ResearchPad - paediatrics https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease]]> https://www.researchpad.co/article/elastic_article_12546 Low bone mineral density (BMD) is a frequent issue in children and adolescents with inflammatory bowel disease (IBD). Several studies in healthy populations have reported a positive impact of physical activity (PA) on bone health. Recently, an observational study in paediatric patients with IBD showed a significant positive relationship between daily PA and BMD. However, intervention studies investigating a causal relationship between PA and BMD are warranted to confirm these results. The aim of this randomised controlled trial will be to investigate the effect of a PA programme on BMD in paediatric patients with IBD.Methods and analysisThis trial is a multicentre (four centres), randomised, controlled, blinded end-point study. Eighty children with IBD will be randomly assigned in a 1:1 ratio to receive a programme with adapted physical exercises (intervention group) or usual PA (control group) during a 9-month period. The primary outcome is the change from baseline at 9 months (the end of the study) in whole-body BMD assessed by dual-energy X-ray absorptiometry. Secondary efficacy outcomes include the changes from baseline at 9 months in: BMD assessed in the lumbar spine and trochanter; daily PA (time spent in moderate-to-vigorous PA); body composition (fat mass and fat-free mass); fatigue resistance; quality of life and activity of IBD.Ethics and disseminationThe study was approved by the Research Ethics Committee in France (Comité de Protection des Personnes, Sud-Ouest and Outre-Mer III, Bordeaux, France, No 2018/27). All procedures will be performed according to the ethical standards of the Helsinki Declaration of 1975, as revised in 2008, and the European Union’s Guidelines for Good Clinical Practice. Written informed consent will be obtained from the parents or legal guardian and from the children. Research findings will be disseminated in peer-reviewed journals and scientific meetings.Trial registration numberNCT03774329. ]]> <![CDATA[Comparison of common interventions for the treatment of infantile colic: a systematic review of reviews and guidelines]]> https://www.researchpad.co/article/elastic_article_9135 To conduct a systematic review of systematic reviews and national guidelines to assess the effectiveness of four treatment approaches (manual therapy, probiotics, proton pump inhibitors and simethicone) on colic symptoms including infant crying time, sleep distress and adverse events.MethodsWe searched PubMed, Embase, Cochrane and Mantis for studies published between 2009 and 2019. Inclusion criteria were systematic reviews and guidelines that used evidence and expert panel opinion. Three reviewers independently selected articles by title, abstract and full paper review. Data were extracted by one reviewer and checked by a second. Selected studies were assessed for quality using modified standardised checklists by two authors. Meta-analysed data for our outcomes of interest were extracted and narrative conclusions were assessed.ResultsThirty-two studies were selected. High-level evidence showed that probiotics were most effective for reducing crying time in breastfed infants (range −25 min to −65 min over 24 hours). Manual therapies had moderate to low-quality evidence showing reduced crying time (range −33 min to −76 min per 24 hours). Simethicone had moderate to low evidence showing no benefit or negative effect. One meta-analysis did not support the use of proton pump inhibitors for reducing crying time and fussing. Three national guidelines unanimously recommended the use of education, parental reassurance, advice and guidance and clinical evaluation of mother and baby. Consensus on other advice and treatments did not exist.ConclusionsThe strongest evidence for the treatment of colic was probiotics for breastfed infants, followed by weaker but favourable evidence for manual therapy indicated by crying time. Both forms of treatment carried a low risk of serious adverse events. The guidance reviewed did not reflect these findings.PROSPERO registration numberCRD42019139074. ]]> <![CDATA[Paediatricians’ attitudes and beliefs towards transgender people: a cross-sectional survey in Israel]]> https://www.researchpad.co/article/N4f9fb5c3-72cb-4c8b-901a-49c4c0bd73ac The number of transgender and gender non-conforming children is on the rise. For these children, the timing of medical intervention is crucial, yet transgender children report poorer overall physical and mental health outcomes compared with their cisgender peers. We aim to describe how paediatricians perceive transgender people.SettingThe ‘Transgender Attitudes and Beliefs Scale’, which consists of 29 items in three domains—human value, interpersonal comfort and sex/gender beliefs—was administered to 391 senior and resident paediatricians