Erratum to: Pediatric intensive care stress ulcer prevention (PIC-UP): a protocol for a pilot randomized trial.
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ABSTRACT:
SUBMITTER: Duffett M
PROVIDER: S-EPMC5561631 | biostudies-other | 2017
REPOSITORIES: biostudies-other
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Project description:BACKGROUND:Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT of stress ulcer prophylaxis with pantoprazole to prevent upper GI bleeding vs. placebo. METHODS:A multi-centre blinded pilot RCT of 120 children in six Canadian PICUs. Children expected to require mechanical ventilation for more than 48 h will be randomized to receive intravenous pantoprazole 1 mg/kg or identical placebo once daily until they no longer need mechanical ventilation. We have four feasibility outcomes and will consider the trial successful if we achieve:Effective screening: If >80% of eligible patients are approached for consent.Timely enrollment: if >80% of participants receive their first dose of the assigned study drug within 1 day of becoming eligible.Participant accrual: If the average monthly enrolment is two or more participants per centre per month.Protocol adherence: if >90% of doses are administered according to the protocol. DISCUSSION:There are many uncertainties about the risks and benefits of stress ulcer prophylaxis. In an era of widespread use-where clinicians prescribe prophylaxis to the more severely ill-a large, rigorous RCT is required. A trial to determine if a strategy of withholding stress ulcer prophylaxis is not inferior to a strategy of routine stress ulcer prophylaxis will be challenging. A carefully designed and implemented pilot trial is essential. TRIAL REGISTRATION:ClinicalTrials.gov:NCT02929563 (Registered October 3, 2016).
| S-EPMC5438532 | biostudies-literature
Project description:PIC (Paediatric Intensive Care) is a large paediatric-specific, single-centre, bilingual database comprising information relating to children admitted to critical care units at a large children's hospital in China. The database is deidentified and includes vital sign measurements, medications, laboratory measurements, fluid balance, diagnostic codes, length of hospital stays, survival data, and more. The data are publicly available after registration, which includes completion of a training course on research with human subjects and signing of a data use agreement mandating responsible handling of the data and adherence to the principle of collaborative research. Although the PIC can be considered an extension of the widely used MIMIC (Medical Information Mart for Intensive Care) database in the field of paediatric critical care, it has many unique characteristics and can support database-based academic and industrial applications such as machine learning algorithms, clinical decision support tools, quality improvement initiatives, and international data sharing.
| S-EPMC6957490 | biostudies-literature
Project description:BackgroundFever in children is a major problem in pediatric oncology. Usual management leads to immediate antibiotic and antipyretic therapy, although there is consensus that antipyretic therapy should not be utilized with the sole aim of reducing body temperature. Increased body temperature during fever appears to be an effective modifier in terms of viral replication and enhanced host defense mechanisms against pathogens. Therefore, it might be beneficial to support febrile patients by applying gentle heat during the onset of fever to help the body to reach its new thermoregulatory set point.MethodsA randomized pilot study over 6 months will be conducted in a pediatric oncology department in an academic hospital in Germany. This study is a preparation for a multicenter clinical trial with two parallel groups concerning the efficacy of heat application vs. treatment as usual. One of the inclusion criteria is body temperatures ≥ 38.0 °C in n = 24 cases of patients receiving chemotherapy aged 18 months to 17 years. The first intervention consists of gentle heat application with hot water bottles at any sign of illness and onset of fever. The aim is to achieve a warm periphery equilibrated to trunk temperature of less than 0.5 °C. The second intervention is the avoidance of antipyretics. The control group receives the standard antipyretic treatment from the participating hospital. The purposes of this pilot study are proof of principle of intervention, evaluation of safety, feasibility, definition of endpoints, and to receive basic data for sample size calculation and needed resources.DiscussionThe main goal is to improve the care of children with cancer by providing the best possible support for febrile episodes. If fever support by heat reduces discomfort, administration of antipyretics and maybe even antibiotics, this would be an advancement in oncological fever management. This pilot study is intended to provide a basis for a main, multicenter, randomized trial and demonstrate the practicability of heat application in febrile patients in pediatric oncology.Trial registrationGerman Clinical Trials Register (DRKS), DRKS00028273 . Registered on 14 April 2022.
