Protein supplementation versus standard feeds in underweight critically ill children: a pilot dual-centre randomised controlled trial protocol

IntroductionProtein–energy malnutrition, increased catabolism and inadequate nutritional support leads to loss of lean body mass with muscle wasting and delayed recovery in critical illness. However, there remains clinical equipoise regarding the risks and benefits of protein supplementation. This pilot trial will determine the feasibility of performing a larger multicentre trial to determine if a strategy of protein supplementation in critically ill children with body mass index (BMI) z-score ≤−2 is superior to standard enteral nutrition in reducing the length of stay in the paediatric intensive care unit (PICU).Methods and analysisThis is a randomised controlled trial of 70 children in two PICUs in Singapore. Children with BMI z-score ≤−2 on PICU admission, who are expected to require invasive mechanical ventilation for more than 48 hours, will be randomised (1:1 allocation) to protein supplementation of ≥1.5 g/kg/day in addition to standard nutrition, or standard nutrition alone for 7 days after enrolment or until PICU discharge, whichever is earlier. Feasibility outcomes for the trial include effective screening, satisfactory enrolment rate, timely protocol implementation (within first 72 hours) and protocol adherence. Secondary outcomes include mortality, PICU length of stay, muscle mass, anthropometric measurements and functional outcomes.Ethics and disseminationThe trial protocol was approved by the institutional review board of both participating centres (Singhealth Centralised Institutional Review Board and National Healthcare Group Domain Specific Review Board) under the reference number 2020/2742. Findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.Trial registration numberNCT04565613.

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‘Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing’ (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention

BMJ Open ◽

10.1136/bmjopen-2020-039299 ◽

2020 ◽

Vol 10 (8) ◽

pp. e039299

Author(s):

Douglas J Opel ◽

Jeffrey D Robinson ◽

Heather Spielvogle ◽

Christine Spina ◽

Kathleen Garrett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Motivational Interviewing ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Communication Strategy ◽

Institutional Review Board ◽

Cluster Randomised ◽

Institutional Review ◽

Randomised Controlled ◽

Immunisation Status

IntroductionA key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents’ minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.Methods and analysisWe describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.Ethics and disseminationThis study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration numberNCT03885232.

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Pilot randomised controlled trial of a patient navigation intervention to enhance engagement in the PrEP continuum among young Latino MSM: a protocol paper

BMJ Open ◽

10.1136/bmjopen-2020-040955 ◽

2021 ◽

Vol 11 (5) ◽

pp. e040955

Author(s):

Aaron J Blashill ◽

Janna R Gordon ◽

Sarah A Rojas ◽

Christian B Ramers ◽

Chii-Dean Lin ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Patient Navigation ◽

Controlled Trial ◽

Institutional Review Board ◽

State University ◽

Pilot Randomised Controlled Trial ◽

Latino Msm ◽

Institutional Review ◽

San Diego State University ◽

Randomised Controlled

IntroductionMen who have sex with men (MSM) are one of the most at-risk group for contracting HIV in the USA. However, the HIV epidemic impacts some groups of MSM disproportionately. Latino MSM comprise 25.1% of new HIV infections among MSM between the ages of 13 and 29 years. The daily medication tenofovir/emtricitabine was approved by the Food and Drug Administration for pre-exposure prophylaxis (PrEP) in 2012 and has demonstrated strong efficacy in reducing HIV acquisition.Methods and analysisThrough extensive formative research, this study uses a pilot randomised controlled trial design and will examine the feasibility and acceptability of a patient navigation intervention designed to address multiple barriers to improve engagement in the PrEP continuum among 60 Latino MSM between the ages of 18 and 29 years. The patient navigation intervention will be compared with usual care plus written information to evaluate the feasibility and acceptability of the intervention and study methods and the intervention’s potential in improving PrEP continuum behaviours. The results will be reviewed for preparation for a future full-scale efficacy trial.Ethics and disseminationThis study was approved by the institutional review board at San Diego State University and is registered at ClinicalTrials.gov. The intervention development process, plan and the results of this study will be shared through peer-reviewed journal publications, conference presentations and healthcare system and community presentations.Registration detailsRegistered under the National Institutes of Health’s ClinicalTrials.gov (NCT04048382) on 7 August 2019 and approved by the San Diego State University (HS-2017–0187) institutional review board. This study began on 5 August 2019 and is estimated to continue through 31 March 2021. The clinical trial is in the pre-results stage.

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