in Israel. The responses on a 7-point Likert scale were collapsed into two categories: a mean score of ≥6 for each domain was a ‘Favourable’ perception and <6 ‘Unfavourable’.ResultsOf 355 respondents (91% response rate), 221 (62%) were females, 132 (37%) were males and 2 identified as ‘other’; 290 (82%) were born in ‘trans-respect countries’, 274 (77%) identified as secular, 223 (63%) were senior physicians and 132 (27%) were residents. Overall, 90% of the cohort scored favourably on the ‘Human value’ domain, 68% on ‘Interpersonal comfort’ and 40% on ‘Sex/gender beliefs’. In the ‘Interpersonal comfort’ domain, being a man, birthplace in a transphobic country, identification as religious and being a senior physician were all associated with increased ORs for an unfavourable score: 2.1 (95% CI 1.3 to 3.4), 3.4 (95% CI 1.9 to 6.3), 2.4 (95% CI 1.4 to 4.2) and 1.8 (95% CI 1.1 to 3.0), respectively. In the ‘Sex/gender beliefs’ domain, being a man and identifying as religious had significantly increased ORs for unfavourable scores: 2.2 (95% CI 1.3 to 3.5) and 10.6 (95% CI 4.7 to 24.1), respectively.ConclusionsNegative attitudes towards transgender people are still widespread among paediatricians. Interventions are warranted to positively impact these attitudes. ]]> <![CDATA[Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol]]> https://www.researchpad.co/article/N7b82e4e3-a030-426e-95e6-8c9bcf346236 Continuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings.Methods and analysisThe purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan University—Nairobi and (2) a clinical feasibility evaluation phase at Pumwani Maternity Hospital in Nairobi, Kenya. Both quantitative and qualitative data are collected and analysed. Agreement between the investigational and reference devices is determined using a priori-defined accuracy thresholds.Ethics and disseminationThis trial was approved by the Aga Khan University Nairobi Research Ethics Committee and the Western Institutional Review Board. We plan to disseminate research results in peer-reviewed journals and international conferences.Trial registration numberNCT03920761. ]]> <![CDATA[Evaluating the Alimentary and Respiratory Tracts in Health and disease (EARTH) research programme: a protocol for prospective, longitudinal, controlled, observational studies in children with chronic disease at an Australian tertiary paediatric hospital]]> https://www.researchpad.co/article/N77e5db44-1050-450f-acb4-1d939d90a9a6 Chronic gastrointestinal and respiratory conditions of childhood can have long-lasting physical, psychosocial and economic effects on children and their families. Alterations in diet and intestinal and respiratory microbiomes may have important implications for physical and psychosocial health. Diet influences the intestinal microbiome and should be considered when exploring disease-specific alterations. The concepts of gut-brain and gut-lung axes provide novel perspectives for examining chronic childhood disease(s). We established the ‘Evaluating the Alimentary and Respiratory Tracts in Health and disease’ (EARTH) research programme to provide a structured, holistic evaluation of children with chronic gastrointestinal and/or respiratory conditions.Methods and analysisThe EARTH programme provides a framework for a series of prospective, longitudinal, controlled, observational studies (comprised of individual substudies), conducted at an Australian tertiary paediatric hospital (the methodology is applicable to other settings). Children with a chronic gastrointestinal and/or respiratory condition will be compared with age and gender matched healthy controls (HC) across a 12-month period. The following will be collected at baseline, 6 and 12 months: (i) stool, (ii) oropharyngeal swab/sputum, (iii) semi-quantitative food frequency questionnaire, (iv) details of disease symptomatology, (v) health-related quality of life and (vi) psychosocial factors. Data on the intestinal and respiratory microbiomes and diet will be compared between children with a condition and HC. Correlations between dietary intake (energy, macro-nutrients and micro-nutrients), intestinal and respiratory microbiomes within each group will be explored. Data on disease symptomatology, quality of life and psychosocial factors will be compared between condition and HC cohorts.Results will be hypothesis-generating and direct future focussed studies. There is future potential for direct translation into clinical care, as diet is a highly modifiable factor.Ethics and disseminationEthics approval: Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC/18/SCHN/26). Results will be presented at international conferences and published in peer-reviewed journals.Trial registration numberNCT04071314 ]]> <![CDATA[Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial]]> https://www.researchpad.co/article/Nc3f801da-aad6-4ab9-ac1d-e20e8319945a

