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Chest radiograph findings in children aged 2-59 months hospitalised with community-acquired pneumonia, prior to the introduction of pneumococcal conjugate vaccine in India: a prospective multisite observational study

Por: Awasthi · S. · Rastogi · T. · Mishra · N. · Chauhan · A. · Mohindra · N. · Shukla · R. C. · Agarwal · M. · Pandey · C. M. · Kohli · N. · Study Group · C.
Objectives

The current study was a hospital-based surveillance of cases hospitalised with WHO-defined community-acquired pneumonia in children aged 2–59 months, to assess the radiological abnormalities in chest X-rays and to identify the demographic and clinical correlates of specific radiological abnormalities, in residents of prespecified districts of Uttar Pradesh and Bihar, India.

Design

Prospective, active, hospital-based surveillance.

Setting

Multisite study conducted in a network of 117 secondary/tertiary care hospitals in four districts of Uttar Pradesh and Bihar, India.

Participants

Included were children aged 2–59 months, hospitalised with community-acquired pneumonia, residing in the project district, with duration of illness

Main outcome measure

Concordant radiological abnormalities in the chest X-rays.

Results

From January 2015 to April 2017, 3214 cases were recruited and in 99.40% (3195/3214) chest X-rays were available, among which 88.54% (2829/3195) were interpretable. Relevant radiological abnormalities were found in 34.53% (977/2829, 95% CI 32.78 to 36.28). These were primary end point pneumonia alone or with other infiltrates in 22.44% (635/2829, 95% CI 20.90% to 23.98%) and other infiltrates in 12.09% (342/2829; 95% CI 10.88% to 13.29%). There was a statistically significant interdistrict variation in radiological abnormalities. Statistically significantly higher proportion of abnormal chest X-rays were found in girls, those with weight-for-age z-score ≤–3SD, longer duration of fever, pallor and with exposure to biomass fuel.

Conclusions

Among hospitalised cases of community-acquired pneumonia, almost one-third children had abnormal chest radiographs, which were higher in females, malnourished children and those with longer illnesses; and an intra-district variation was observed.

Cows Milk Fat Obesity pRevention Trial (CoMFORT): a primary care embedded randomised controlled trial protocol to determine the effect of cows milk fat on child adiposity

Por: Vanderhout · S. M. · Aglipay · M. · Birken · C. · Li · P. · O'Connor · D. L. · Thorpe · K. · Constantin · E. · Davis · M.-A. · Feldman · M. · Ball · G. D. C. · Janus · M. · Jüni · P. · Junker · A. · Laupacis · A. · L'Abbe · M. · Manson · H. · Moretti · M. E. · Persaud · N. · Omand · J. A.
Introduction

Cow’s milk is a dietary staple for children in North America. Though clinical guidelines suggest children transition from whole (3.25% fat) milk to reduced (1% or 2%) fat milk at age 2 years, recent epidemiological evidence supports a link between whole milk consumption and lower adiposity in children. The purpose of this trial is to determine which milk fat recommendation minimises excess adiposity and optimises child nutrition and growth.

Methods and analysis

Cow’s Milk Fat Obesity pRevention Trial will be a pragmatic, superiority, parallel group randomised controlled trial involving children receiving routine healthcare aged 2 to 4–5 years who are participating in the TARGet Kids! practice-based research network in Toronto, Canada. Children (n=534) will be randomised to receive one of two interventions: (1) a recommendation to consume whole milk or (2) a recommendation to consume reduced (1%) fat milk. The primary outcome is adiposity measured by body mass index z-score and waist circumference z-score; secondary outcomes will be cognitive development (using the Ages and Stages Questionnaire), vitamin D stores, cardiometabolic health (glucose, high-sensitivity C-reactive protein, non-high density lipoprotein (non-HDL), low density lipoprotein (LDL), triglyceride, HDL and total cholesterol, insulin and diastolic and systolic blood pressure), sugary beverage and total energy intake (measured by 24 hours dietary recall) and cost effectiveness. Outcomes will be measured 24 months postrandomisation and compared using analysis of covariance (ANCOVA), adjusting for baseline measures.

