.08) among all transferred newborns, and (6) a reduction in days of life on supplemental oxygen of 0.41 days (p = 0.04) among non-transferred newborns. Conclusion: This study provides evidence that neonatal VAR improves care quality and increases local hospitals' capabilities to keep patients close to home. There is an ongoing demand for support to rural and community hospitals for urgent newborn resuscitations, and complex, mandatory NICU transfers. Efforts may be necessary to encourage neonatal VAR since the intervention was only used in 46.2 percent of this study's potential cases. Additional work is needed to understand the short- and long-term impacts of Neonatal VAR on health outcomes.

A New Hour-Specific Serum Bilirubin Nomogram for Neonates ≥35 Weeks of Gestation.

OBJECTIVE: To develop a statistically rigorous, hour-specific bilirubin nomogram for newborns based on a very large data set; and use it prospectively as a replacement for the 1999 Bhutani nomogram. STUDY DESIGN: This was a retrospective analysis of first total serum bilirubin (TSB) measurements from 15 years of universal bilirubin screening during birth hospitalizations at 20 Intermountain Healthcare hospitals. Hour-specific TSB values were assembled into a nomogram by percentile, and subgroups were compared. RESULTS: The information obtained included robust data in the first 12 hours after birth (which was not included in the 1999 nomogram), general agreement with the 1999 nomogram for values in the first 60 hours, but higher 75th and 95th percentile TSB values thereafter in the new version, no difference in TSB between male and female infants, higher TSB values among earlier gestation neonates (350/7-366/7 weeks vs ≥37 weeks, P < .0001), and lower TSB values in neonates of Black race (P < .0001) and higher values in neonates of Asian race (P < .001). CONCLUSIONS: An updated and more informative Bhutani neonatal bilirubin nomogram, based on 140 times the number of subjects included the 1999 version, is now in place in our health care system.

Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.

Background: Neonatal hypoxia-ischemia encephalopathy (HIE) is the leading cause of neonatal death and poor neurodevelopmental outcomes worldwide. Therapeutic hypothermia (TH), while beneficial, still leaves many HIE treated infants with lifelong disabilities. Furthermore, infants undergoing TH often require treatment for pain and agitation which may lead to further brain injury. For instance, morphine use in animal models has been shown to induce neuronal apoptosis. Dexmedetomidine is a potent α2-adrenergic receptor agonist that may be a better alternative to morphine for newborns with HIE treated with TH. Dexmedetomidine provides sedation, analgesia, and prevents shivering but does not suppress ventilation. Importantly, there is increasing evidence that dexmedetomidine has neuroprotective properties. Even though there are limited data on pharmacokinetics (PK), safety and efficacy of dexmedetomidine in infants with HIE, it has been increasingly administered in many centers. Objectives: To review the current approach to treatment of pain, sedation and shivering in infants with HIE undergoing TH, and to describe a new phase II safety and pharmacokinetics randomized controlled trial that proposes the use of dexmedetomidine vs. morphine in this population. Methods: This article presents an overview of the current management of pain and sedation in critically ill infants diagnosed with HIE and undergoing TH for 72 h. The article describes the design and methodology of a randomized, controlled, unmasked multicenter trial of dexmedetomidine vs. morphine administration enrolling 50 (25 per arm) neonates ≥36 weeks of gestation with moderate or severe HIE undergoing TH and that require pain/sedation treatment. Results and Conclusions: Dexmedetomidine may be a better alternative to morphine for the treatment of pain and sedation in newborns with HIE treated with TH. There is increasing evidence that dexmedetomidine has neuroprotective properties in several preclinical studies of injury models including ischemia-reperfusion, inflammation, and traumatic brain injury as well as adult clinical trials of brain trauma. The Dexmedetomidine Use in Infants undergoing Cooling due to Neonatal Encephalopathy (DICE) trial will evaluate whether administration of dexmedetomidine vs. morphine is safe, establish dexmedetomidine optimal dosing by collecting opportunistic PK data, and obtain preliminary neurodevelopmental data to inform a large Phase III efficacy trial with long term neurodevelopment impairment as the primary outcome.

Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial.