Introduction

Pain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.

Methods and analysis

This will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.

Ethics and dissemination

This trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.

Trial registration number

NCT03632343 (ClinicalTrials.gov).

]]>
<![CDATA[Pediatric Adenotonsillectomy Trial for Snoring (PATS): protocol for a randomised controlled trial to evaluate the effect of adenotonsillectomy in treating mild obstructive sleep-disordered breathing]]> https://www.researchpad.co/article/N3ca048ef-ca5e-44f1-ba46-5acf3f805317

Introduction

Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused.

Methods and analysis

The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0–12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study’s coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm.

Ethics and dissemination

The study protocol was approved by the institutional review board (IRB) at Children’s Hospital of Philadelphia (CHOP) on 3 October 2014 (14–0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community.

Trial registration number

NCT02562040; Pre-results.

]]>
<![CDATA[Impact of preterm birth on brain development and long-term outcome: protocol for a cohort study in Scotland]]> https://www.researchpad.co/article/N6a57e9d1-02f8-483c-8fe9-ddfec451befb

Introduction

Preterm birth is closely associated with altered brain development and is a leading cause of neurodevelopmental, cognitive and behavioural impairments across the life course. We aimed to investigate neuroanatomic variation and adverse outcomes associated with preterm birth by studying a cohort of preterm infants and controls born at term using brain MRI linked to biosamples and clinical, environmental and neuropsychological data.

Methods and analysis

Theirworld Edinburgh Birth Cohort is a prospective longitudinal cohort study at the University of Edinburgh. We plan to recruit 300 infants born at <33 weeks of gestational age (GA) and 100 healthy control infants born after 37 weeks of GA. Multiple domains are assessed: maternal and infant clinical and demographic information; placental histology; immunoregulatory and trophic proteins in umbilical cord and neonatal blood; brain macrostructure and microstructure from structural and diffusion MRI (dMRI); DNA methylation; hypothalamic–pituitary–adrenal axis activity; social cognition, attention and processing speed from eye tracking during infancy and childhood; neurodevelopment; gut and respiratory microbiota; susceptibility to viral infections; and participant experience. Main analyses include creation of novel methods for extracting information from neonatal structural and dMRI, regression analyses of predictors of brain maldevelopment and neurocognitive outcome associated with preterm birth, and determination of the quantitative predictive performance of MRI and other early life factors for childhood outcome.

Ethics and dissemination

Ethical approval has been obtained from the National Research Ethics Service (NRES), South East Scotland Research Ethics Committee (NRES numbers 11/55/0061 and 13/SS/0143 (phase I) and 16/SS/0154 (phase II)), and NHS Lothian Research and Development (2016/0255). Results are disseminated through open access journals, scientific meetings, social media, newsletters anda study website (www.tebc.ed.ac.uk), and we engage with the University of Edinburgh public relations and media office to ensure maximum publicity and benefit.

]]>
<![CDATA[Single group multisite safety trial of sibling cord blood cell infusion to children with cerebral palsy: study protocol and rationale]]> https://www.researchpad.co/article/N0661e8e0-34a1-431b-b55f-ec44518ebd51

Introduction

Cerebral palsy (CP) is the most common physical disability of childhood but has no cure. Stem cells have the potential to improve brain injury and are proposed as a therapy for CP. However, many questions remain unanswered about the most appropriate cell type, timing of infusions, dose required and associated risks. Therefore, human safety and efficacy trials are necessary to progress knowledge in the field.

