SUMMARY BackgroundThe herbal treatment with myrrh, dry extract of chamomile flowers and coffee charcoal has anti-inflammatory and antidiarrhoeal potential and might benefit patients with UC. Aminosalicylates are used as standard treatment for maintaining remission in ulcerative colitis (UC).
Background Pulmonary hypertension is a deadly complication of bronchopulmonary dysplasia, the most common pulmonary morbidity of prematurity. Despite these catastrophic consequences, no evidence-based therapies are available for the prevention of pulmonary hypertension in this population. Sildenafil is a potent pulmonary vasodilator approved by the US Food and Drug Administration for the treatment of pulmonary hypertension in adults. Preclinical models suggest a beneficial effect of sildenafil on premature lungs through improved alveolarization and preserved vascular development. Sildenafil may therefore prevent the development of pulmonary hypertension associated with lung disease of prematurity by reducing pulmonary vascular remodeling and lowering pulmonary vascular resistance; however, clinical trial evidence is needed. The present study, supported by the National Institutes of Health’s National Heart Lung and Blood Institute, will generate safety, pharmacokinetics, and preliminary effectiveness data on sildenafil in a population of premature infants with severe bronchopulmonary dysplasia at risk for pulmonary hypertension. Methods We have designed a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety trial of sildenafil in premature infants with severe bronchopulmonary dysplasia. We will randomize 120 premature infants < 29 weeks gestational age with severe bronchopulmonary dysplasia at 32–40 weeks postmenstrual age in a dose-escalating approach 3:1 (sildenafil: placebo) sequentially into each of 3 cohorts at ~ 30 clinical sites. Participants will receive up to 34 days of study drug, followed by 28 days of safety monitoring. The primary outcome will be safety as determined by incidence of hypotension. Secondary outcomes will include pharmacokinetics and preliminary effectiveness of sildenafil based on presence or absence of pulmonary hypertension diagnosed by echocardiography at the end of treatment period. Discussion Sildenafil is a promising intervention to prevent the development of pulmonary hypertension in premature infants with bronchopulmonary dysplasia. Clinical trials of sildenafil specifically designed for premature infants are urgently needed. The current study will make substantial contributions to scientific knowledge of the safety of sildenafil in premature infants at risk for pulmonary hypertension. Results from the study will be used by investigators to inform the design of a pivotal efficacy trial. Trial registration ClinicalTrials.govNCT04447989. Registered 25 June 2020.
Plant phenology, i. e. the timing of life cycle events, is related to individual fitness and species distribution ranges. Temperature is one of the most important drivers of plant phenology together with day length. The adaptation of their phenology may be important for the success of invasive plant species. The present study aims at understanding how the performance and the phenology of the invasive legume Lupinus polyphyllus vary with latitude. We sampled data across a >2000 km latitudinal gradient from Central to Northern Europe. We quantified variation in phenology of flowering and fruiting of L. polyphyllus using >1600 digital photos of inflorescences from 220 individual plants observed weekly at 22 sites. The day of the year at which different phenological phases were reached, increased 1.3–1.8 days per degree latitude, whereas the growing degree days (gdd) required for these phenological phases decreased 5–16 gdd per degree latitude. However, this difference disappeared, when the day length of each day included in the calculation of gdd was considered. The day of the year of the earliest and the latest climatic zone to reach any of the three studied phenological phases differed by 23–30 days and temperature requirements to reach these stages differed between 62 and 236 gdd. Probably, the invasion of this species will further increase in the northern part of Europe over the next decades due to climate warming. For invasive species control, our results suggest that in countries with a large latitudinal extent, the mowing date should shift by ca. one week per 500 km at sites with similar elevations.
Objective The study aimed to better understand how neonatology and maternal fetal medicine (MFM) physicians convey information during antenatal counseling that requires facilitating shared decision-making with parents facing options of resuscitation versus comfort care after extremely early delivery Study Design Attending physicians at US centers with both Neo and MFM fellowships were invited to answer an original online survey about antenatal counseling for extremely early newborns. The survey assessed information conveyed, processes for facilitating shared decision-making (reported separately), and clinical experiences. Neonatology and MFM responses were compared. Multivariable logistic regression analyzed topics often and seldom discussed by specialty groups with respect to respondents' clinical experience and resuscitation option preferences at different gestational weeks. Results In total, 74 MFM and 167 neonatologists representing 94% of the 81 centers surveyed responded. Grouped by specialty, respondents were similar in counseling experience and distribution of allowing choices between resuscitation and no resuscitation for delivery at specific weeks of gestational ages. MFM versus neonatology reported similar rates of discussing long-term health and developmental concerns and differed in all other categories of topics. Neonatologists were less likely than MFM to discuss caregiver impacts (odds ratio [OR]: 0.14, 95% confidence interval [CI]: 0.11–0.18, p < 0.001) and comfort care details (OR: 0.19, 95% CI: 0.15–0.25, p < 0.001). Conversely, neonatology versus MFM respondents more frequently reported “usually” discussing topics pertaining to parenting in the NICU (OR: 1.5, 95% CI: 1.2–1.8, p < 0.001) and those regarding stabilizing interventions in the delivery room (OR: 1.8, 95% CI: 1.4–2.2, p < 0.001). Compared with less-experienced respondents, those with 17 years’ or more of clinical experience had greater likelihood in both specialties to say they “usually” discussed otherwise infrequently reported topics pertaining to caregiver impacts. Conclusion Parents require information to make difficult decisions for their extremely early newborns. Our findings endorse the value of co-consultation by MFM and neonatology clinicians and of trainee education on antenatal consultation education to support these families. Key Points
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