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Systematic review of the effectiveness of complementary and alternative medicine on nausea and vomiting in children with cancer: a study protocol

Por: Ho · K. Y. · Lam · K. K. W. · Chung · J. O. K. · Xia · W. · Cheung · A. T. · Ho · L. K. · Chiu · S. Y. · Chan · G. C. F. · LI · H. C. W.
Introduction

Nausea and vomiting are two most common symptoms reported by children with cancer when they undergo active treatment. However, pharmacological treatment is not sufficient to manage these two symptoms, with over 40% of children still experience nausea and vomiting after receiving antiemetics. There has been an exponential growth of studies to demonstrate the effectiveness of different complementary complementary medicine (CAM) to control nausea and vomiting during cancer treatment. Appropriate application of CAM enhances the effectiveness of antiemetics, thus reducing the symptom burden on children as well as improving their general condition and quality of life during cancer treatment. Nevertheless, it remains unclear which CAM is the best approach to help children to prevent or reduce nausea and vomiting during and after cancer treatment. This paper describes a protocol for identifying, analysing and synthesising research evidence on the effectiveness of CAM on nausea and vomiting in children with cancer.

Methods and analysis

A total of 10 databases will be searched to identify appropriate literature: MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, CINAHL, PsycINFO, LILACS, OpenSIGLE, the Chinese Biomedical Literature Database, the Chinese Medical Current Contents and the Chinese National Knowledge Infrastructure. All randomised controlled trials which meet the inclusion criteria will be included. The primary outcome is the changes in nausea and vomiting either assessed by self-reported and/or objective measures. Review Manager 5.3 will be used to synthesise the data, calculate the treatment effects, perform any subgroup analysis and assess the risk of bias.

Ethical and dissemination

The results will be presented at international conferences and published in peer-reviewed journals. As no individual data will be involved in this review, ethical approval is not required.

PROSPERO registration number

CRD42019135404.

Development and validation of a questionnaire for the assessment of the knowledge, management and reporting ADR in paediatrics by healthcare teams (QUESA-P)

Por: Tavares · S. S. · Cruz · L. N. · Castro · J. · Lopes · L. C.
Objective

We aimed to develop and validate a new instrument called Questionnaire for the assessment of the knowledge, management and reporting ADR in Paediatrics by Healthcare teams (QUESA-P).

Design

This is a cross-sectional study.

Settings and participants

Teams of healthcare professionals (HCP) that lead with pharmacological therapy in Paediatrician’s sector (Paediatric-HCP) in seven public hospitals in Brazil.

Outcome

An assessment of the knowledge and current management of ADR in Paediatric-HCP.

Methods

We developed and validated QUESA-P, using a standardised procedure which included item development and psychometric prevalidation using Cronbach’s Alpha, item-total correlation and test–retest validity for internal consistency and reliability. External criterion was used as criterion validation (the instrument was applied to the focus group expert vs focus group team of Paediatric-HCP in hospitals). The focus group of experts who participated in psychometrics was asked to respond to the QUESA-P twice in order to assess test-retest reliability. The content validity of the initial questionnaire was assessed by the Delphi method and pilot test. Subsequently, we made minor revisions and finalized the QUESA-P

Results

Selection of domains and facets were based on literature review made in duplicate by authors. Content validity was done by trial of different examiners (panellists, n=16), conducting analysis through Delphi method (three rounds). The QUESA-P was constructed with three domains. The intraclass correlations (0.80) and the Cronbach’s alpha coefficient (0.82), indicated adequate test–retest reliability and internal consistency for each domain. The application of the QUESA to 61 Paediatric-HCP in hospital resulted in lower mean score of 42.1 ± 3.4 in all domains when compared with expert teams (n= 46) 48.2 ± 3.7 (p

Conclusion

The selected domains can be used to check weaknesses in the identification, management and reporting of suspected ADR by Paediatric-HCP in Brazil.