Methods and analysis

This is a single group study with sample size n=12 to investigate safety of single-dose intravenous 12/12 human leucocyte antigen-matched sibling cord blood cell infusion to children with CP aged 1–16 years without immune suppression. The study is similar to a 3+3 design, where the first two groups of participants have severe CP, and the final six participants include children with all motor severities. Children will be monitored for adverse events and the duration that donor cells are detected. Assessments at baseline, 3 and 12 months will investigate safety and preliminary evidence of change in gross motor, fine motor, cognitive and quality of life outcomes.

Ethics and dissemination

Full approval was obtained from The Royal Children’s Hospital Human Research Ethics Committee, and a clinical trial notification was accepted by Australia’s Therapeutic Goods Administration. Participant guardian informed consent will be obtained before any study procedures. The main results of this study will be submitted for publication in a peer-reviewed journal.

Trial registration number

ACTRN12616000403437, NCT03087110.

]]>
<![CDATA[Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness]]> https://www.researchpad.co/article/N59518965-4e8c-4de6-9507-12e5a6725cac

Objective

To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.

Design

Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.

Setting

11 diabetes clinics in England and Wales.

Participants

Between February 2010 and August 2011, we validly randomised 308 children aged 6–18 years; 201 received the intervention.

Intervention

We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment.

Outcome measures at 3 and 6 months

Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.

Results

Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=−4.68; SE=1.74; 95%CI from −8.10 to −1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=−3.20; SE=1.33; 95% CI from −5.73 to −0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.

Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.

Conclusions

Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.

Trial registration number

ISRCTN17551624.

]]>
<![CDATA[Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial]]> https://www.researchpad.co/article/N45c254d7-7085-4c31-a5b9-2c3fb8cd48de

Introduction

Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.

Methods and analysis

This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8–16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.

Ethics and dissemination

This protocol has received ethics approval from the Royal Children’s Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.

Trial registration number

ACTRN12618001852246

]]>
<![CDATA[Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: a study protocol]]> https://www.researchpad.co/article/N8fc7316e-6f09-439a-9a9d-f0aca961c514

Introduction

Musculoskeletal deformities and gait deviations are common features in ambulatory cerebral palsy (CP). Deformity correction through lower limb orthopaedic surgery is the standard form of care aimed at improving or preserving motor function. Current research on CP care does not always take into account individual patients’ expectations and needs. There is a wide range of outcome domains and outcome measures used to assess outcome from treatment. This can lead to reporting bias and make it difficult to compare and contrast studies. A core outcome set (COS) would enhance the efficiency, relevance and overall quality of CP orthopaedic surgery research. The aim of this study is to establish a standardised COS for use in evaluating lower limb orthopaedic surgery for ambulatory children and young people with CP.

Methods/analysis

A set of outcomes domains and outcome measures will be developed as follows: (1) a qualitative evidence synthesis to identify relevant outcomes from children and young people and family perspective; (2) a scoping review to identify relevant outcomes and outcome measures; (3) qualitative research to explore the experience of key stakeholders; (4) prioritisation of outcome domains will be achieved through a two-round Delphi process with key stakeholders; (5) a final COS will be developed at a consensus meeting with representation from key stakeholder groups.

Ethics and dissemination

Ethical approval for this study was granted in the UK by the Oxfordshire Research Ethics Committee B (REC reference 19/SC/0357). Informed consent will be obtained from participants taking part in the qualitative research and Delphi process. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the project COS results.

Trial registration number

COMET registration: 1236.

PROSPERO registration number

CRD42018089538.

]]>
<![CDATA[The CoDiNOS trial protocol: an international randomised controlled trial of intravenous sildenafil versus inhaled nitric oxide for the treatment of pulmonary hypertension in neonates with congenital diaphragmatic hernia]]> https://www.researchpad.co/article/Na6fa27c9-a1f9-4be5-ba26-50839695f540

Introduction

Congenital diaphragmatic hernia (CDH) is a developmental defect of the diaphragm that impairs normal lung development, causing pulmonary hypertension (PH). PH in CDH newborns is the main determinant for morbidity and mortality. Different therapies are still mainly based on ‘trial and error’. Inhaled nitric oxide (iNO) is often the drug of first choice. However, iNO does not seem to improve mortality. Intravenous sildenafil has reduced mortality in newborns with PH without CDH, but prospective data in CDH patients are lacking.

