Towards a GDPR-compliant cloud architecture with data privacy controlled through sticky policies.

Data privacy is one of the biggest challenges facing system architects at the system design stage. Especially when certain laws, such as the General Data Protection Regulation (GDPR), have to be complied with by cloud environments. In this article, we want to help cloud providers comply with the GDPR by proposing a GDPR-compliant cloud architecture. To do this, we use model-driven engineering techniques to design cloud architecture and analyze cloud interactions. In particular, we develop a complete framework, called MDCT, which includes a Unified Modeling Language profile that allows us to define specific cloud scenarios and profile validation to ensure that certain required properties are met. The validation process is implemented through the Object Constraint Language (OCL) rules, which allow us to describe the constraints in these models. To comply with many GDPR articles, the proposed cloud architecture considers data privacy and data tracking, enabling safe and secure data management and tracking in the context of the cloud. For this purpose, sticky policies associated with the data are incorporated to define permission for third parties to access the data and track instances of data access. As a result, a cloud architecture designed with MDCT contains a set of OCL rules to validate it as a GDPR-compliant cloud architecture. Our tool models key GDPR points such as user consent/withdrawal, the purpose of access, and data transparency and auditing, and considers data privacy and data tracking with the help of sticky policies.

The Use of Dexmedetomidine in Preterm Infants: A Single Academic Center Experience.

OBJECTIVE: Preterm newborns (PTNBs) often require sedation and analgesia. Dexmedetomidine (DEX) is used to provide sedation in extremely PTNBs, even though information on such use is limited. The objective of this research is to describe the use of DEX in these patients in a single academic center. METHODS: This is a retrospective study of PTNBs receiving DEX from January 1, 2010, through December 31, 2018, at the Cleveland Clinic Children's Hospital, a tertiary academic center operating 2 Level III and 1 Level IV neonatal intensive care units (NICUs). Inclusion criteria were gestational age (GA) <36 weeks and receipt of DEX for >2 days. Adequacy of clinical response was based on achieving Neonatal Pain, Agitation and Sedation Scale (N-PASS) scores <3. Hypotension, bradycardia, and respiratory depression were recorded as the incidence as adverse events. RESULTS: A total of 105 patients were included. The birth weight median was 870 g (IQR, 615-1507); the GA median was 26 weeks (IQR, 24-31). The duration of DEX infusion averaged 7 days. The DEX dose averaged 0.4 mcg/kg (IQR, 0.3-0.45). Bradycardia was observed in 35 patients (57%) weighting <1 kg and in 7 patients (18%) >1 kg (p < 0.01). There was no difference in the incidence of other adverse events between these groups. However, infants <1 kg required more pharmacologic interventions to maintain N-PASS score <3. CONCLUSIONS: DEX was well tolerated overall and provided adequate sedation to PTNBs in this cohort. From this study, we recommend a starting dose of 0.2 to 0.4 mcg/kg/hr and titrating up hourly until adequate sedation is achieved.

Dexmedetomidine for the Management of Postoperative Pain and Sedation in Newborns.

BACKGROUND: Opioids and benzodiazepines have been the mainstay of neonatal analgesia and sedation. However, based on evidence in neonatal animals, these drugs may be deleterious for the developing brain. Dexmedetomidine (DEX), a central alpha-2 agonist, has sedative and analgesic effects and has been shown to be neuroprotective in animal models. Despite increasing use of DEX in newborns, there is a paucity of data regarding its safety and efficacy in this population. OBJECTIVES: The impact of using DEX in postsurgical neonates, either alone or with opioid infusions, for sedation/analgesia was evaluated. The cumulative dose of opioids among patients who did or did not receive DEX was calculated to examine the hypothesis that the addition of DEX can reduce the patient exposure to opioids without significantly increasing side effects and providing adequate sedation and pain control. METHODOLOGY: This was a retrospective cohort study in which patients were matched by postnatal age and surgical procedure into 2 groups. One group received DEX in the regimen for treatment of pain or sedation after a surgical procedure, and the other group received no DEX. Episodes of bradycardia, respiratory depression and hypotension, and the cumulative dose of opioids and number of supplemental doses administered in both groups were documented. RESULTS: Although there was no difference in gestational age or weight at birth between the DEX and no-DEX groups, the DEX group's median postconceptional date was older at the time of surgery (39.6 vs 37.4 weeks; p = 0.003). Patients in the DEX group experienced more episodes of bradycardia (12.8% vs 5.1%; p = 0.01). There was no difference between groups in episodes of hypotension or respiratory depression. The cumulative dose of opioids was significantly lower in the DEX group compared with the no-DEX group (1155 mcg/kg vs 1841 mcg/kg; p = 0.01). There was no difference in the number of supplemental doses of opioids given between the groups. CONCLUSIONS: The addition of DEX to opioid infusions resulted in a significant decrease in the cumulative dose of opioids but was associated with more episodes of bradycardia than opioids alone.

Comparison of Biphasic vs Static Oxygen Saturation Targets Among Infants With Retinopathy of Prematurity.