Ethics and dissemination

Ethics approval has been obtained from Unity Health Toronto and The Hospital for Sick Children. Results will be presented locally, nationally and internationally and published in a peer-reviewed journal. The findings may be helpful to nutrition guidelines for children in effort to reduce childhood obesity using a simple, inexpensive and scalable cow’s milk fat intervention.

Trial registration number

NCT03914807; pre-results.

Clinical practice guidelines for acute otitis media in children: a systematic review and appraisal of European national guidelines

Por: Suzuki · H. G. · Dewez · J. E. · Nijman · R. G. · Yeung · S.
Objectives

To appraise European guidelines for acute otitis media (AOM) in children, including methodological quality, level of evidence (LoE), astrength of recommendations (SoR), and consideration of antibiotic stewardship.

Design

Systematic review of the literature.

Data sources

Three-pronged search of (1) databases: Medline, Embase, Cochrane library, Guidelines International Network and Trip Medical Database; (2) websites of European national paediatric associations and (3) contact of European experts. Data were collected between January 2017 and February 2018.

Eligibility criteria

National guidelines of European countries for the clinical management of AOM in children aged

Data extraction and synthesis

Data were extracted using tables constructed by the research team. Guidelines were graded using AGREE II criteria. LoE and SoR were compared. Guidelines were assessed for principles of antibiotic stewardship.

Results

AOM guidelines were obtained from 17 or the 32 countries in the European Union or European Free Trade Area. The mean AGREE II score was ≤41% across most domains. Diagnosis of AOM was based on similar signs and symptoms. The most common indication for antibiotics was tympanic membrane perforation/otorrhoea (14/15; 93%). The majority (15/17; 88%) recommended a watchful waiting approach to antibiotics. Amoxicillin was the most common first-line antibiotic (14/17; 82%). Recommended treatment duration varied from 5 to 10 days. Seven countries advocated high-dose (75–90 mg/kg/day) and five low-dose (30–60 mg/kg/day) amoxicillin. Less than 60% of guidelines used a national or international scale system to rate level of evidence to support recommendations. Under half of the guidelines (7/17; 41%) referred to country-specific microbiological and antibiotic resistance data.

Conclusions

Guidelines for managing AOM were similar across European countries. Guideline quality was mostly weak, and it often did not refer to country-specific antibiotic resistance patterns. Coordinating efforts to produce a core guideline which can then be adapted by each country may help improve overall quality and contribute to tackling antibiotic resistance.

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

Por: Coffey · M. J. · McKay · I. R. · Doumit · M. · Chuang · S. · Adams · S. · Stelzer-Braid · S. · Waters · S. A. · Kasparian · N. A. · Thomas · T. · Jaffe · A. · Katz · T. · Ooi · C. Y.
Introduction

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 analysis

The 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 dissemination

Ethics 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 number

NCT04071314

Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol

Por: Ginsburg · A. S. · Nkwopara · E. · Macharia · W. · Ochieng · R. · Waiyego · M. · Zhou · G. · Karasik · R. · Xu · S. · Ansermino · J. M.
Introduction

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 analysis

The 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 dissemination

This 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 number

NCT03920761.

Hypertensive disorders of pregnancy and risk of asthma in offspring: protocol for a systematic review and meta-analysis

Por: Li · P. · Xiong · T. · Hu · Y.
Introduction

Hypertensive disorders of pregnancy (HDP), one of the most common obstetrical complications, has been reported to have a controversial relationship with the increased risk of asthma in offspring. No systematic review of this topic has been performed. The aim of this systematic review will be to summarise the available evidence examining the association between HDP and the risk of asthma in offspring.