Methods and analysis

In an open label, multicentre, international randomised controlled trial in Europe, Canada and Australia, 330 newborns with CDH and PH are recruited over a 4-year period (2018–2022). Patients are randomised for intravenous sildenafil or iNO. Sildenafil is given in a loading dose of 0.4 mg/kg in 3 hours; followed by continuous infusion of 1.6 mg/kg/day, iNO is dosed at 20 ppm. Primary outcome is absence of PH on day 14 without pulmonary vasodilator therapy and/or absence of death within the first 28 days of life. Secondary outcome measures include clinical and echocardiographic markers of PH in the first year of life. We hypothesise that sildenafil gives a 25% reduction in the primary outcome from 68% to 48% on day 14, for which a sample size of 330 patients is needed. An intention-to-treat analysis will be performed. A p-value (two-sided) <0.05 is considered significant in all analyses.

Ethics and dissemination

Ethics approval has been granted by the ethics committee in Rotterdam (MEC-2017-324) and the central Committee on Research Involving Human Subjects (NL60229.078.17) in the Netherlands. The principles of the Declaration of Helsinki, the Medical Research Involving Human Subjects Act and the national rules and regulations on personal data protection will be used. Parental informed consent will be obtained.

Trial registration number

NTR6982; Pre-results.

]]>
<![CDATA[Children on the move in Europe: a narrative review of the evidence on the health risks, health needs and health policy for asylum seeking, refugee and undocumented children]]> https://www.researchpad.co/article/5c8ad951d5eed0c4849a0d12

Background

Europe has experienced a marked increase in the number of children on the move. The evidence on the health risks and needs of migrant children is primarily from North America and Australia.

Objective

To summarise the literature and identify the major knowledge gaps on the health risks and needs of asylum seeking, refugee and undocumented children in Europe in the early period after arrival, and the ways in which European health policies respond to these risks and needs.

Design

Literature searches were undertaken in PubMed and EMBASE for studies on migrant child health in Europe from 1 January 2007 to 8 August 2017. The database searches were complemented by hand searches for peer-reviewed papers and grey literature reports.

Results

The health needs of children on the move in Europe are highly heterogeneous and depend on the conditions before travel, during the journey and after arrival in the country of destination. Although the bulk of the recent evidence from Europe is on communicable diseases, the major health risks for this group are in the domain of mental health, where evidence regarding effective interventions is scarce. Health policies across EU and EES member states vary widely, and children on the move in Europe continue to face structural, financial, language and cultural barriers in access to care that affect child healthcare and outcomes.

Conclusions

Asylum seeking, refugee and undocumented children in Europe have significant health risks and needs that differ from children in the local population. Major knowledge gaps were identified regarding interventions and policies to treat and to promote the health and well-being of children on the move.

]]>
<![CDATA[Can social robots help children in healthcare contexts? A scoping review]]> https://www.researchpad.co/article/5c8ad96ad5eed0c4849a0fa3

Objective

To review research on social robots to help children in healthcare contexts in order to describe the current state of the literature and explore future directions for research and practice.

Design

Scoping review.

Data sources

Engineering Village, IEEE Xplore, Medline, PsycINFO and Scopus databases were searched up until 10 July 2017. Only publications written in English were considered. Identified publications were initially screened by title and abstract, and the full texts of remaining publications were then subsequently screened.

Eligibility criteria

Publications were included if they were journal articles, conference proceedings or conference proceedings published as monographs that described the conceptualisation, development, testing or evaluation of social robots for use with children with any mental or physical health condition or disability. Publications on autism exclusively, robots for use with children without identified health conditions, physically assistive or mechanical robots, non-physical hardware robots and surgical robots were excluded.

