scholarly journals Two-year outcomes after dextrose gel prophylaxis for neonatal hypoglycaemia

2020 ◽  
pp. fetalneonatal-2020-320305
Author(s):  
Rebecca Griffith ◽  
Joanne Elizabeth Hegarty ◽  
Jane M Alsweiler ◽  
Greg D Gamble ◽  
Robyn May ◽  
...  
Keyword(s):  
Executive Function ◽  
New Zealand ◽  
Relative Risk ◽  
Adverse Effects ◽  
Multiple Dose ◽  
Randomised Trial ◽  
Neonatal Hypoglycaemia ◽  
Health Measures ◽  
Secondary Outcomes

ObjectiveTo determine the effect of prophylactic dextrose gel for prevention of neonatal hypoglycaemia on neurodevelopment and executive function at 2 years’ corrected age.DesignProspective follow-up of a randomised trial.SettingNew Zealand.PatientsParticipants from the pre-hypoglycaemia Prevention with Oral Dextrose (pre-hPOD) trial randomised to one of four dose regimes of buccal 40% dextrose gel or equivolume placebo.Main outcome measuresCoprimary outcomes were neurosensory impairment and executive function. Secondary outcomes were components of the primary outcomes, neurology, anthropometry and health measures.ResultsWe assessed 360 of 401 eligible children (90%) at 2 years’ corrected age. There were no differences between dextrose gel dose groups, single or multiple dose groups, or any dextrose and any placebo groups in the risk of neurosensory impairment or low executive function (any dextrose vs any placebo neurosensory impairment: relative risk (RR) 0.77, 95% CI 0.50 to 1.19, p=0.23; low executive function: RR 0.50, 95% CI 0.24 to 1.06, p=0.07). There were also no differences between groups in any secondary outcomes. There was no difference between children who did or did not develop neonatal hypoglycaemia in the risk of neurosensory impairment (RR 1.05, 95% CI 0.68 to 1.64, p=0.81) or low executive function (RR 0.73, 95% CI 0.34 to 1.59, p=0.43).ConclusionProphylactic dextrose gel did not alter neurodevelopment or executive function and had no adverse effects to 2 years’ corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.

scholarly journals O-104 Two Year Outcomes Of Children Treated With Dextrose Gel For Neonatal Hypoglycaemia: Follow Up Of A Randomised Trial

2014 ◽  
Vol 99 (Suppl 2) ◽  
pp. A64.2-A65 ◽  
Author(s):  
DL Harris ◽  
PJ Weston ◽  
JM Alsweiler ◽  
B Thompson ◽  
T Wouldes ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Neonatal Hypoglycaemia

scholarly journals A multicentre randomised trial comparing octreotide and injection sclerotherapy in the management and outcome of acute variceal haemorrhage

Gut ◽  
1997 ◽  
Vol 41 (4) ◽  
pp. 526-533 ◽  
Author(s):  
S A Jenkins ◽  
R Shields ◽  
M Davies ◽  
E Elias ◽  
A J Turnbull ◽  
...  
Keyword(s):  
Relative Risk ◽  
Randomised Trial ◽  
Major Complication ◽  
Injection Sclerotherapy ◽  
Endoscopic Sclerotherapy ◽  
Trial Period ◽  
Variceal Haemorrhage ◽  
Acute Variceal Bleeding ◽  
To Receive

Background—Few studies have compared vasoactive drugs with endoscopic sclerotherapy in the control of acute variceal haemorrhage. Octreotide is widely used for this purpose, but its value remains undetermined.Aims—To compare octreotide with endoscopic sclerotherapy for acute variceal haemorrhage.Patients—Consecutive patients with acute variceal haemorrhage.Methods—Patients were randomised at endoscopy to receive either a 48 hour intravenous infusion of 50 μg/h octreotide (n=73), or emergency sclerotherapy (n=77).Results—Overall control of bleeding and mortality was not significantly different between octreotide (85%, 62 patients) and sclerotherapy (82%, 63 patients) over the 48 hour trial period (relative risk of rebleeding 0.83; 95% confidence interval (CI) 0.38 to 1.82), irrespective of Child’s grading or active bleeding at endoscopy. One major complication was observed in the sclerotherapy group (aspiration) and two in the octreotide group (pulmonary oedema, severe paralytic ileus). During 60 days of follow up there was an overall trend towards an increased mortality in the octreotide group which was not statistically significant (relative risk of dying at 60 days 1.91, 95% CI 0.97 to 3.78, p=0.06).Conclusions—The results of this study indicate that intravenous octreotide is as effective as injection sclerotherapy in the control of acute variceal bleeding, but further controlled trials are necessary to evaluate the safety of this treatment.