Methods and analysis

We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analysis of Observational Studies in Epidemiology guidelines. A systematic search of the PubMed, Embase, Cochrane and Web of Science databases will be performed using a detailed search strategy from database inception through 31 December 2019. Cohort, case-control and cross-sectional studies that report a diagnosis of maternal HDP and asthma in offspring will be included. Studies will be limited to the English language and include only human participants. Two independent reviewers will conduct the study selection, data extraction and risk of bias assessments using a standardised data extraction form. A meta-analysis will be performed to calculate overall pooled estimates using the generic inverse variance method. The data will be synthesised by either fixed-effect or random effects models according to heterogeneity tests. All analyses will be performed in Stata 14 and RevMan 5.3. High-quality evidence of the relationship between HDP and the risk of asthma in exposed offspring will be identified through the synthesis of current studies. In addition, the results of subgroup analyses and related secondary outcomes will be reported. The following will be concluded: (i) whether HDP increases the risk of asthma in offspring, (ii) whether HDP affects the severity of asthma in exposed offspring and (iii) whether possible differences in the risk of asthma among different HDP subgroups exist.

Ethics and dissemination

There is no requirement for ethics approval because the meta-analysis and systematic review will be based on published data. It is anticipated that the dissemination of results will take place at conferences and through publication in a peer-reviewed journal.

Core outcome set in paediatric sepsis in low- and middle-income countries: a study protocol

Por: Wooldridge · G. · Murthy · S. · Kissoon · N.
Introduction

Sepsis is the leading cause of death in children worldwide and has recently been declared a major global health issue. New interventions and a concerted effort to enhance our understanding of sepsis are required to address the huge burden of disease, especially in low- and middle-income countries (LMIC) where it is highest. An opportunity therefore exists to ensure that ongoing research in this area is relevant to all stakeholders and is of consistently high quality. One method to address these issues is through the development of a core outcome set (COS).

Methods and analysis

This study protocol outlines the phases in the development of a core outcome set for paediatric sepsis in LMIC. The first step involves performing a systematic review of all outcomes reported in the research of paediatric sepsis in low middle-income countries. A three-stage international Delphi process will then invite a broad range of participants to score each generated outcome for inclusion into the COS. This will include an initial two-step online survey and finally, a face-to-face consensus meeting where each outcome will be reviewed, voted on and ratified for inclusion into the COS.

Ethics and dissemination

No core outcome sets exist for clinical trials in paediatric sepsis. This COS will serve to not only highlight the heavy burden of paediatric sepsis in this setting and aid collaboration and participation between all stakeholders, but to promote ongoing essential high quality and relevant research into the topic. A COS in paediatric sepsis in LMIC will advocate for a common language and facilitate interpretation of findings from a variety of settings. A waiver for ethics approval has been granted by University of British Columbia Children’s and Women’s Research Ethics Board.

Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial

Por: Jibb · L. · Nathan · P. C. · Breakey · V. · Fernandez · C. · Johnston · D. · Lewis · V. · McKillop · S. · Patel · S. · Sabapathy · C. · Strahlendorf · C. · Victor · J. C. · Moretti · M. E. · Nguyen · C. · Hundert · A. · Cassiani · C. · El-Khechen Richandi · G. · Insull · H. · Hamilton · R
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).

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

Por: Wang · R. · Bakker · J. P. · Chervin · R. D. · Garetz · S. L. · Hassan · F. · Ishman · S. L. · Mitchell · R. B. · Morrical · M. G. · Naqvi · S. K. · Radcliffe · J. · Riggan · E. I. · Rosen · C. L. · Ross · K. · Rueschman · M. · Tapia · I. E. · Taylor · H. G. · Zopf · D. A. · Redline · S.
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.

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness

Por: Noyes · J. · Allen · D. · Carter · C. · Edwards · D. · Edwards · R. T. · Russell · D. · Russell · I. T. · Spencer · L. H. · Sylvestre · Y. · Whitaker · R. · Yeo · S. T. · Gregory · J. W.
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.