BACKGROUND: Exogenous surfactants to treat respiratory distress syndrome (RDS) are approved for tracheal instillation only; this requires intubation, often followed by positive pressure ventilation to promote distribution. Aerosol delivery offers a safer alternative, but clinical studies have had mixed results. We hypothesized that efficient aerosolization of a surfactant with low viscosity, early in the course of RDS, could reduce the need for intubation and instillation of liquid surfactant. METHODS: A prospective, multicenter, randomized, unblinded comparison trial of aerosolized calfactant (Infasurf) in newborns with signs of RDS that required noninvasive respiratory support. Calfactant was aerosolized by using a Solarys nebulizer modified with a pacifier adapter; 6 mL/kg (210 mg phospholipid/kg body weight) were delivered directly into the mouth. Infants in the aerosol group received up to 3 treatments, at least 4 hours apart. Infants in the control group received usual care, determined by providers. Infants were intubated and given instilled surfactant for persistent or worsening respiratory distress, at their providers' discretion. RESULTS: Among 22 NICUs, 457 infants were enrolled; gestation 23 to 41 (median 33) weeks and birth weight 595 to 4802 (median 1960) grams. In total, 230 infants were randomly assigned to aerosol; 225 received 334 treatments, starting at a median of 5 hours. The rates of intubation for surfactant instillation were 26% in the aerosol group and 50% in the usual care group (P < .0001). Respiratory outcomes up to 28 days of age were no different. CONCLUSIONS: In newborns with early, mild to moderate respiratory distress, aerosolized calfactant at a dose of 210 mg phospholipid/kg body weight reduced intubation and surfactant instillation by nearly one-half.

Neonates with suspected microangiopathic disorders: performance of standard manual schistocyte enumeration vs. the automated fragmented red cell count.

OBJECTIVES: To enhance the diagnosis of schistocyte-producing conditions, we compared routine manual schistocyte enumeration with automated fragmented red cell counts (FRCs). STUDY DESIGN: In neonates "suspected" of having sepsis, NEC, or DIC we compared manual schistocyte estimates vs. automated FRC counts. When the two disagreed, we used a "gold standard" from a  ≥ 1000 RBC differential. We also assessed the diagnostic accuracy of the FRC count in diagnosing sepsis, NEC, or DIC. RESULTS: We collected 270 CBCs from 90 neonates. The methods agreed in 63% (95% CI 55%-70%) of the CBCs. Among the 37% where they disagreed, the FRC count was more accurate in 100% (95% CI 88-100%). An elevated FRC count was specific for sepsis, and was sensitive and specific for necrotizing enterocolitis and DIC. CONCLUSIONS: Automated FRC counts have advantages over routine manual evaluation, larger sample size, lower expense, and superior accuracy in diagnosing schistocyte-producing conditions.

The potential of transdermal nitric oxide treatment for diabetic peripheral neuropathy and diabetic foot ulcers.

The Center for Disease Control (CDC) estimates that 29 million Americans have diabetes, and 70% of diabetic patients develop diabetic peripheral neuropathy [1,2]. Up to 27% of the direct medical cost of diabetes may be attributed to DPN [3]. A 2013 article from the American Diabetes Association reported a $176 billion direct medical cost of diabetes in 2012 [4]. DPN patients often suffer from shooting and burning pain in their distal limbs and a severe loss of sensation. Diabetic foot ulcers, infections, and amputations may follow. Currently available treatments: tricyclic antidepressants, anticonvulsants such as gabapentin and pregabalin, serotonin and norepinephrine reuptake inhibitor, duloxetine, topical 5% lidocaine (applied to the most painful area) can manage painful symptoms but do not address the underlying pathologies of DPN and diabetic wound ulcers. A combination of pain-reducing medications can provide relief when individual medications fail, and opioids such as tramadol and oxycodone may be administered with these medications to reduce pain [5]. Due to the prevalence of diabetes, DPN, and diabetic foot ulcers, and because of the lack of available effective treatments to directly address the pathology contributing to these conditions, novel treatments are being sought. Our hypothesis is that a deficiency of nitric oxide synthase in diabetic patients leads to a lack of vascularization of the peripheral nerves, which causes DPN; and this could be treated with vasodilators such as nitric oxide. In this paper, the mechanisms of DPN are reviewed and analyzed to elucidate the potential of a transdermal nitric oxide application for the treatment of DPN and diabetic wound ulcers by increasing vasodilation.

The Effect Of A Newborn Telehealth Program On Transfers Avoided: A Multiple-Baseline Study.

Clinicians who rarely perform neonatal resuscitation exhibit skill deterioration. Telehealth addresses this challenge by facilitating video connections between neonatologists at tertiary care centers and providers at smaller hospitals. However, there is little empirical evidence about the benefits of telehealth programs for neonatal resuscitation. Thus, we conducted a multiple-baseline study to evaluate the effect of video-assisted resuscitation on the transfer of newborns from eight community hospitals that implemented neonatal telehealth in the period November 2014-December 2015 to level 3 newborn intensive care units. The intervention was associated with a reduction of 0.70 transfers per facility-month and a 29.4 percent reduction in a newborn's odds of being transferred. Annually, this corresponds to 67.2 fewer transfers and an estimated savings of $1,220,352 per year. Avoiding transfers keeps families closer to home, increases community hospital revenue, and eliminates transfer-associated risk. Yet lack of reimbursement for telehealth limits its adoption. Policy changes are necessary to align payment incentives and promote the use of telehealth services.