Preventive strategies and factors associated with surgically treated necrotising enterocolitis in extremely preterm infants: an international unit survey linked with retrospective cohort data analysis

Por: Adams · M. · Bassler · D. · Darlow · B. A. · Lui · K. · Reichman · B. · Hakansson · S. · Norman · M. · Lee · S. K. · Helenius · K. K. · Lehtonen · L. · San Feliciano · L. · Vento · M. · Moroni · M. · Beltempo · M. · Yang · J. · Shah · P. S. · on behalf of the International Network for
Objectives

To compare necrotising enterocolitis (NEC) prevention practices and NEC associated factors between units from eight countries of the International Network for Evaluation of Outcomes of Neonates, and to assess their association with surgical NEC rates.

Design

Prospective unit-level survey combined with retrospective cohort study.

Setting

Neonatal intensive care units in Australia/New Zealand, Canada, Finland, Israel, Spain, Sweden, Switzerland and Tuscany (Italy).

Patients

Extremely preterm infants born between 240 to 286 weeks’ gestation, with birth weights

Exposures

NEC prevention practices (probiotics, feeding, donor milk) using responses of an on-line pre-piloted questionnaire containing 10 questions and factors associated with NEC in literature (antenatal steroids, c-section, indomethacin treated patent ductus arteriosus and sepsis) using cohort data.

Outcome measures

Surgical NEC rates and death following NEC using cohort data.

Results

The survey response rate was 91% (153 units). Both probiotic provision and donor milk availability varied between 0%–100% among networks whereas feeding initiation and advancement rates were similar in most networks. The 9792 infants included in the cohort study to link survey results and cohort outcomes, revealed similar baseline characteristics but considerable differences in factors associated with NEC between networks. 397 (4.1%) neonates underwent NEC surgery, ranging from 2.4%–8.4% between networks. Standardised ratios for surgical NEC were lower for Australia/New Zealand, higher for Spain, and comparable for the remaining six networks.

Conclusions

The variation in implementation of NEC prevention practices and in factors associated with NEC in literature could not be associated with the variation in surgical NEC incidence. This corroborates the current lack of consensus surrounding the use of preventive strategies for NEC and emphasises the need for research.

'Your Tube: the role of different diets in children who are gastrostomy fed: protocol for a mixed methods exploratory sequential study

Por: Taylor · J. · O'Neill · M. · Maddison · J. · Richardson · G. · Hewitt · C. · Horridge · K. · Cade · J. · McCarter · A. · Beresford · B. · Fraser · L. K.
Introduction

Increasing numbers of children require having all, or part, of their nutritional intake via gastrostomy. More parents are using home-blended meals to feed their children, with many reporting beneficial effects such as improved gastro-oesophageal reflux, less constipation and less distress in their child.

This study aims to identify the important outcomes of tube feeding in this population, compare the safety, outcomes and resource use of those on a home-blended diet compared with a formula diet and assess feasibility of long-term follow-up of children recruited to this study.

Methods and analyses

This is a mixed methods study of children (aged 6 months to 18 years) who are gastrostomy feed dependent recruited via general, community and specialist paediatric and dietetic services.

Workstream 1 (WS1): a qualitative study involving semistructured interviews with parents (n~20) and young people (n~5–10), and focus groups with health professionals (n~25), will provide evidence of appropriate outcome measures and the feasibility/acceptability of proposed data collection methods for WS2. It will gather data on: desired outcomes of gastrostomy feeding, variability in diets and reasons; use of oral feeding; perceived benefits of the alternative diets, resources associated with gastrostomy feeding and safety issues. Data will be analysed using thematic analysis.

WS2: a cohort study of 300 children who are gastrostomy fed. Data will be collected at months 0, 9 and 18 from parents, children (if appropriate) and clinicians using standardised measures and questionnaires developed specifically for the study. Data collected will include gastrointestinal symptoms, health and other outcomes (child, parent), dietary intake, anthropometry, healthcare usage, safety outcomes and resource use. Outcomes in the home-blended and formula groups will be compared using appropriate multiple regression analyses.