Results

Seventy-three publications were included in the review, of which 50 included user studies with a range of samples. Most were feasibility studies with small sample sizes, suggesting that the robots were generally accepted. At least 26 different robots were used, with many of these still in development. The most commonly used robot was NAO. The evidence quality was low, with only one randomised controlled trial and a limited number of experimental designs.

Conclusions

Social robots hold significant promise and potential to help children in healthcare contexts, but higher quality research is required with experimental designs and larger sample sizes.

]]>
<![CDATA[Consent and recruitment: the reporting of paediatric trials published in 2012]]> https://www.researchpad.co/article/5c1fdd70d5eed0c484e9df6f

Objectives

We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets.

Methods

For this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ≤21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23.

Results

All but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets.

Conclusions

Notable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.

]]>
<![CDATA[Comparison of three tests for faecal calprotectin in children and young adults: a retrospective monocentric study]]> https://www.researchpad.co/article/5ad4dc74463d7e3c2eac1e28

Objective

Faecal calprotectin is used as a sensitive marker for gastrointestinal mucosal inflammation. We compared the performance of three different assays in a large cohort of symptomatic paediatric patients.

Design

Retrospective monocentric study.

Setting

Inpatients and outpatients of a tertiary referral centre for paediatric gastroenterology.

Participants

304 symptomatic patients (163 males, aged 2–20 years) with active inflammatory bowel disease (IBD/A, n=130), IBD in clinical remission (IBD/R, n=62), other intestinal diseases (n=45) and controls without identified intestinal disease (n=67).

Interventions

Calprotectin was measured in homogenised faecal samples with three tests (A: EliA Calprotectin, Phadia AB, Sweden; B: PhiCal, Calpro AS, Norway; C: EK-Cal, Bühlmann Laboratories, Switzerland).

Outcomes

Concordance between tests was calculated using Kendall's τ coefficient.

Results

IBD/A and controls were correctly classified as 97.7%/82.1% (A), 97.7%/85.1% (B) and 98.4%/62.7% (C; not significant). Test C tended to have higher calprotectin values with a lower specificity compared to tests A and B. The concordance between two tests was 0.835 for tests A and B, 0.782 for tests A and C and 0.765 for tests B and C.

Conclusions

All three tests are very sensitive for detecting mucosal inflammation, but major differences exist between specificity and absolute values. It is highly advisable to use the test of the same manufacturer for follow-up and to monitor for disease activity.

]]>
<![CDATA[Associations between physical activity and asthma, eczema and obesity in children aged 12–16: an observational cohort study]]> https://www.researchpad.co/article/5c64467fd5eed0c484c2be6c

Objectives

To compare the physical activity of adolescents with three common long-term conditions (asthma, eczema and obesity) with adolescents without these conditions.

Design

Cross-sectional and longitudinal analyses of adolescents at ages 12, 14 and 16 in a large UK cohort study.

Setting

The Avon Longitudinal Study of Parents and Children.

Participants

6473 adolescents with complete accelerometer data at at least one time point.

Methods

Mean minutes of moderate to vigorous intensity physical activity (MVPA) and sedentary time per day were derived from accelerometer-based measurements at ages 12, 14 and 16. Obesity was defined at each time point from height and weight measurements. Parents reported doctor-assessed asthma or eczema. Cross-sectional and longitudinal regression models examined any differences in MVPA or sedentary time for adolescents with asthma, eczema or obesity compared with those without.

Results

In longitudinal models, boys engaged in an average of 69.7 (95% CI 67.6 to 71.7) min MVPA at age 12, declining by 3.1 (95% CI 2.6 to 3.6) min/year while girls’ average MVPA was 47.5 (95% CI 46.1 to 48.9) min at age 12, declining by 1.8 (95% CI 1.5 to 2.1) min/year. There was no strong evidence of differences in physical activity patterns of those with and without asthma or eczema. Obese boys engaged in 11.1 (95% CI 8.7 to 13.6) fewer minutes of MVPA, and obese girls in 5.0 (95% CI 3.3 to 6.8) fewer minutes than their non-obese counterparts. Cross-sectional models showed comparable findings.