Teleneonatology: a major tool for the future.

Hospitals have, for centuries, maintained a central position in the health care system, providing care for critically ill patients. Despite being a cornerstone of health care delivery, we are witnessing the beginning of a major transformation in their function. There are several forces driving this transformation, including health care costs, shortage of health care professionals, volume of people with chronic diseases, consumerism, health care reform, and hospital errors. The neonatal intensive care unit (NICU) at Utah Valley Regional Medical Center in Provo, Utah, began an aggressive redesign/quality improvement effort in 1990. It became obvious that our care processes were designed for health care deliverers and not for the families. An ongoing revamp of our care delivery processes was undertaken using significant input from a parent focus meeting, parental interviews, and development of a parent-to-parent support group. As a result of this work, it became obvious we needed a new model to truly empower parents. The idea of "NICU is Home" was born. We elected to make a mind shift, not to focus on what families think, but rather on how they think. Web cams and other video apparatus have been used in a number of NICUs across the country. We decided our equipment requirements would need to include high-resolution cameras, full high-definition video recording, autofocus, audio microphones, automatic noise reduction, and automatic low-light correction. Our conferencing software needed to accommodate multiple users and have multiple-picture capabilities, low band width, and inexpensive technology. It was recognized that a single video camera feed was insufficient to adequately capture the desired amount of information. Verbal communication between parents and their babies' principal care providers is critical. Parents loved the idea of expanding the remote NICU web cam of their baby to a two-way physician-parent communication bedside monitor. Doctors at Utah Valley Regional Medical Center now have a mobile desk using a WiFi computer/camera/audio to communicate with the family in real-time or leave a recording.

The Effectiveness of a Nationwide Intervention Programme to Prevent and Counter School Bullying in Ireland

The purpose of this paper is to set out what is known about (large-scale empirical research) and what has been done about (large-scale whole-school intervention programmes) bullying behaviour in Irish schools, with a view to indicating likely future developments in Irish anti-bullying action. Results from a 1993 nationwide representative survey of bullying behaviour in schools (O’Moore, Kirkham & Smith, 1997) are compared with those of a hitherto unpublished survey from 2004-2005 (the ‘ABC’ survey). Essentially, whilst the proportion of primary students involved in bully/victim problems was lower in the ‘ABC’ survey (35.3%) than it was in the 1993 nationwide survey (43.5%), the opposite was true for post-primary students (36.4% and 26.5% respectively). The background and methodology to two whole-school anti-bullying programmes in Ireland -one regional, the 1998-2000 Donegal Primary Schools Anti-Bullying Programme (O’ Moore & Minton, 2005), and one attempted nationwide initiative (the 2004-2006 ABC programme (Minton, 2007)- is presented, along with the programmes’ principal evaluation findings. Whilst the regional programme was evaluated as having produced statistically significant reductions in reports of having been bullied (19.6%), frequently bullied (50%), having bullied others (17.1%) and having frequently bullied others (69.2%) within the last three months (O’ Moore & Minton, 2005), the same levels of success were not obtained in the ABC programme initiative. A comparison of the implementation of the two programmes and a reflection on both contemporary and overall developments in the field of anti-bullying research and action in Ireland is undertaken, as indications for future directions are mapped out (AU)

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Operational evaluation of pulse oximetry in NICU patients with arterial access.

OBJECTIVE: To investigate pulse oximetry in neonates who require arterial access as represented by the clinical data recorded to manage their care. STUDY DESIGN: Analysis of simultaneous SpO(2) and SaO(2) from: 7-year historical NICU data (N=31905); 4-month prospective NICU data (N=566); verification data using two hemoximeters (N=52); and NICU data from two collaborating centers (N=95 and 168). The bias function (SpO(2)-SaO(2)) was regressed against the measured "gold" standard, SaO(2). RESULTS: A significant negative correlation was found for each of the data sets between the bias function and SaO(2). This bias was similar for devices from several manufacturers (Datex-Ohmeda, Masimo, Nellcor, and Spacelabs). Maximum operational performance occurred with peaks between 92 and 97% SaO(2), but declined markedly above and below this narrow range. In all, 71 to 95% of patients exhibited data with significant bias(.) CONCLUSION: These operational data suggest that with the methodology and devices currently in use, SpO(2) values in most all neonates who require arterial lines inaccurately correlate with measured arterial saturation.