Ethics and dissemination

The study has been approved by a research ethics committee (REC reference: 19/YH/0028). Results will be disseminated through publications and presentations for professionals and families.

Study registration number

ISRCTN13977361.

Randomised controlled pilot feasibility trial of an early intervention programme for young infants with neurodevelopmental impairment in Uganda: a study protocol

Por: Nampijja · M. · Webb · E. · Nanyunja · C. · Sadoo · S. · Nalugya · R. · Nyonyintono · J. · Muhumuza · A. · Ssekidde · M. · Katumba · K. · Magnusson · B. · Kabugo · D. · Cowan · F. M. · Martinez-Biarge · M. · Zuurmond · M. · Morgan · C. · Lester · D. · Seeley · J. · Tann · C. J.
Introduction

Early intervention programmes (EIPs) for infants with neurodevelopmental impairment have been poorly studied especially in low-income settings. We aim to evaluate the feasibility and acceptability of a group participatory EIP, the ‘ABAaNA EIP’, for young children with neurodevelopmental impairment in Uganda.

Methods and analysis

We will conduct a pilot feasibility, single-blinded, randomised controlled trial comparing the EIP with standard care across two study sites (one urban, one rural) in central Uganda. Eligible infants (n=126, age 6–11 completed months) with neurodevelopmental impairment (defined as a developmental quotient

Ethics and dissemination

The trial protocol has been approved by the relevant Ugandan and UK ethics committees. Recruited families will give written informed consent and we will follow international codes for ethics and good clinical practice. Dissemination will be through peer-reviewed publications, conference presentations and public engagement.

Trial registration number

ISRCTN44380971; protocol version 3.0, 19th February 2018.

Jandu Yani U 'For All Families Triple P--positive parenting program in remote Australian Aboriginal communities: a study protocol for a community intervention trial

Por: Andersson · E. · McIlduff · C. · Turner · K. · Thomas · S. · Davies · J. · Elliott · E. J. · Einfeld · S.
Introduction

The population-based (Lililwan) study of fetal alcohol spectrum disorder (FASD) revealed a high prevalence of FASD in the remote communities of the Fitzroy Valley, Western Australia (WA) and confirmed anecdotal reports from families and teachers that challenging child behaviours were a significant concern. In response, Marninwarntikura Women’s Resource Centre initiated a partnership with researchers from The University of Sydney to bring the positive parenting program (Triple P) to the Valley. Triple P has been effective in increasing parenting skills and confidence, and improving child behaviour in various Indigenous communities.

Methods and analysis

Extensive consultation with community leaders, service providers, Aboriginal health networks and academic institutions was undertaken and is ongoing. Based on community consultations, the intervention was adapted to acknowledge local cultural, social and language complexities. Carers of children born after 1 January 2002 and living in the Fitzroy Valley are invited to participate in Group Triple P, including additional Stepping Stones strategies for children with complex needs. Programme are delivered by local community service workers, trained and accredited as Triple P providers or ‘parent coaches’. Assessments for parent coach pretraining and post-training includes their perceived ability to deliver the intervention and the cultural appropriateness of the programme. Carers complete preintervention and postintervention and 6-month follow-up assessments of parenting practices, self-efficacy and child behaviour.

Ethics and dissemination

Approval was granted by the University of Sydney Human Ethics Committee, WA Aboriginal Health Ethics Committee, WA Country Health Services Ethics Committee and Kimberley Aboriginal Health Planning Forum. Consultation with community is imperative for efficacy, engagement, community ownership and sustainability of the programme, and will be ongoing until findings are disseminated. Anonymous findings will be disseminated through peer-reviewed journals, community feedback sessions and scientific forums.