Conclusions

Mean minutes of MVPA per day did not differ between adolescents with asthma or eczema and those without, but obese adolescents engaged in fewer minutes of MVPA. Findings reinforce the need for strategies to help obese adolescents be more active but suggest no need to develop bespoke physical activity strategies for adolescents with mild asthma or eczema.

]]>
<![CDATA[Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial—a study protocol]]> https://www.researchpad.co/article/5c9e5792d5eed0c48423fdbc

Introduction

Gabapentin is currently used ‘off-label’ in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking.

Objectives

The GABA-1 trial aims to compare the efficacy and safety of gabapentin liquid formulation relative to tramadol and to explore the pharmacokinetics of both drugs in the treatment of chronic, neuropathic or mixed pain in the paediatric population.

Methods and analysis

The trial is a multicentre, double-blind, double-dummy, randomised, active-controlled, non-inferiority trial. Participants aged from 3 months to <18 years of age with moderate to severe (≥4/10 in age-appropriate pain scales) chronic neuropathic or mixed pain will be recruited in 14 clinical sites in eight European countries. A total of 94 subjects will be randomised to receive gabapentin and tramadol placebo or tramadol and gabapentin placebo throughout 16–19 weeks (including 3 weeks of titration [optimisation period], 12 weeks of treatment at a stable dose [maintenance period] and 1–4 weeks of tapering [discontinuation period]). The primary objective is to assess the efficacy of gabapentin relative to tramadol for the treatment of moderate to severe chronic neuropathic or mixed pain by comparing the difference in average pain scores (assessed by age-appropriate pain scales) between intervention arms after 15 weeks of treatment. Secondary objectives include the assessment of the safety, quality of life and global satisfaction with treatment and the description of the pharmacokinetic–pharmacodynamic relationship of gabapentin liquid formulation and tramadol oral drops to validate the recommended paediatric doses. Only rescue pain medication by paracetamol and/or ibuprofen is allowed during the trial.

Ethics and dissemination

Ethic approval was obtained in the eight participating countries. Results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Trial registration numbers

2014-004851-30 and NCT02722603.

Trial status

Ongoing research study, currently recruiting.

]]>
<![CDATA[Cohort profile: Children in Need Census (CIN) records of children referred for social care support in England]]> https://www.researchpad.co/article/5c9e5789d5eed0c48423fc8b

Purpose

The Children in Need Census (CIN) is a case-based administrative dataset on children referred to social care services in England. CIN includes information on the ‘needs’ of children, and whether they received social care support. Local and national government bodies in England currently use CIN for evaluation purposes. Data are accessible to researchers under certain conditions, allowing researchers to investigate the health implications of adverse childhood experiences. However, CIN suffers from lack of metadata, meaning it can be challenging for researchers to process and interpret data, particularly if researchers are unfamiliar with the English children’s social care system. To address this issue, we provide the background to CIN and describe the available data from 2008 to 2016.

Participants

CIN is derived from case records held by English local authorities on all children referred to children’s social care for a ‘needs assessment’, regardless of whether they are eventually assessed as ‘in need of social care support’. Local authorities submit these case records to the UK Department for Education for collation. CIN holds information on an estimated 2.76 million children from October 2008 to March 2016. Since 2013/2014, just under 900 000 children have been recorded in the CIN annually, equivalent to around 8% of children in England (annual prevalence). Approximately, 650 000 children enter or renter the dataset each year, equivalent to 5% of children in England (annual incidence).

Data summary

Of the estimated 2.76 million children in the data, 50% are male and 47% female. 45% are referred to children’s social care services due to abuse or neglect. 10.7% of children in CIN went onto a child protection plan, meaning they were judged to be (at risk of) suffering significant harm.

Future plans

CIN data collection is annual and ongoing. Data from the most recent census period typically become available for researchers in the following Spring.

]]>