BackgroundIt had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission.MethodsThe protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality.DiscussionThis will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.Trial registrationClinicalTrials.gov, ID: NCT02845843. Registered on 27 July 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.
Background Each year nearly 7.7 million children under five years die around the world; out of which approximately 3.1 million of the newborns die during the neonatal period and almost all these (99%) deaths occur in the developing countries. According to the World Health Organization’s estimation neonatal deaths account for 45% of the under-five deaths. More than one-third of these deaths occur in the first 24 h of birth, whereas three-quarter of the neonatal deaths takes place in the first seven days of birth. The purpose of this study is to assess the knowledge, attitude, and practices (KAP) among mothers about newborns’ care and its related factors in district Badin Sindh province of Pakistan. Methods A community-based cross-sectional study was conducted from July 2017 to August 2017 to assess the Knowledge, Attitude, and Practices (KAP) in mothers regarding newborn care. A structured questionnaire was administered, after pretest, for data gathering through face to face interview. All survey participants were identified using multi-stage cluster sampling. A scoring system was used to calculate the level of KAP among participants. Independent sample t-test, ANOVA, and GLM were applied to identify the statistical difference between the means of various groups. Result A total of 518 survey participants were interviewed. Among the study sample, more than half of the newborns were bathed within six hours of delivery. Around 50% started breastfeeding after 1 h of birth. A substantial proportion (45%) of mothers gave pre-lacteal feeding and 44.8% of them did not feed colostrum to their newborns. Among those who administered pre-lacteal to their newborn babies included animal/formula milk (15.4%), honey (24.5%) and fresh butter/ghee (5.2. %). Mothers with no education had less significant KAP score about newborn care as compared to those who had higher education ( p < 0.05). Conclusion This study revealed that high-risk factors such as immediate bathing, application of traditional substances on the cord, delayed initiation of breastfeeding, discarding colostrum and giving pre-lacteal feed to newborns were highly prevalent. This requires urgent attention of Maternal, Newborn and Child Health (MNCH) programs and health care delivery system to prevent harmful care practices and adopt healthy practices especially in the rural settings.
BackgroundThere is little data surrounding the survival of patients with chronic obstructive pulmonary disease (COPD) who are admitted to the critical care unit with exacerbation of symptoms. We conducted a study to measure the in-hospital and intensive care unit (ICU) outcomes of patients admitted with COPD exacerbation, and identified the related prognostic factors.MethodWe performed a retrospective cohort study of patients who were admitted to the adult ICU between January 2006 and July 2011 for COPD exacerbation in King Abdulaziz National Guard Hospital, Al-Hasa, Saudi Arabia.ResultsDuring the study period, a total of 119 patients were admitted to the ICU with acute respiratory failure attributed to COPD exacerbation. The mean age was 72 ± 13 years, and 44 (37%) were females. The main cause of respiratory failure was infection, which occurred in 102 (86%) patients. Thirty-nine (33%) of the admitted patients were mechanically ventilated, and the median duration was 2.6 (1–42) days. The median lengths of the ICU and hospital stays were 3 (1–40) and 9 (2–43) days, respectively. The ICU mortality was 6%, and hospital mortality was 11%. Low Glasgow Coma Scale on admission, intubation, duration of mechanical ventilation, current smoking, tracheostomy, cardiopulmonary arrest, and the development of acute renal failure were associated with higher hospital mortality.ConclusionEarly ICU and hospital mortality is low for COPD patients who have been admitted to the ICU with exacerbation. Low Glasgow Coma Scale scores on admission, intubation, prolonged use of mechanical ventilation, and the development of acute renal failure were identified as risk factors associated with increased hospital mortality.
Summary Background To overcome the three delays in triage, transport and treatment that underlie adverse pregnancy outcomes, we aimed to reduce all-cause adverse outcomes with community-level interventions targeting women with pregnancy hypertension in three low-income countries. Methods In this individual participant-level meta-analysis, we de-identified and pooled data from the Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trials in Mozambique, Pakistan, and India, which were run in 2014–17. Consenting pregnant women, aged 12–49 years, were recruited in their homes. Clusters, defined by local administrative units, were randomly assigned (1:1) to intervention or control groups. The control groups continued local standard of care. The intervention comprised community engagement and existing community health worker-led mobile health-supported early detection, initial treatment, and hospital referral of women with hypertension. For this meta-analysis, as for the original studies, the primary outcome was a composite of maternal or perinatal outcome (either maternal, fetal, or neonatal death, or severe morbidity for the mother or baby), assessed by unmasked trial surveillance personnel. For this analysis, we included all consenting participants who were followed up with completed pregnancies at trial end. We analysed the outcome data with multilevel modelling and present data with the summary statistic of adjusted odds ratios (ORs) with 95% CIs (fixed effects for maternal age, parity, maternal education, and random effects for country and cluster). This meta-analysis is registered with PROSPERO, CRD42018102564. Findings Overall, 44 clusters (69 330 pregnant women) were randomly assigned to intervention (22 clusters [36 008 pregnancies]) or control (22 clusters [33 322 pregnancies]) groups. 32 290 (89·7%) pregnancies in the intervention group and 29 698 (89·1%) in the control group were followed up successfully. Median maternal age of included women was 26 years (IQR 22–30). In the intervention clusters, 6990 group and 16 691 home-based community engagement sessions and 138 347 community health worker-led visits to 20 819 (57·8%) of 36 008 women (of whom 11 095 [53·3%] had a visit every 4 weeks) occurred. Blood pressure and dipstick proteinuria were assessed per protocol. Few women were eligible for methyldopa for severe hypertension (181 [1%] of 20 819) or intramuscular magnesium sulfate for pre-eclampsia (198 [1%]), of whom most accepted treatment (162 [89·5%] of 181 for severe hypertension and 133 [67·2%] of 198 for pre-eclampsia). 1255 (6%) were referred to a comprehensive emergency obstetric care facility, of whom 864 (82%) accepted the referral. The primary outcome was similar in the intervention (7871 [24%] of 32 290 pregnancies) and control clusters (6516 [22%] of 29 698; adjusted OR 1·17, 95% CI 0·90–1·51; p=0·24). No intervention-related serious adverse events occurred, and few adver...
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