Association between quantitative sensory testing and pain or disability in paediatric chronic pain: protocol for a systematic review and meta-analysis

Por: Schoth · D. E. · Blankenburg · M. · Wager · J. · Broadbent · P. · Zhang · J. · Zernikow · B. · Liossi · C.
Introduction

This protocol describes the objective and methods of a systematic review of the association between quantitative sensory testing (QST) measures and pain intensity or disability in paediatric chronic pain (PCP). The review will also assess whether the relationship strength is moderated by variables related to the QST method and pain condition; the use of QST in PCP (modalities, outcome measures and anatomical test sites as well as differentiating between pain mechanisms (eg, neuropathic vs nociceptive) and in selecting analgesics); the reliability of QST across the paediatric age range; the ability of QST to differentiate patients with chronic pain from healthy controls; and differences between anatomical test sites.

Methods and analysis

Medline, PsycINFO, CINHAL, Web of Science, Scopus, Cochrane Library and OpenGrey will be searched. English language studies will be eligible if they recruit a sample aged 6–24 (inclusive) with chronic pain, including primary and secondary pain; apply at least one of the following QST modalities: chemical, electrical, mechanical (subgroups include pressure, punctate/brush and vibratory) or thermal stimulus to measure perception of noxious or innocuous stimuli applied to skin, muscle or joint; use a testing protocol to control for stimulus properties: modality, anatomical site, intensity, duration and sequence. Following title and abstract screening, the full texts of relevant records will be independently assessed by two reviewers. For eligible studies, one reviewer will extract study characteristics and data, and another will check for accuracy. Both will undertake independent quality assessments using the Appraisal Tool for Cross-Sectional Studies. A qualitative synthesis will be presented with discussion centred around different QST modalities. Where eligible data permit, meta-analyses will be performed separately for different QST modalities using comprehensive meta-analysis.

Ethics and dissemination

Review findings will be reported in a peer-reviewed journal and presented at conferences. The study raises no ethical issues.

PROSPERO registration number

CRD42019134069.

Understanding autism spectrum disorder and social functioning in children with neurofibromatosis type 1: protocol for a cross-sectional multimodal study

Por: Haebich · K. M. · Pride · N. A. · Walsh · K. S. · Chisholm · A. · Rouel · M. · Maier · A. · Anderson · V. · Barton · B. · Silk · T. · Korgaonkar · M. · Seal · M. · Lami · F. · Lorenzo · J. · Williams · K. · Dabscheck · G. · Rae · C. D. · Kean · M. · North · K. N. · Payne · J. M.
Introduction

Children with the single-gene disorder neurofibromatosis type 1 (NF1) appear to be at an increased risk for autism spectrum disorder (ASD) and exhibit a unique social-cognitive phenotype compared with children with idiopathic ASD. A complete framework is required to better understand autism in NF1, from neurobiological levels through to behavioural and functional outcomes. The primary aims of this study are to establish the frequency of ASD in children with NF1, examine the social cognitive phenotype, investigate the neuropsychological processes contributing to ASD symptoms and poor social functioning in children with NF1, and to investigate novel structural and functional neurobiological markers of ASD and social dysfunction in NF1. The secondary aim of this study is to compare the neuropsychological and neurobiological features of ASD in children with NF1 to a matched group of patients with idiopathic ASD.

Methods and analysis

This is an international, multisite, prospective, cross-sectional cohort study of children with NF1, idiopathic ASD and typically developing (TD) controls. Participants will be 200 children with NF1 (3–15 years of age), 70 TD participants (3–15 years) and 35 children with idiopathic ASD (7–15 years). Idiopathic ASD and NF1 cases will be matched on age, sex and intelligence. All participants will complete cognitive testing and parents will rate their child’s behaviour on standardised questionnaires. Neuroimaging will be completed by a subset of participants aged 7 years and older. Children with NF1 that screen at risk for ASD on the parent-rated Social Responsiveness Scale 2nd Edition will be invited back to complete the Autism Diagnostic Observation Scale 2nd Edition and Autism Diagnostic Interview-Revised to determine whether they fulfil ASD diagnostic criteria.

