scholarly journals Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED): Study Protocol and Analysis Plan

2021 ◽  
Vol 9 ◽  
Author(s):  
Amanda Harley ◽  
Shane George ◽  
Megan King ◽  
Natalie Phillips ◽  
Gerben Keijzers ◽  
...  
Keyword(s):  
Emergency Department ◽  
Septic Shock ◽  
Clinical Trials ◽  
New Zealand ◽  
Pilot Study ◽  
Fluid Resuscitation ◽  
Study Cohort ◽  
Fluid Bolus ◽  
Randomised Controlled ◽  
Clinical Trials Registry

Introduction: Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40–60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. We hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, we describe the protocol of the Early Resuscitation in Paediatric Sepsis Using Inotropes – A Randomised Controlled Pilot Study in the Emergency Department (RESPOND ED).Methods and analysis: The RESPOND ED study is an open label randomised controlled, two arm, multicentre pilot study conducted at four specialised paediatric Emergency Departments. Forty children aged between 28 days and 18 years treated for presumed septic shock will be randomized in a 1:1 ratio to early inotropes vs. standard fluid resuscitation. Early inotrope treatment is defined as the commencement of a continuous intravenous adrenaline infusion after 20 mL/kg fluid bolus resuscitation. Standard fluid resuscitation is defined as delivery of 40 to 60 mL/kg fluid bolus resuscitation prior to commencement of inotropes. In addition to feasibility outcomes, survival free of organ dysfunction censored at 28 days will be assessed as the main clinical outcome. The study cohort will be followed up at 28 days, and at 6 months post enrolment to assess quality of life and functional status. Biobanking nested in the study cohort will be performed to enable ancillary biomarker studies.Ethics and dissemination: The trial has ethical clearance (Children's Health Queensland, Brisbane, HREC/18/QCHQ/49168) and is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12619000828123). Enrolment commenced on July 21st, 2019. The primary manuscript will be submitted for publication in a peer-reviewed journal.Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12619000828123.

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

2018 ◽  
Vol 28 (4) ◽  
pp. 955-962 ◽  
Author(s):  
Rebecca Mercieca-Bebber ◽  
◽  
Douglas Williams ◽  
Margaret-Ann Tait ◽  
Claudia Rutherford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Clinical Trials Registry

scholarly journals The Influence of Gender and Age on the Outcomes of and Adherence to a Digital Interdisciplinary Mental Health Promotion Intervention in an Australasian Nonclinical Setting: Cohort Study (Preprint)

2021 ◽  
Author(s):  
Geraldine Przybylko ◽  
Darren Morton ◽  
Jason Morton ◽  
Melanie Renfrew
Keyword(s):  
Mental Health ◽  
Health Promotion ◽  
Clinical Trials ◽  
New Zealand ◽  
Well Being ◽  
Mental Health Promotion ◽  
Satisfaction With Life Scale ◽  
Gender And Age ◽  
Clinical Trials Registry ◽  
Health And Well Being

BACKGROUND The global prevalence of mental health disorders is at a crisis point, particularly in the wake of COVID-19, prompting calls for the development of digital interdisciplinary mental health promotion interventions (MHPIs) for nonclinical cohorts. However, the influence of gender and age on the outcomes of and adherence to MHPIs is not well understood. OBJECTIVE The aim of this study was to determine the influence of gender and age on the outcomes of and adherence to a 10-week digital interdisciplinary MHPI that integrates strategies from positive psychology and lifestyle medicine and utilizes persuasive systems design (PSD) principles in a nonclinical setting. METHODS This study involved 488 participants who completed the digital interdisciplinary MHPI. Participants completed a pre and postintervention questionnaire that used: (1) the “mental health” and “vitality” subscales from the Short Form 36 (SF-36) Health Survey; (2) the Depression, Anxiety and Stress Scale (DASS-21); and (3) Satisfaction With Life Scale (SWL). Adherence to the digital interdisciplinary MHPI was measured by the number of educational videos the participants viewed and the extent to which they engaged in experiential challenge activities offered as part of the program. RESULTS On average, the participants (N=488; mean age 47.1 years, SD 14.1; 77.5% women) demonstrated statistically significant improvements in all mental health and well-being outcome measures, and a significant gender and age interaction was observed. Women tended to experience greater improvements than men in the mental health and well-being measures, and older men experienced greater improvements than younger men in the mental health and vitality subscales. Multiple analysis of variance results of the adherence measures indicated a significant difference for age but not gender. No statistically significant interaction between gender and age was observed for adherence measures. CONCLUSIONS Digital interdisciplinary MHPIs that utilize PSD principles can improve the mental health and well-being of nonclinical cohorts, regardless of gender or age. Hence, there may be a benefit in utilizing PSD principles to develop universal MHPIs such as that employed in this study, which can be used across gender and age groups. Future research should examine which PSD principles optimize universal digital interdisciplinary MHPIs. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12619000993190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377889 and Australian New Zealand Clinical Trials Registry ACTRN12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx

scholarly journals Soil-transmitted helminth infections and nutritional indices among Filipino schoolchildren