Importance: The Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) demonstrated that static low oxygen saturation decreased retinopathy of prematurity (ROP) but increased mortality compared with static high oxygen saturation cohorts. Objective: To compare outcomes of a biphasic oxygen protocol with static targets recommended by SUPPORT. Design, Setting, and Participants: Retrospective cohort study comparing biphasic vs static standards 41 months prior to and 42 months after a change from biphasic to static SUPPORT standards at a level III neonatal intensive care unit (Fairview Hospital, Cleveland, Ohio). The study included infants born at a corrected gestational age (CGA) of 31 weeks or younger or birth weight 1500 g or less. Data were analyzed between August 2010 and July 2017. Interventions: The pre-SUPPORT group underwent biphasic protocol target saturations of 85% to 92% at younger than 34 weeks' CGA and greater than 95% at 34 weeks' CGA or older. The post-SUPPORT group underwent a constant 91% to 95% target. Main Outcomes and Measures: Primary outcome was incidence of type 1 ROP. Secondary outcomes were incidence of any ROP, time to full vascularization, and mortality. Results: Of 596 eligible infants, 562 were included in ophthalmic analysis. Three hundred three patients were boys (54%); 399 were white (71%), 87 were black (15%), and 76 were of other or unknown race/ethnicity (14%). Mean (SD) CGA and birth weight were 29 (2) weeks and 1151 (346) g, respectively. Any ROP overall increased (53 [20%] pre-SUPPORT vs n = 86 [28%] post-SUPPORT; absolute difference, 8%; 95% CI, 1%-15%; odds ratio, 1.6; 95% CI, 1.05-2.3; P = .03). Type 1 ROP increased in the post-SUPPORT era (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; odds ratio, 2.7; 95% CI, 1.05-6.9; P = .03). There was a delay in vascularization in the post-SUPPORT group (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; P = .03). Conclusions and Relevance: Compared with static oxygen standards, biphasic oxygen targets are associated with decreased incidence and severity of ROP without increasing mortality.

Neural breathing pattern in newborn infants pre- and postextubation.

AIM: To describe the neural breathing pattern before and after extubation in newborn infants. METHODS: Prospective, observational study. In infants deemed ready for extubation, the diaphragm electrical activity (EAdi) was continuously recorded from 30 minute before to two hours after extubation. RESULTS: Total of 25 neonates underwent 29 extubations; 10 extubations resulted in re-intubation within 72 hours. Postextubation, there was an increase in peak EAdi (EAdi-max) and EAdi-delta (peak minus minimum EAdi) in both groups. The pre- to postextubation change in EAdi-max (8.9-11.1 µv) and EAdi-delta (6-8 µv) was less in the failure group in comparison with the change in EAdi-max (10.2-13.4 µv) and EAdi-delta (6.3-10.6 µv) in the success group, (p = 0.02 and 0.01, respectively). CONCLUSION: In our neonatal cohort, extubation failure was associated with a smaller increase in peak and delta EAdi after extubation. If confirmed, these findings indicate an important cause of extubation failure in preterm infants.

The Use of Gabapentin for Pain and Agitation in Neonates and Infants in a Neonatal ICU.

OBJECTIVES: Limited data support how to safely and effectively treat refractory pain and agitation in neonates and infants. Gabapentin has been used in this patient population and has shown promising results, yet there is still a paucity of data about its clinical efficacy. There is a need for a larger evaluation to determine its effectiveness. This study describes one institution's experience with gabapentin for the treatment of refractory pain and agitation in the neonatal intensive care unit (NICU). METHODS: This was a retrospective, observational evaluation of patients who received gabapentin in the level IV NICU at the Cleveland Clinic Children's Hospital. Changes in neonatal pain, agitation, and sedation scale (N-PASS) scores and analgesic and sedative medication requirements were analyzed, as were gabapentin dose requirements and adverse reactions. RESULTS: Between January 2012 and November 2015, 22 patients received gabapentin and were included in this study. The average gabapentin starting dose was 10.2 mg/kg/day, with maximum doses up to 25.5 mg/kg/day. The median N-PASS score at gabapentin therapy initiation was 3.1 and after gabapentin initiation the last N-PASS score documented was 0 in all but 5 patients. Gabapentin use reduced the need for analgesic or sedative medications. The drug was well tolerated, and only 1 patient experienced an adverse reaction to gabapentin (i.e., nystagmus). CONCLUSIONS: Gabapentin was well tolerated and associated with decreases in pain scores. It's use resulted in decreased requirements for analgesic and sedative medications. Gabapentin therapy appears to be an effective option for neonates and infants with refractory pain and agitation.

Quantitative ultrasound in the evaluation of bone status in premature and full-term infants.