scholarly journals A chronic protocol of bilateral transcranial direct current stimulation over auditory cortex for tinnitus treatment: Dataset from a double-blinded randomized controlled trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 733 ◽  
Author(s):  
Ali Yadollahpour ◽  
Miguel Mayo ◽  
Nader Saki ◽  
Samaneh Rashidi ◽  
Arash Bayat
Keyword(s):  
Adverse Effects ◽  
Auditory Cortex ◽  
Direct Current ◽  
Transcranial Direct Current Stimulation ◽  
Therapeutic Potential ◽  
Controlled Trial ◽  
Direct Current Stimulation ◽  
Secondary Outcomes ◽  
Double Blinded

Preliminary studies have demonstrated the therapeutic potential of transcranial direct current stimulation (tDCS) for chronic tinnitus. However, the findings are controversial and most of the studies investigated effects of a single session of tDCS and short after-effects, ranging from hours to days. To our knowledge, there is no published study investigating the effects of a chronic protocol of bilateral tDCS over auditory cortex (AC) with one month follow-up in a double blinded randomized clinical trial. This dataset presents the results of a double-blinded placebo controlled trial investigating the effects of chronic protocol (10 sessions) of tDCS over AC with 1 month follow-up. The data of the two groups, real tDCS (n=25) and sham tDCS (n=15), are reported. The dataset includes three main data groups: patient- and tinnitus-specific data, data of the primary and secondary outcomes, and data on the adverse effects of and tolerability to tDCS. The first group includes demographic information, audiometric assessments, and tinnitus-specific characteristics. The second group includes tinnitus handicap inventory (THI) scores, tinnitus loudness, and tinnitus related distress based on 0-10 numerical visual analogue scale (VAS) scores. The values of the primary and secondary outcomes for pre-intervention and at different time points following interventions are presented. THI scores pre-intervention and immediately post-intervention and at 1 month follow-up; the scores of tinnitus loudness and distress scores for pre-intervention, and immediately, 1 hour, 1 week, and at 1 month after the last stimulation session are presented. Moreover, the adverse effects of and tolerability to the tDCS were assessed using a customized questionnaire after the last tDCS session. This dataset can be used alone or in combination with other datasets using advanced statistical analyses and modeling to investigate the treatment efficacy of tDCS in chronic intractable tinnitus.

Abstract 255: Electronic Health Record Alerts Decreased Non-Steroidal Anti-Inflammatory Drug Prescriptions in Patients With Congestive Heart Failure: A Quality Improvement Initiative

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Louis T Vincent ◽  
Mark Jacobs ◽  
neal olarte ◽  
Fahim Pyarali ◽  
Jonathan Salter ◽  
...  
Keyword(s):  
Heart Failure ◽  
Congestive Heart Failure ◽  
Quality Improvement ◽  
Relative Risk ◽  
Electronic Health Record ◽  
Health Record ◽  
Secondary Outcomes ◽  
Anti Inflammatory ◽  
Electronic Health