| S-EPMC9380316 | biostudies-literature
Project description:IntroductionPressure ulcers (PUs) are associated with substantial health burden. Patients in intensive care units (ICUs) are at high risk for developing PU. In the absence of large randomised controlled trials (RCTs) that compare commonly known interventions for preventing PU in ICUs, uncertainty remains around the best practice strategy for PU management in adult ICUs. This study, therefore, aims to identify the most effective interventions and combinations of interventions that prevent PU in adult ICU using systematic review and network meta-analysis (NMA).Methods and analysisWe will search for all published and unpublished RCTs evaluating interventions to prevent PU compared with other PU prevention measures or with usual care in adult ICU. The primary outcomes are the incidence of PUs and PU severity in critically ill patients in ICU. The secondary outcomes include number of PUs per patient and intervention-related harms caused by the prevention intervention or intervention-related harms. All data extraction will be performed by at least two independent reviewers on the basis of a priori developed extraction form. We will evaluate the risk of bias of the included RCTs in accordance with the Cochrane Collaboration's risk of bias tool, and assess the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation. A standard pairwise meta-analysis and a Bayesian NMA will be conducted to compare the efficacy of different PU prevention interventions. A surface under the cumulative ranking curve will be used to rank the probabilities of each prevention intervention for various outcomes.Ethics and disseminationThis study will not require the ethics approval as it is a review based on published studies. The findings of this study will be submitted to a peer-reviewed journal for publication. We anticipate that the results of the study will provide the evidence to inform clinicians and guideline developers on determining the best interventions for the prevention of PU in ICU patients.Prospero registration numberCRD42018085562.
| S-EPMC6500189 | biostudies-literature
Project description:BackgroundIntermittent fasting is a time-restricted feeding strategy with proven health benefits, which is based on multiple metabolic and endocrine changes, in several patient populations and healthy participants. In the pediatric intensive care unit (PICU), artificial feeding is usually administered 24 hours a day, although solid evidence supporting this practice is lacking. This discards the potential benefits of fasting in this population. We hypothesize that intermittent nutrition with a focus on an overnight feeding interruption (intermittent fasting), as compared with 24-hour continuous nutrition, is a feasible and safe strategy, with potential benefits, for critically ill children.ObjectiveThe aim of the Continuous versus Intermittent Nutrition in Pediatric Intensive Care randomized controlled trial (RCT) is to investigate a strategy of intermittent nutrition with a focus on an overnight feeding interruption period versus 24-hour nutrition during the first 14 days in the PICU.MethodsThe Continuous versus Intermittent Nutrition in Pediatric Intensive Care study is an investigator-initiated RCT in a tertiary referral PICU. Critically ill children (term newborn to 18 years), expected to stay in the PICU for ≥48 hours, and dependent on artificial nutrition, are eligible for inclusion. This study will randomize critically ill children (n=140) to a continuous versus intermittent nutrition strategy. In both groups, similar daily caloric targets will be prescribed. In the continuous group (control), nutrition will be administered 24 hours a day, with a maximum interruption period of 2 hours. In the intermittent group (intervention), nutrition will be interrupted during an age-dependent overnight fasting period. The study intervention will last until admission day 14, initiation of oral intake, or discharge from the PICU, whichever comes first. The primary outcome is the difference in ketosis between the groups under the condition of noninferiority regarding caloric intake. Secondary outcomes are feeding intolerance; the proportion of severe and resistant hypoglycemic events and severe gastrointestinal complications; and additional observed effects on nutritional intake, circadian rhythm, and clinically relevant outcome measures of the intermittent feeding strategy compared with continuous nutrition.ResultsThe study was approved by the Dutch national ethical review board in February 2020. The first patient was enrolled on May 19, 2020. By May 2022, a total of 132 patients had been included in the study. Recruitment of the last patient is expected in Q3 2022.ConclusionsAlthough intermittent fasting has been proven to have many health benefits in both animal and human studies, the feasibility and safety of this strategy in a PICU setting must be investigated. This RCT will help physicians gain more insight into the feasibility, safety, and potential clinical effects of intermittent feeding with overnight fasting in critically ill children.Trial registrationNetherlands Trial Register NL7877; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7877.International registered report identifier (irrid)DERR1-10.2196/36229.
