Plos One
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Randomized Controlled Trial
Tracheal tubes lubricated with water to reduce sore throat after intubation: A randomized non-inferiority trial.
Sore throat is common after tracheal intubation. Water can be used to lubricate tracheal tubes, but its benefit has not been validated. We thus did a randomised non-inferiority trial to test the hypothesis that a tube lubricated with water does not reduce sore throat after tracheal intubation. ⋯ The tube lubricated with water did not reduce sore throat and pharyngeal injury after tracheal intubation compared to the tube without lubrication.
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Randomized Controlled Trial Multicenter Study
Low-molecular-weight heparin venous thromboprophylaxis in critically ill patients with renal dysfunction: A subgroup analysis of the PROTECT trial.
There is concern about excessive bleeding when low-molecular-weight heparins (LMWHs) are used for venous thromboembolism (VTE) prophylaxis in renal dysfunction. Our objective was to evaluate whether LMWH VTE prophylaxis was safe and effective in critically ill patients with renal dysfunction by conducting a subgroup analysis of PROTECT, a randomized blinded trial. ⋯ In critically ill patients with ESRD, or severe renal dysfunction, there was no significant difference in any VTE or major bleeding between UFH and dalteparin. Patients with severe renal dysfunction who received dalteparin had more proximal DVTs than those on UFH; this finding did not hold in patients with ESRD alone.
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Randomized Controlled Trial Multicenter Study
Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial.
Modified Vaccinia Ankara (MVA) is a live, viral vaccine under advanced development as a non-replicating smallpox vaccine. A randomised, double-blind, placebo-controlled phase III clinical trial was conducted to demonstrate the humoral immunogenic equivalence of three consecutively manufactured MVA production lots, and to confirm the safety and tolerability of MVA focusing on cardiac readouts. ⋯ The neutralizing and total antibody titers induced by each of the three lots were equivalent. No significant safety concerns emerged in this healthy trial population, especially regarding cardiac safety, thus confirming the excellent safety and tolerability profile of MVA.
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Randomized Controlled Trial
Exclusive breastfeeding promotion and neuropsychological outcomes in 5-8 year old children from Uganda and Burkina Faso: Results from the PROMISE EBF cluster randomized trial.
The beneficial effects from exclusive breastfeeding (EBF) have been widely acknowledged. We assessed the effect of exclusive breastfeeding promotion by peer counsellors in Uganda and Burkina Faso, on cognitive abilities, social emotional development, school performance and linear growth among 5-8 years old children. ⋯ Peer promotion for exclusive breastfeeding in Burkina Faso and Uganda was not associated with differences at 5-8 years of age in a range of measures of child development: cognitive abilities, emotion-behaviour-social symptoms or linear growth. This study from sub Saharan Africa did not reconfirm findings elsewhere that have shown an association between exclusive breastfeeding and cognitive performance. This might be due to a number of methodological limitations inherent in the current study. For example since the majority of the children were breastfed, the benefits of the intervention could have been diluted. Other factors such as the mental and HIV status of the mothers (which were not assessed in the current study) could have affected our results. Hence regarding the effect of exclusive breastfeeding on measures of child neurocognitive development in sub Saharan Africa, the jury is still out.
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Randomized Controlled Trial
Association between six-minute walk distance and long-term outcomes in patients with pulmonary arterial hypertension: Data from the randomized SERAPHIN trial.
Patients with pulmonary arterial hypertension who achieve a six-minute walk distance of 380-440 m may have improved prognosis. Using the randomized controlled trial of macitentan in pulmonary arterial hypertension (SERAPHIN), the association between six-minute walk distance and long-term outcomes was explored. ⋯ Patients with pulmonary arterial hypertension walking >400 m had better long-term prognosis. Although changes in six-minute walk distance were not associated with long-term outcomes, assessing absolute six-minute walk distance values remains important in the clinical management of patients with pulmonary arterial hypertension.