Metabolic bone disease of prematurity (MBDP) is a common and significant problem that often gives rise to osteopenia, fractures, osteomalacia, and osteoporosis. The purpose of our study is to establish normative data on bone status in premature and full-term infants to help future studies on MBDP. Bone status was prospectively determined as part of a multicenter study among newborns within 96 hours of life. The patients were divided into 2 groups: group 1 included those neonates 25-36 wk gestational age (premature), and group 2 neonates were born at 37-42 wk gestational age (full term). Demographic data were collected. The Omnisense 7000 Bone Sonometer (Sunlight Medical Ltd., Tel-Aviv, Israel) was used to determine the speed of sound (SOS) through the mid tibia, which reflects bone strength. A total of 235 patients were enrolled in this study. Group 1 (i.e., the premature infants) had a statistically lower age-adjusted SOS as compared with group 2 (i.e., the full-term infants) (analysis of variance; p=0.001). There was also a correlation between SOS and birth weight (r=0.3; p<001). This study represents the largest database of normative data for bone status measuring in preterm and term infants.

Evoked electromyographic technique for quantitative assessment of the innervation status of laryngeal muscles.

OBJECTIVES: The purpose of this study was to develop a minimally invasive, noninjurious evoked electromyographic technique that could accurately quantitate the level of innervation of laryngeal muscles with recurrent laryngeal nerve stimulation. METHODS: A four-phase study was conducted in 24 canines, including 1) identification of the best stimulation-recording configuration, 2) statistical analysis of sensitivity and accuracy, 3) evaluation of safety, and 4) identification of the laryngeal muscle(s) that contribute to the evoked response. RESULTS: The results demonstrated that an entirely noninvasive technique is not feasible. The stimulating cathode must be invasive to ensure discrete activation of the recurrent laryngeal nerve, whereas both recording electrodes should remain on the surface with one overlying the thyroid ala. This configuration proved to be highly accurate, with an error rate of only 6% to 7%, and with sensitivity sufficient to detect a signal in a nerve with fewer than 1% of the axons intact. There was no evidence of nerve injury in any animal over the course of 350 stimulus needle penetrations. By use of neuromuscular blockade to identify those muscles generating the surface response, the thyroarytenoid muscle was found to be the primary contributor, whereas the posterior cricoarytenoid muscle was uninvolved. CONCLUSIONS: This evoked electromyographic technique could provide quantitative information regarding the extent of muscle innervation during denervation and regeneration in case of laryngeal paralysis.

Management of respiratory distress syndrome: an update.

Respiratory distress syndrome is the most common respiratory disorder in preterm infants. Over the last decade, because of improvements in neonatal care and increased use of antenatal steroids and surfactant replacement therapy, mortality from respiratory distress syndrome has dropped substantially. However, respiratory morbidity, primarily bronchopulmonary dysplasia, remains unacceptably high. The management of respiratory distress syndrome in preterm infants is based on various modalities of respiratory support and the application of fundamental principles of neonatal care. To obtain best results, a multidisciplinary approach is crucial. This review discusses surfactant replacement therapy and some of the current strategies in ventilatory management of preterm infants with respiratory distress syndrome.

Electrical stimulation of a denervated muscle promotes selective reinnervation by native over foreign motoneurons.

The effect of electrical stimulation of the denervated posterior cricoarytenoid (PCA) muscle on its subsequent reinnervation was explored in the canine. Eight animals were implanted with a planar array of 36 electrodes for chronic stimulation and recording of spontaneous and evoked electromyographic (EMG) potentials across the entire fan-shaped surface of a muscle pair. Normative EMG data were recorded from each electrode site before unilateral nerve section, and from the innervated partner after nerve section. After randomizing the animals to experimental and control groups, the right recurrent laryngeal nerve innervating the PCA abductor muscle and its adductor antagonists was sectioned and reanastomosed. The PCA muscle in four experimental animals was continuously stimulated during the 11-mo experiment, using a 1-s, 30-pps, biphasic pulse train composed of 1-ms pulses 2-6 mA in amplitude and repeated every 10 s. The remaining four animals served as nonstimulated controls. Appropriate reinnervation by native inspiratory motoneurons was indexed behaviorally by the magnitude of vocal fold opening and electromyographically by the potential across all electrode sites. Inappropriate reinnervation by foreign adductor motoneurons was quantitated by recording EMG potentials evoked reflexly by stimulation of sensory afferents of the laryngeal mucosa. All four experimental animals showed a greater level of correct PCA muscle reinnervation (P < 0.0064) and a lesser level of incorrect reinnervation (P < 0.0084) than the controls. Direct muscle stimulation also appeared to enhance the overall magnitude of reinnervation, but the effect was not as strong (P < 0.113). These findings are consistent with a previous report and suggest that stimulation of a mammalian muscle may profoundly affect its receptivity to reinnervation by a particular motoneuron type.

Papillon-Lefevre syndrome: a case report and review of the literature

Papillon-Lefevre syndrome is a rare autosomal recessive syndrome associated with palmoplantar keratoderma and early onset periodontal disease that results in loss of the teeth. Actinomyces Actinomycetemcomitans causing periodontal damage, and alterations in the polymorphonuclear leukocyte function have been postulated or probable pathogenetic mechanism. Early recognition of this entity as well as a multidisciplinary management may help in the prognosis of these cases