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Open AccessSelective digestive tract decontamination to prevent healthcare associated infections in critically ill children: the PICNIC multicentre randomised pilot clinical trial
Healthcare-associated infections (HCAIs) are a major cause of morbidity and mortality in critically ill children. Data from adult studies suggest Selective Decontamination of the Digestive tract (SDD) may redu...
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Article
Open AccessThe perception of risk in contracting and spreading COVID-19 amongst individuals, households and vulnerable groups in England: a longitudinal qualitative study
Social distancing restrictions to manage the COVID-19 pandemic were put in place from March 2020 in the United Kingdom (UK), with those classed as “highly clinically vulnerable” advised to shield entirely and ...
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Article
Open AccessComplex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action
Informed consent is considered a fundamental requirement for participation in trials, yet obtaining consent is challenging in a number of populations and settings. This may be due to participants having commun...
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Article
Open AccessAssociations between parent–child relationship, and children’s externalizing and internalizing symptoms, and lifestyle behaviors in China during the COVID-19 epidemic
To investigate associations between parent–child relationships, children’s externalizing and internalizing symptoms, and lifestyle responses to the COVID-19 epidemic, we conducted an online survey of a random,...
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Article
Open AccessCan they stomach it? Parent and practitioner acceptability of a trial comparing gastric residual volume measurement versus no gastric residual volume in UK NNU and PICUs: a feasibility study
Routine measurement of gastric residual volume (GRV) to guide feeding in neonatal and paediatric intensive care is widespread. However, this practice is not evidence based and may cause harm. As part of a feas...
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Article
Open AccessThe PLANES study: a protocol for a randomised controlled feasibility study of the placental growth factor (PlGF) blood test-informed care versus standard care alone for women with a small for gestational age fetus at or after 32 + 0 weeks’ gestation
Stillbirth remains a major concern across the globe and in some high-resource countries, such as the UK; efforts to reduce the rate have achieved only modest reductions. One third of stillborn babies are small...
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Article
Open AccessDiagnostic test accuracy of point-of-care procalcitonin to diagnose serious bacterial infections in children
The National Institute for Health and Care Excellence (NICE) have called for research into the role of biomarkers, and specifically procalcitonin (PCT), for the early diagnosis of serious bacterial infections ...
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Article
Open AccessEnhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study
EcLiPSE (Emergency treatment with Levetiracetam or Phenytoin in Status Epilepticus in children) is a randomised controlled trial (RCT) in the United Kingdom. Challenges to success include the need to immediate...
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Article
Open AccessPermissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial
Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in critically ill children. We performed a pilot RCT to determine w...
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Article
Open AccessPatient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences
Historically, patient and public involvement (PPI) in the design and conduct of surgical trials has been absent or minimal, but it is now routinely recommended and even required by some research funders. We ai...
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Article
Open AccessNon-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol
Bronchiolitis is an acute lower respiratory infection which predominantly affects young children. Treatment for bronchiolitis is limited to supportive therapy. Nasal oxygen therapy is part of routine care, and...
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Article
Open AccessThe “Petechiae in children” (PiC) study: evaluating potential clinical decision rules for the management of feverish children with non-blanching rashes, including the role of point of care testing for Procalcitonin & Neisseria meningitidis DNA – a study protocol
Children commonly present to Emergency Departments (ED) with a non-blanching rash in the context of a feverish illness. While most have a self-limiting viral illness, this combination of features potentially r...
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Article
Open AccessEmergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial
Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the famil...
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Article
Open AccessA patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – a work in progress
Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that...
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Article
Open AccessGood practice principles for sharing individual participant data from publicly funded clinical trials
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Open AccessDevelo** a patient and public involvement intervention to enhance recruitment and retention in surgical trials (PIRRIST): study protocol
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Open AccessDevelo** a toolkit for patient and public involvement in a clinical trials unit
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Open AccessWhat are parents’ priorities when being invited to enter their child into a clinical trial and how far do they voice their priorities?
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Article
Open AccessPractitioner views and experiences of deferred consent in paediatric and neonatal emergency care trials: the connect study
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Article
Open AccessHow experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials
In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in a...