Single group multisite safety trial of sibling cord blood cell infusion to children with cerebral palsy: study protocol and rationale

Por: Crompton · K. · Novak · I. · Fahey · M. · Badawi · N. · Wallace · E. · Lee · K. · Mechinaud-Heloury · F. · Colditz · P. B. · Elwood · N. · Edwards · P. · Reddihough · D.
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.

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

Por: Efron · D. · Taylor · K. · Payne · J. M. · Freeman · J. L. · Cranswick · N. · Mulraney · M. · Prakash · C. · Lee · K. J. · Williams · K.
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

Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: a study protocol

Por: Almoajil · H. · Dawes · H. · Hopewell · S. · Toye · F. · Jenkinson · C. · Theologis · T.
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.

Impact of preterm birth on brain development and long-term outcome: protocol for a cohort study in Scotland

Por: Boardman · J. P. · Hall · J. · Thrippleton · M. J. · Reynolds · R. M. · Bogaert · D. · Davidson · D. J. · Schwarze · J. · Drake · A. J. · Chandran · S. · Bastin · M. E. · Fletcher-Watson · S.
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

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.

Perspectives on simulation-based training from paediatric healthcare providers in Nigeria: a national survey

Por: Umoren · R. · Ezeaka · V. C. · Fajolu · I. B. · Ezenwa · B. N. · Akintan · P. · Chukwu · E. · Spiekerman · C.
Objectives

The objective of this study was to explore the access to, and perceived utility of, various simulation modalities by in-service healthcare providers in a resource-scarce setting.

Setting

Paediatric training workshops at a national paediatric conference in Nigeria.

Participants

All 200 healthcare workers who attended the workshop sessions were eligible to participate. A total of 161 surveys were completed (response rate 81%).

Primary and secondary outcome measures

A paper-based 25-item cross-sectional survey on simulation-based training (SBT) was administered to a convenience sample of healthcare workers from secondary and tertiary healthcare facilities.

Results

Respondents were mostly 31–40 years of age (79, 49%) and women (127, 79%). Consultant physicians (26, 16%) and nurses (56, 35%) were in both general (98, 61%) and subspecialty (56, 35%) practice. Most had 5–10 years of experience (62, 37%) in a tertiary care setting (72, 43%). Exposure to SBT varied by profession with physicians more likely to be exposed to manikin-based (29, 30% physicians vs 12, 19% nurses, p

Conclusions

The access of healthcare workers to SBT is limited in resource-scarce settings. While acknowledging the challenges, respondents identified many areas in which SBT may be useful, including skills acquisition, skills practice and communication training. Healthcare workers were open to the use of online SBT and expressed the need to expand SBT beyond the current scope for health professional training in Nigeria.

Dance PREEMIE, a Dance PaRticipation intervention for Extremely prEterm children with Motor Impairment at prEschool age: an Australian feasibility trial protocol

Por: Cameron · K. L. · McGinley · J. L. · Allison · K. · Fini · N. A. · Cheong · J. L. Y. · Spittle · A. J.
Introduction

Children born extremely preterm (EP:

Methods and analysis

This feasibility case series trial will recruit EP/ELBW children with motor impairment (n=10) from the Victorian Infant Collaborative Study 2016/2017 cohort, a prospective longitudinal cohort study. Up to 10 community-based dance teachers will be recruited and provided with physiotherapy-led training and support to facilitate the participation of EP/ELBW children in community dance classes. A mixed-methods approach (quantitative and qualitative) will be used to analyse the primary aim, to determine the feasibility of the intervention from the perspectives of families and dance teachers.

Ethics and dissemination

This study is approved by the Human Research Ethics Committees of The Royal Children’s Hospital and The Royal Women’s Hospital, Melbourne. Study outcomes will be disseminated through conference presentations, peer-reviewed publications and social media.

Trial registration number

ACTRN12619001266156

Vitamin D supplementation to improve pregnancy and perinatal outcomes: an overview of 42 systematic reviews

Por: Bialy · L. · Fenton · T. · Shulhan-Kilroy · J. · Johnson · D. W. · McNeil · D. A. · Hartling · L.
Objective

To review the evidence to assess effectiveness of vitamin D supplementation during pregnancy and associations of serum vitamin D levels with perinatal outcomes.