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are associated with increased morbidity and mortality in patients with congestive heart failure (CHF). Current guidelines recommend discontinuation of NSAIDs in all patients with CHF, but in clinical practice, many patients remain with active prescriptions. We sought to reduce prevalence of active NSAID prescriptions in a veteran patient population with CHF by implementing an electronic health record (EHR) alert advising against NSAID prescriptions. Methods: This single-center quality improvement project was initiated at the Miami Veterans Affairs Medical Center. In patients with any diagnosis of heart failure, when a provider attempted to initiate or renew an NSAID prescription, an EHR alert was activated warning of the potential harms. Providers were required to acknowledge the alert prior to electronic signature. NSAIDs activating the alert included celecoxib, ibuprofen, diclofenac, and naproxen. The primary outcome of interest was the number of patients with CHF and active NSAID prescriptions, assessed 6 months before and after alert implementation. Analysis of the combined long-term secondary outcomes of hospitalization for acute decompensated heart failure and all-cause mortality is ongoing. Relative risk reductions with statistical significance determined by p<0.05 were calculated for both primary and secondary outcomes. Results: A total of 144 patients were included in this study. In the 6 months preceding alert implementation, NSAIDs were discontinued in 30.9% (17/55) of patients. At 6 months follow-up after EHR alert initiation, NSAIDs were discontinued or left to expire in 65.2% (58/89) of patients in which the EHR alert was activated. The relative risk of patients with CHF being prescribed NSAIDs was significantly reduced by 49.6% (relative risk=0.504; 95% confidence interval [0.361-0.704], p=0.0001). After intervention, death was reported in 3.2% of patients persisting on NSAID therapy, compared to 1.7% of patients that had NSAIDs discontinued (p=0.65). Conclusions: Implementation of an EHR alert advising of the harm of NSAIDs in patients with CHF in a veteran population has resulted in a statistically significant decrease in the number of active NSAID prescriptions. Further study with larger patient populations and extended follow-up will help determine whether these findings are sustainable and lead to a clinically significant reduction in mortality and hospitalizations.

scholarly journals Randomised controlled trial of gradual antipsychotic reduction and discontinuation in people with schizophrenia and related disorders: the RADAR trial (Research into Antipsychotic Discontinuation and Reduction)

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030912 ◽  
Author(s):  
Joanna Moncrieff ◽  
Glyn Lewis ◽  
Nick Freemantle ◽  
Sonia Johnson ◽  
Thomas R E Barnes ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Effects ◽  
Social Functioning ◽  
Antipsychotic Medication ◽  
Controlled Trial ◽  
Long Term Outcome ◽  
Increased Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

IntroductionAntipsychotic medication is effective in reducing acute symptoms of psychosis, but it has a range of potentially serious and debilitating adverse effects and is often disliked by patients. It is therefore essential it is only used when benefits outweigh harms. Although multiple trials conducted with people with schizophrenia indicate an increased risk of relapse in the short-term following abrupt antipsychotic discontinuation, there is little evidence about the long-term outcome of a gradual process of reduction and discontinuation on social functioning, relapse and other outcomes.Methods and analysisThis is a multicentre, randomised controlled trial involving people with schizophrenia and related disorders who have had more than one episode. Participants are randomised to have a clinically-supervised, gradual reduction of antipsychotic medication, leading to discontinuation when possible, or to continue with maintenance treatment. Blinded follow-up assessments are conducted at 6, 12 and 24 months and the primary outcome is social functioning, measured by the Social Functioning Scale at 24 months. A minimum of 134 evaluable participants provides 90% power to detect a five-point difference, and 206 to detect a four-point difference. Secondary outcomes include severe relapse (admission to hospital) and the study is also intended to detect a minimum 10% difference in severe relapse, which requires 402 participants, assuming a 15% loss to follow-up. Other secondary outcomes include all relapses, as identified by an independent and blinded endpoint committee, symptoms measured by the Positive and Negative Syndrome Scale, quality of life, adverse effects, self-rated recovery and neuropsychological measures. Enrolment started in 2016. The trial is scheduled to finish in June 2022.Ethics and disseminationEthical approval was initially obtained on 27 October 2016 (UK Research Ethics Committee reference 16/LO/1507). Results will be published in peer-reviewed journals and disseminated to the public.Trial registration numberISRCTN90298520. EudraCT: 2016-000709-36. Pre-results.

Eine Therapie mit Everolimus und reduziertem Ciclosporin kann das Krebsrisiko von Nierentransplantierten verringern* (Sponsor: Novartis Pharma GmbH, Nürnberg)

2017 ◽  
Vol 05 (01) ◽  
pp. 22-22
Keyword(s):  
New Zealand ◽  
De Novo

ZusammenfassungDie Verknüpfung der A2309-Studie mit dem Australia and New Zealand Dialysis and Transplant (ANZDATA) Register erlaubte ein Follow up von 7 Jahren. Die Autoren bezeichnen diese Analyse als die bisher überzeugendste Evidenz, dass eine Immunsuppression mit de novo Everolimus und reduziertem Ciclosporin langfristig mit einer geringeren Krebsinzidenz nach Nierentransplantation assoziiert ist als die Standardtherapie.

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