Hypothermic stunning of green sea turtles in a western Gulf of Mexico foraging habitat.

Texas waters provide one of the most important developmental and foraging habitats for juvenile green turtles (Chelonia mydas) in the western Gulf of Mexico, but hypothermic stunning is a significant threat and was the largest cause of green turtle strandings in Texas from 1980 through 2015; of the 8,107 green turtles found stranded, 4,529 (55.9%) were victims of hypothermic stunning. Additionally, during this time, 203 hypothermic stunned green turtles were found incidentally captured due to power plant water intake entrapment. Overall, 63.9% of 4,529 hypothermic stunned turtles were found alive, and 92.0% of those survived rehabilitation and were released. Numbers of green turtles recorded as stranded and as affected by hypothermic stunning increased over time, and were most numerous from 2007 through 2015. Large hypothermic stunning events (with more than 450 turtles documented) occurred during the winters of 2009-2010, 2010-2011, 2013-2014, and 2014-2015. Hypothermic stunning was documented between November and March, but peaked at various times depending on passage of severe weather systems. Hypothermic stunning occurred state-wide, but was most prevalent in South Texas, particularly the Laguna Madre. In the Laguna Madre, hypothermic stunning was associated with an abrupt drop in water temperatures strong northerly winds, and a threshold mean water temperature of 8.0°C predicted large turtle hypothermic stunning events. Knowledge of environmental parameters contributing to hypothermic stunning and the temporal and spatial distribution of turtles affected in the past, can aid with formulation of proactive, targeted search and rescue efforts that can ultimately save the lives of many affected individuals, and aid with recovery efforts for this bi-national stock. Such rescue efforts are required under the U.S. Endangered Species Act and respond to humanitarian concerns of the public.

Safety and efficacy results of the advanced renal cell carcinoma sorafenib expanded access program in North America.

BACKGROUND: The Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program made sorafenib available to patients with advanced renal cell carcinoma (RCC) before regulatory approval. METHODS: In this nonrandomized, open-label expanded access program, 2504 patients from the United States and Canada were treated with oral sorafenib 400 mg twice daily. Safety and efficacy were explored overall and in subgroups of patients including those with no prior therapy, nonclear cell (nonclear cell) RCC, brain metastases, prior bevacizumab treatment, and elderly patients. Sorafenib was approved for RCC 6 months after study initiation, at which time patients with no prior therapy or with nonclear cell RCC could enroll in an extension protocol for continued assessment for a period of 6 months. RESULTS: The most common grade > or =2 drug-related adverse events were hand-foot skin reaction (18%), rash (14%), hypertension (12%), and fatigue (11%). In the 1891 patients evaluable for response, complete response was observed in 1 patient, partial response in 67 patients (4%), and stable disease for at least 8 weeks in 1511 patients (80%). Median progression-free survival in the extension population was 36 weeks (95% confidence interval [CI], 33-45 weeks; censorship rate, 56%); median overall survival in the entire population was 50 weeks (95% CI, 46-52 weeks; censorship rate, 63%). The efficacy and safety results were similar across the subgroups. CONCLUSIONS: Sorafenib 400 mg twice daily demonstrated activity and a clinically acceptable toxicity profile in all patient subsets enrolled in the ARCCS expanded access program (clinicaltrials.gov identifier: NCT00111020).

Does umbilical cord care in preterm infants influence cord bacterial colonization or detachment?

OBJECTIVE: The purpose of the present study was to compare alcohol versus natural drying for umbilical cord care in preterm infants and to examine its effects on bacterial colonization and cord detachment. STUDY DESIGN AND METHODS: Eligible infants <34 weeks gestation admitted to the NICU were randomized to receive either umbilical cleansing with 70% isopropyl alcohol at each diaper change or natural drying. Umbilical stump cultures were performed at 12 to 24 hours, 72 hours, 7 days, and 14 days of age. RESULTS: A total of 109 infants were enrolled; 102 completed the study. Analyses revealed that the median cord detachment time was significantly shorter in the natural drying group compared to the alcohol group (13.0 versus 16.0 days; p=0.003). There were no cases of local umbilical infection in either group. CONCLUSION: Based on the present study, it appears that natural drying is a safe and effective means of umbilical cord care in preterm infants.

Evaluation and development of potentially better practices for the prevention of brain hemorrhage and ischemic brain injury in very low birth weight infants.

OBJECTIVE: Neonatal care providers from 5 institutions formed a multidisciplinary focus group with the purpose of identifying potentially better practices, the implementation of which would lead to a reduction in the incidence of intracranial hemorrhage and periventricular leukomalacia in very low birth weight infants. METHODS: Practices were analyzed, 4 benchmark neonatal intensive care units were identified and evaluated, and the literature was assessed using an evidence-based approach. The work was also reviewed by a nationally respected expert. RESULTS: Ten potentially better clinical practices were identified. In addition, variability in cranial ultrasound practice, related to both procedural process and interpretation, was identified as a confounding problem in evaluating quality. Using the same process, potentially better cranial ultrasound practices were also identified. CONCLUSIONS: Implementation of these practices will improve clinical outcomes as well as the reliability of sonogram interpretation, the basis for evaluating the quality of the team's work.

Implementation of potentially better practices for the prevention of brain hemorrhage and ischemic brain injury in very low birth weight infants.

OBJECTIVE: Using an evidence-based approach, a Vermont Oxford Network focus group whose goal was to reduce brain injury developed and implemented a number of potentially better practices. Each center approached implementation of the practices differently. Reducing the incidence of intraventricular hemorrhage and periventricular leukomalacia are important for improving long-term outcomes for low birth weight infants. METHODS: Implementation approaches for some but not all of the practices at the various centers are discussed. The practices reviewed include optimal peripartum management, such as resuscitation, avoidance of hypothermia, optimal surfactant delivery, early neonatal management by the most experienced providers, and measures to minimize pain and stress. Additional practices include maintenance of neutral head positioning, fluid volume therapy for hypotension, indomethacin prophylaxis, ventilator management, avoidance of routine suctioning, and limiting the use of sodium bicarbonate and postnatal dexamethasone. RESULTS: Approaches to implementation were center specific, and results vary. Although some practices were easier to implement than others, communication, education, and leadership were critical to the process. CONCLUSIONS: The quality improvement multidisciplinary approach is a useful tool for finding ways to reduce the incidence of intraventricular hemorrhage and periventricular leukomalacia.