Design

Overview of systematic reviews (SRs).

Data sources

Searches conducted in January 2019: Ovid Medline (1946–), Cochrane Library databases.

Eligibility criteria for selecting studies

Two reviewers independently screened titles and abstracts, and full texts using predefined inclusion criteria: SRs evaluating vitamin D supplementation in pregnant women and/or examining the association between serum vitamin D levels reporting at least one predefined perinatal outcome. Only SRs with high AMSTAR scores were analysed.

Data extraction and synthesis

Data were extracted independently by one reviewer and checked by a second. Results were assessed for quality independently by two reviewers using GRADE criteria.

Results

Thirteen SRs were included, synthesising evidence from 204 unique primary studies. SRs of randomised controlled trials (RCTs) with the highest level of evidence showed no significant benefit from vitamin D in terms of preterm birth (RR 1.00 (95% CI 0.77, 1.30); high quality), pre-eclampsia (RR 0.91 (0.45, 1.86); low quality), gestational diabetes (RR 0.65 (0.39, 1.08); very low quality), stillbirth (RR 0.75 (0.50, 1.12); high quality), low birth weight (RR 0.74 (0.47, 1.16); low quality), caesarean section (RR 1.02 (0.93, 1.12); high quality). A significant difference was found for small for gestational age (RR 0.72 (0.52, 0.99); low quality). SRs of observational studies showed associations between vitamin D levels and preterm birth (RR 1.19 (1.08, 1.31); moderate quality), pre-eclampsia (RR 1.57 (1.21, 2.03) for 25-hydroxy vitamin D (25 (OH)D)

Conclusion

There is some evidence from SRs of observational studies for associations between vitamin D serum levels and some outcomes; however SRs examining effectiveness from RCTs showed no effect of vitamin D supplementation in pregnancy with the exception of one predefined outcome, which had low quality evidence. Credibility of the evidence in this field is compromised by study limitations (in particular, the possibility of confounding among observational studies), inconsistency, imprecision and potential for reporting and publication biases.

Application of a Common Data Model (CDM) to rank the paediatric user and prescription prevalence of 15 different drug classes in South Korea, Hong Kong, Taiwan, Japan and Australia: an observational, descriptive study

Por: Brauer · R. · Wong · I. C. K. · Man · K. K. · Pratt · N. L. · Park · R. W. · Cho · S.-Y. · Li · Y.-C. · Iqbal · U. · Nguyen · P.-A. A. · Schuemie · M.
Objective

To measure the paediatric user and prescription prevalence in inpatient and ambulatory settings in South Korea, Hong Kong, Taiwan, Japan and Australia by age and gender. A further objective was to list the most commonly used drugs per drug class, per country.

Design and setting

Hospital inpatient and insurance paediatric healthcare data from the following databases were used to conduct this descriptive drug utilisation study: (i) the South Korean Ajou University School of Medicine database; (ii) the Hong Kong Clinical Data Analysis and Reporting System; (iii) the Japan Medical Data Center; (iv) Taiwan’s National Health Insurance Research Database and (v) the Australian Pharmaceutical Benefits Scheme. Country-specific data were transformed into the Observational Medical Outcomes Partnership Common Data Model.

Patients

Children (≤18 years) with at least 1 day of observation in any of the respective databases from January 2009 until December 2013 were included.

Main outcome measures

For each drug class, we assessed the per-protocol overall user and prescription prevalence rates (per 1000 persons) per country and setting.

Results

Our study population comprised 1 574 524 children (52.9% male). The highest proportion of dispensings was recorded in the youngest age category (

Conclusions

Country-specific paediatric drug utilisation patterns were described, ranked and compared between four East Asian countries and Australia. The widespread use of mucolytics in East Asia warrants further investigation.