2021 ◽  
Vol 15 (12) ◽  
pp. e0010008
Author(s):  
Mary Lorraine S. Mationg ◽  
Gail M. Williams ◽  
Veronica L. Tallo ◽  
Remigio M. Olveda ◽  
Eindra Aung ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trials ◽  
New Zealand ◽  
Health Education ◽  
Significant Risk ◽  
The Philippines ◽  
Trial Registration ◽  
Nutritional Indices ◽  
Attitudes And Practices ◽  
Clinical Trials Registry

Background Soil-transmitted helminth (STH) infections are still prevalent among schoolchildren in the Philippines. We evaluated the risk factors associated with STH and the relationship between STH and nutritional indices among schoolchildren aged 9–10 years in Laguna province, the Philippines. Methods We used the baseline data from 40 schools enrolled in a randomised controlled trial of the Magic Glasses Philippines health education package. Data on demographic and socio-economic variables, and STH related knowledge, attitudes and practices, were obtained through a questionnaire. Stool samples were collected and assessed for STH egg presence using the Kato-Katz technique. Haemoglobin levels and height and weight of study participants were also determined. The generalized estimating equations approach was used to construct logistic regression models to assess STH-associated risk factors, and the association between any STH infection and anaemia, child stunting, wasting and being underweight. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000508471). Findings Among 1,689 schoolchildren, the prevalence of any STH was 23%. The prevalence of anaemia, stunting, being underweight and wasting was 13%, 20.2%, 19% and 9.5%, respectively. Age, socio-economic status, rural/urban classification of schools and knowledge of STH were significant risk factors for acquiring a STH infection. Moreover, infections with any STH were significantly associated with stunting (P = <0.001) and being underweight (P = <0.003), but not wasting (P = 0.375) or anaemia (P = 0.462) after controlling for confounding covariates. Conclusion The study findings emphasise the need for sustainable deworming in tandem with other measures such as the provision of health education, improvements in sanitation and hygiene, and nutritional programs in order to control STH infections and improve morbidity outcomes in schoolchildren. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12616000508471).

scholarly journals The Influence of Gender and Age on the Outcomes of and Adherence to a Digital Interdisciplinary Mental Health Promotion Intervention in an Australasian Nonclinical Setting: Cohort Study

10.2196/29866 ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. e29866
Author(s):  
Geraldine Przybylko ◽  
Darren Morton ◽  
Jason Morton ◽  
Melanie Renfrew
Keyword(s):  
Mental Health ◽  
Health Promotion ◽  
Clinical Trials ◽  
New Zealand ◽  
Well Being ◽  
Mental Health Promotion ◽  
Trial Registration ◽  
Gender And Age ◽  
Clinical Trials Registry ◽  
Health And Well Being

Background The global prevalence of mental health disorders is at a crisis point, particularly in the wake of COVID-19, prompting calls for the development of digital interdisciplinary mental health promotion interventions (MHPIs) for nonclinical cohorts. However, the influence of gender and age on the outcomes of and adherence to MHPIs is not well understood. Objective The aim of this study was to determine the influence of gender and age on the outcomes of and adherence to a 10-week digital interdisciplinary MHPI that integrates strategies from positive psychology and lifestyle medicine and utilizes persuasive systems design (PSD) principles in a nonclinical setting. Methods This study involved 488 participants who completed the digital interdisciplinary MHPI. Participants completed a pre and postintervention questionnaire that used: (1) the “mental health” and “vitality” subscales from the Short Form 36 (SF-36) Health Survey; (2) the Depression, Anxiety and Stress Scale (DASS-21); and (3) Satisfaction With Life Scale (SWL). Adherence to the digital interdisciplinary MHPI was measured by the number of educational videos the participants viewed and the extent to which they engaged in experiential challenge activities offered as part of the program. Results On average, the participants (N=488; mean age 47.1 years, SD 14.1; 77.5% women) demonstrated statistically significant improvements in all mental health and well-being outcome measures, and a significant gender and age interaction was observed. Women tended to experience greater improvements than men in the mental health and well-being measures, and older men experienced greater improvements than younger men in the mental health and vitality subscales. Multiple analysis of variance results of the adherence measures indicated a significant difference for age but not gender. No statistically significant interaction between gender and age was observed for adherence measures. Conclusions Digital interdisciplinary MHPIs that utilize PSD principles can improve the mental health and well-being of nonclinical cohorts, regardless of gender or age. Hence, there may be a benefit in utilizing PSD principles to develop universal MHPIs such as that employed in this study, which can be used across gender and age groups. Future research should examine which PSD principles optimize universal digital interdisciplinary MHPIs. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12619000993190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377889 and Australian New Zealand Clinical Trials Registry ACTRN12619001009101; http://www.anzctr.org.au/ACTRN12619001009101.aspx

scholarly journals Assessing Sunscreen Protection Using UV Photography: Descriptive Study (Preprint)

