Objective To test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants. Design Prospective, phase IIb randomised, doubleblind, placebo-controlled trial. setting Seven level III-IV US, academic, neonatal intensive care units (NICUs). Patients Infants 24 0 -28 6 weeks' gestation (stratified 24 0 -26 6 ; 27 0 -28 6 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016. Interventions Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days. Main outcome measures The primary efficacy outcome was Ureaplasma-free survival. Secondary outcomes were all-cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support. results One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were Ureaplasma positive (azithromycin: n=19; placebo: n=25). Ureaplasma-free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma-colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract Ureaplasma colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract Ureaplasma colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants. Conclusion A 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study. Trial registration number NCT01778634.
We found that increasing birth GA was a significant predictor of failure, and that late-preterm infants comprised a significant percentage of infants who failed. This suggests that limiting testing to extremely premature infants would miss most cases of ICSC failure.
Rationale One possible basis for the proclivity of ethanol and nicotine co-abuse is an interaction between the discriminative stimulus (SD) effects of each drug. Objectives The current work sought to assess the discriminative control of ethanol and nicotine cues in mice trained with drug mixtures and to determine whether interactive mechanisms of overshadowing and potentiation occur. Methods Male C57BL/6J mice were trained to discriminate ethanol (1.5 g/kg) alone or ethanol plus nicotine (0.4, 0.8 or 1.2 mg/kg base) in experiment 1, and nicotine (0.8 mg/kg) alone or nicotine plus ethanol (0.5, 1.0 or 2.0 g/kg) in experiment 2. Stimulus generalization of the training mixtures to ethanol, nicotine and the drug combination were assessed. Results Ethanol (1.5 g/kg) retained discriminative control despite the inclusion of a progressively larger nicotine dose within the training mixtures in experiment 1. Although the nicotine SD was overshadowed by ethanol training doses > 0.5 g/kg in experiment 2, nicotine did potentiate the effects of low dose ethanol. Conclusions These findings are suggestive of dual mechanisms whereby ethanol (>0.5 g/kg) overshadows the SD effects of nicotine, and at lower doses (< 1 g/kg) the salience of ethanol’s SD effects is potentiated by nicotine. These mechanisms may contribute to the escalation of concurrent drinking and smoking in a binge-like fashion.
Background The American Academy of Pediatrics (AAP) recommends that all preterm neonates undergo a period of observation in a car safety seat before discharge, known as the Infant Car Seat Challenge (ICSC), to monitor for respiratory immaturity and the risk of adverse cardiopulmonary events in the upright position. However, no universal guidelines exist to define appropriate cutoffs for failure of the ICSC. We sought to evaluate regional neonatal intensive care unit (NICU) implementation of the ICSC and to evaluate variation in failure criteria. Methods We contacted level II and III nurseries/NICUs in New York/New England (n = 119) to determine if each per formed ICSCs, their inclusion criteria, duration of testing, and failure criteria. Results We contacted 119 institutions and had an 87% response rate (n = 103). Of the institutions that responded, 89% (n = 89) perform ICSCs. Of these 89 with current protocols, 17% did not follow AAP guidelines to test all neonates born <37 weeks’ gestation, and 45% did not follow guidelines for test duration. Despite wide variation, most units use thresholds for bradycardia of <80 bpm and desaturation of <90% to determine failure. Conclusions Despite AAP guidelines, implementation of ICSCs for preterm neonates is not universal in the region studied. Variation in definition of ICSC failure means that neonates are receiving differential care, not on the basis of their clinical characteristics, but on which institution performs the test. We propose standardizing the test to all infants born at <37 weeks’ gestation to a duration of at least 90 minutes, along with a failure threshold for bradycardia of <80 bpm for >10 seconds, and for saturation <90% for >10 seconds.
Recent studies have revealed an association between complicated grief-a severe, prolonged response to the loss of a loved one-and complicated spiritual grief-a spiritual crisis following loss. Furthermore, bereavement research has benefitted from a number of studies using qualitative inquiry as a means of examining the experiences of individuals grieving a variety of types of losses. However, a gap in the literature remains in terms of the qualitative investigation of spiritual struggle following loss. Thus, using participants' written responses to open-ended questions along with systematic exploration of this topic with a five-member focus group, we designed this qualitative study to better understand the firsthand experiences of bereaved individuals who have suffered a crisis of faith after the death of a loved one. Specifically, our directed content analysis of bereaved focus group members' responses revealed 17 different common and salient themes subsumed in an overarching narrative of resentment and doubt toward God, dissatisfaction with the spiritual support received, and substantial changes in the bereaved person's spiritual beliefs and behaviors. Thus, our study clarified the construct of complicated spiritual grief, and laid the groundwork for development of more specific assessment and treatment of this condition.
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