| S-EPMC9264130 | biostudies-literature
Project description:ObjectiveIndividuals with advanced knee osteoarthritis (OA) and a large body size [a body mass index (BMI) ≥35 kg/m2] have a higher risk of complications with total knee arthroplasty (TKA), and hence may be ineligible for surgery unless they reduce their BMI. However, pre-TKA weight-loss has not been shown to reduce surgical infection risk and may inadvertently increase risk for muscle loss and development of sarcopenic obesity (low muscle and low strength with higher fat mass). This suggests that a knee OA management approach that doesn't focus on weight change (weight-neutral) may be beneficial. This study examines if a weight-neutral behavioural intervention is feasible and acceptable to participants, and improves muscle mass and physical function in comparison to usual care.DesignThis pilot randomized clinical trial compares a 12-week multimodal intervention [including targeted nutrition, progressive resistance exercise, and arthritis self-management support] to usual care. Co-primary outcomes are feasibility and acceptability, with secondary outcomes of change in lean soft tissue and physical function within and between groups at 3-months and 9-months from baseline. Change in waist circumference, fat mass, blood biomarkers, energy metabolism, OA-related pain and function, health-related quality of life, self-efficacy for arthritis management, and interest in pursuing a TKA within and between groups will be explored.ConclusionThis study will inform future development of more personalized knee OA treatment approaches for adults with larger bodies. Further, this will contribute to effective alternative treatment pathways that reduce inequities in access to OA care for this understudied patient population.
| S-EPMC9718278 | biostudies-literature
Project description:Medical settings provide opportunities for secondary prevention of traumatic stress and other sequelae of pediatric injury. This pilot randomized trial evaluated the delivery and effectiveness of a targeted preventive intervention based on best practice recommendations and integrated within acute medical care. Hospitalized injured children were screened for risk of developing posttraumatic stress disorder (PTSD). Those at risk (N = 85) were randomized to the intervention (n = 46) or usual care (n = 39). The preventive intervention did not reduce PTSD or depression severity or increase health-related quality of life, compared to usual care. Both groups improved over time, but 6 months postinjury approximately 10% of each group still met criteria for PTSD, suggesting room for improvement in comprehensive pediatric injury care.
| S-EPMC8935905 | biostudies-literature
Project description:BackgroundA pediatric cancer diagnosis and its treatment can have a detrimental effect on the mental health of children and their families. Screening to identify psychosocial risk in families has been recognized as a standard of care in pediatric oncology, but there has been limited clinical application of this standard thus far. A significant impediment to the implementation of psychosocial screening is the dearth of information on how to translate psychosocial screening to clinical practice, and specifically, how to follow-up from screening results. This manuscript aims to describe a protocol of a new intervention examining the feasibility and acceptability of mapping via a Psychosocial Navigator (PSN) psychosocial screening results to specific recommendations of resources for families based on measured risk for psychosocial distress and mental health symptoms.MethodsThe pilot randomized control trial (RCT) consists of dyads of youth (10-17 years) newly diagnosed with cancer and their primary caregiver. This RCT includes two arms (intervention and control group), with each group completing measurements near diagnosis and 1 year later. After the initial assessment, dyads in the intervention group receive monthly screening results and recommendations from the study PSN that are tailored to these results. The patient's primary healthcare team (nurse, social worker, oncologist) also receive the risk, distress, and mental health results as well as the recommendations from the PSN.DiscussionThis study addresses a significant barrier to the implementation of psychosocial screening in pediatric oncology: specifically, the limited knowledge of how to follow-up from screening results. Findings from this pilot will inform a future definitive RCT to test the effectiveness of the intervention on patient and family mental health outcomes. This project has implications for enhancing clinical care in pediatric oncology, as well as other pediatric populations.Strengths and limitations of this studyThis is the first study of screening and follow-up using a psychosocial navigator. This study involves both patient and caregiver report. The small sample size necessitates a future larger study to investigate the effects of intervention.Trial registrationNCT04132856 , Registered 10 October 2019-retrospectively registered.
| S-EPMC8285781 | biostudies-literature
Project description:IntroductionIncreasing numbers of patients are surviving critical illness, leading to growing concern about the potential impact of the long-term consequences of intensive care on patients, families and society as a whole. These long-term effects are together known as postintensive care syndrome and their presence can be evaluated at intensive care unit (ICU) follow-up consultations. However, the services provided by these consultations vary across hospitals and units, in part because there is no validated standard model to evaluate patients and their quality of life after ICU discharge. We describe a protocol for a scoping review focusing on models of ICU follow-up and the impact of such strategies on improving patient quality of life.Methods and analysisIn this scoping review, we will search the literature systematically using electronic databases (MEDLINE - from database inception to June 15th 2020) and a grey literature search. We will involve stakeholders as recommended by the Joanna Briggs Institute approach developed by Peters et al. The research will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines.Ethics and disseminationThis study does not require ethics approval, because data will be obtained through a review of published primary studies. The results of our evaluation will be published in a peer-reviewed journal and will also be disseminated through presentations at national and international conferences.
| S-EPMC7643502 | biostudies-literature
Project description:BackgroundThe 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable.AimTo present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context.MethodsGuided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle.ResultsA PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care.ConclusionUsing KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.
| S-EPMC4939576 | biostudies-literature