2020 ◽  
Author(s):  
Caitlin Horsham ◽  
Helen Ford ◽  
Jeremy Herbert ◽  
Alexander Wall ◽  
Sebastian Walpole ◽  
...  
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Phase 1 ◽  
Sun Protection ◽  
Trial Registration ◽  
Phase 2 ◽  
Phase 3 ◽  
The Public ◽  
Uv Photography ◽  
Clinical Trials Registry

BACKGROUND Photography using a UV transmitting filter allows UV light to pass and can be used to illuminate UV blocking lotions such as sunscreens. OBJECTIVE The aim of this study is to compare currently available UV photography cameras and assess whether these devices can be used as visualization tools for adequate coverage of sun protection lotions. METHODS This study was conducted in 3 parts: in phase 1, 3 different UV cameras were tested; in phase 2, we explored whether UV photography could work on a range of sun protection products; and in phase 3, a UV webcam was developed and was field-tested in a beach setting. In phase 1, volunteers were recruited, and researchers applied 3 sun protection products (ranging from sun protection factor [SPF] 15 to 50+) to the participants’ faces and arms. UV photography was performed using 3 UV cameras, and the subsequent images were compared. In phase 2, volunteers were recruited and asked to apply their own SPF products to their faces in their usual manner. UV photographs were collected in the morning and afternoon to assess whether the coverage remained over time. Qualitative interviews were conducted to assess the participants’ level of satisfaction with the UV image. In phase 3, a small portable UV webcam was designed using a plug-and-play approach to enable the viewing of UV images on a larger screen. The developed webcam was deployed at a public beach setting for use by the public for 7 days. RESULTS The 3 UV camera systems tested during phase 1 identified the application of a range of sun protection lotions of SPF 15 to 50+. The sensitivity of the UV camera devices was shown to be adequate, with SPF-containing products applied at concentrations of 2 and 1 mg/cm<sup>2</sup> clearly visible and SPF-containing products applied at a concentration of 0.4 mg/cm<sup>2</sup> having lower levels of coverage. Participants in phase 2 reported high satisfaction with the UV photography images, with 83% (29/35) of participants likely to use UV photography in the future. During phase 2, it was noted that many participants used tinted SPF-containing cosmetics, and several tinted products were further tested. However, it was observed that UV photography could not identify the areas missed for all tinted products. During phase 3, the electrical components of the UV webcam remained operational, and the camera was used 233 times by the public during field-testing. CONCLUSIONS In this study, we found that UV photography could identify the areas missed by sun protection lotions with chemical filters, and participants were engaged with personalized feedback. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000975190; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377089 ; Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12619000145101; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376672.

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

2018 ◽  
Vol 27 (10) ◽  
pp. 2581-2591 ◽  
Author(s):  
Rebecca Mercieca-Bebber ◽  
◽  
Douglas Williams ◽  
Margaret-Ann Tait ◽  
Jessica Roydhouse ◽  
...  
Keyword(s):  
Clinical Trials ◽  
New Zealand ◽  
Patient Reported Outcomes ◽  
Patient Reported ◽  
Clinical Trials Registry

scholarly journals Protocol for a pilot randomised controlled trial of metformin in pre-diabetes after kidney transplantation: the Transplantation and Diabetes (Transdiab) study

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016813 ◽  
Author(s):  
Basil Alnasrallah ◽  
Helen Pilmore ◽  
Paul Manley
Keyword(s):  
Clinical Trials ◽  
Kidney Transplantation ◽  
Renal Transplantation ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Significant Morbidity ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionPost-transplant diabetes mellitus (PTDM) is a common complication of kidney transplantation and is associated with significant morbidity and mortality. In the general population, metformin has been used for diabetes prevention in high-risk individuals. Improving insulin sensitivity is one of many proven favourable effects of metformin. Despite the high incidence of PTDM in kidney transplant recipients, there is a lack of evidence for the role of metformin in the prevention of diabetes in this setting.Methods and analysisTransplantation andDiabetes (Transdiab)is a single-centre, unblinded, pilot randomised controlled trial assessing the feasibility, tolerability and efficacy of metformin after renal transplantation in patients with impaired glucose tolerance (IGT). Participants will undergo an oral glucose tolerance test in the 4–12 weeks post-transplantation; those with IGT will be randomised to standard care or standard care and metformin 500 mg twice daily, and followed up for 12 months. The primary outcomes of the study will be the feasibility of recruitment, the tolerability of metformin assessed using the Gastrointestinal Symptom Rating Scale at 3 and 12 months, and the efficacy of metformin assessed by morning glucose and glycated haemoglobin at 3, 6, 9 and 12 months.Ethics and disseminationDespite the significant morbidity and mortality of PTDM, there are currently no randomised clinical trials assessing pharmacological interventions for its prevention after kidney transplantation. The Transdiab trial will thus provide important data on the feasibility, safety, tolerability and efficacy of metformin after renal transplantation in patients with IGT; this will facilitate undertaking larger multicentre trials of interventions to reduce the incidence or severity of diabetes after kidney transplantation. This study has been approved by the Northern B Health and Disability Ethics Committee of the Ministry of Health in New Zealand. On study completion, results are expected to be published in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry Number: ACTRN12614001171606.

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