Sex-specific effects of nutritional supplements in infants born early or small: protocol for an individual participant data meta-analysis (ESSENCE IPD-MA)

Por: Lin · L. · Crowther · C. · Gamble · G. · Bloomfield · F. · Harding · J. E. · The ESSENCE IPD-MA Group · Agosti · Atkinson · Biasini · Da Cunha · Embleton · Faraz · Fewtrell · Lamy Filho · Fusch · Gianni · Kanmaz · Koo · Litmanovitz · Lucas · Morgan · Mukhopadhyay · Neri · Picaud · R
Introduction

Preterm and small for gestational age (SGA) infants are at increased risk of poor growth, disability and delayed development. While growing up they are also at increased risk of obesity, diabetes and later heart disease. The risk of such adverse outcomes may be altered by how preterm and SGA infants are fed after birth. Faltering postnatal growth is common due to failure to achieve recommended high energy and protein intakes, and thus preterm and SGA infants are often provided with supplemental nutrition soon after birth. Enhanced nutrition has been associated with improved early growth and better cognitive development. However, limited evidence suggests that faster growth may increase the risk for later adiposity, metabolic and cardiovascular disease, and that such risks may differ between girls and boys.

Methods and analysis

We will search Ovid MEDLINE, Embase, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, controlled-trials.com, ClinicalTrials.gov and anzctr.org.au for randomised trials that studied the effects of macronutrient supplements for preterm and SGA infants on (i) developmental and metabolic and (ii) growth outcomes after hospital discharge. The outcomes will be (i) cognitive impairment and metabolic risk (co-primary) and (ii) body mass index. Individual participant data (IPD) from all available trials will be included using an intention-to-treat approach. A one-stage procedure for IPD meta-analysis (MA) will be used, accounting for clustering of participants within studies. Exploratory subgroup analyses will further investigate sources of heterogeneity, including sex and size of infants, different timing, duration and type of supplements.

Ethics and dissemination

This IPD-MA is approved by the University of Auckland Human Participants Ethics Committee (reference number: 019874). Individual studies have approval from relevant local ethics committees. Results will be disseminated in a peer-reviewed journal and presented at international conferences.

PROSPERO registration number

CRD42017072683

Training attention in children with acquired brain injury: a study protocol of a randomised controlled trial of the TALI attention training programme

Por: McKay · E. · Richmond · S. · Kirk · H. · Anderson · V. · Catroppa · C. · Cornish · K.
Introduction

Childhood inattention has been linked with poor academic outcomes, and increased lifetime social, occupational and psychiatric morbidity. Children with an acquired brain injury (ABI) are particularly susceptible to attention deficits and may benefit from interventions aimed at enhancing attention. The primary objective of this study is to evaluate the short-term efficacy of the TALI Train programme, compared with a placebo, on the outcome of attention in children with ABI.

Methods and analysis

The study is a parallel, double-blind, randomised controlled trial. Participants will consist of 80 children with a diagnosis of ABI aged 4–9 years 11 months. Participants will be randomly allocated to either (1) TALI Train (intervention group), an adaptive game-based attention training programme, or (2) a non-adaptive placebo programme (control group). Both programmes are delivered on a touchscreen tablet, and children complete five 20 min sessions per week for a 5-week period at home. Assessment of selective, sustained and executive attention (primary outcomes), and behavioural attention, working memory, social skills and mathematics ability (secondary outcomes) will occur at baseline, post-training, and at 3-month and 6-month follow-up to assess immediate and long-term efficacy of TALI Train compared with placebo. Assessments will be completed at the Royal Children’s Hospital in Melbourne, Australia. All assessments and analyses will be undertaken by researchers blinded to group membership. Latent growth curve modelling will be employed to examine primary and secondary outcomes.

Ethics and dissemination

Ethics approval has been obtained from the Royal Children’s Hospital Human Research Ethics Committee (HREC) (38132) and the Monash University HREC (17446). Results will be disseminated through peer-reviewed journals, conference presentations, media outlets, the internet and various community/stakeholder activities.

Trial registration number

ACTRN12619000511134.

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