Ethics and dissemination

This study has hospital ethics approval and the results will be disseminated through peer-reviewed publications and international conferences.

The WHEAT pilot trial--WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial

Por: Gale · C. · Modi · N. · Jawad · S. · Culshaw · L. · Dorling · J. · Bowler · U. · Forster · A. · King · A. · McLeish · J. · Linsell · L. · Turner · M. A. · Robberts · H. · Stanbury · K. · van Staa · T. · Juszczak · E.
Introduction

Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment.

Methods and analysis

We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at

Ethics and dissemination

This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will inform future EPR-embedded and data-enabled trials and will be disseminated through conferences, publications and parent-centred information.

Trial registration number

ISRCTN registry ISRCTN62501859; Pre-results.

Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial

Por: Romanska · J. · Margas · W. · Bokiniec · R. · Krajewski · P. · Seliga-Siwecka · J.
Introduction

Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants.

Methods and analysis

Very low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks’ postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of –210 g.

Ethics and dissemination

The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences.

Trial registration number

NCT03730883.

Protocol version

Version 3. 14.08.2019.

Relationship between breast feeding and motor development in children: protocol for a systematic review and meta-analysis

Introduction

The recommendations of most health organisations encourage mothers to keep exclusive breast feeding during the first 6 months and combining breast feeding with complementary feeding at least during the first and second years, due to the numerous immunologic, cognitive developmental and motor skill benefits that breast feeding confers. Although the influence of breast feeding on motor development during childhood has been studied, the findings are inconsistent, and some studies have even reported no effect. This manuscript presents a protocol for a systematic review and meta-analysis, with the aim of reviewing the relationship between breast feeding and motor skill development in children in terms of duration, exclusivity or non-exclusivity of breast feeding.

Methods and analysis

The search will be conducted using Medline (via PubMed), EMBASE, Web of Science and Cochrane Library from inception to December 2019. Observational studies (cross-sectional and follow-up studies) written in English or Spanish that investigate the association between breast feeding and motor development in children will be included. This systematic review and meta-analysis protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. The Critical Appraisal Checklist for Analytical Cross-Sectional Studies and The Newcastle-Ottawa Quality Assessment Scale for longitudinal studies will be used to assess the quality of included studies. The effect of breast feeding on motor skill development will be calculated as the primary outcome. Subgroup analyses will be carried out based on the characteristics of motor skill development and the population included.

Ethics and dissemination

Ethical approval is not required because the data used will be obtained from published studies, and there will be no concerns about privacy. The findings from this study will be relevant information regarding the association of breast feeding with motor development in children and could be used encourage to improve breastfeeding rates. The results will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42018093706.

Perspective of asylum-seeking caregivers on the quality of care provided by a Swiss paediatric hospital: a qualitative study

Por: Brandenberger · J. · Sontag · K. · Duchene-Lacroix · C. · Jaeger · F. N. · Peterhans · B. · Ritz · N.
Objectives

This study investigated the perspective of asylum-seeking caregivers on the quality of healthcare delivered to their children in a qualitative in-depth interview study. The health of asylum-seeking children is of key interest for healthcare providers, yet knowledge of the perspective of asylum-seeking caregivers when accessing healthcare is limited.

Setting

The study took place in a paediatric tertiary care hospital in Basel, Switzerland.

Participants

Interviews were done with 13 asylum-seeking caregivers who had presented with their children at the paediatric tertiary care hospital. Nine female and four male caregivers from Tibet, Eritrea, Afghanistan, Syria, Iraq, Albania and Macedonia were included. A diverse sample was chosen regarding cultural and social background, years of residence in Switzerland and reasons for seeking care. A previously developed and pilot-tested interview guide was used for semistructured in-depth interviews between 36 and 92 min in duration. Data analysis and reporting was done according to Consolidated Criteria for Reporting Qualitative Research. The number of interviews was determined by saturation of data.

Results

The interviewees described a mismatch of personal competencies and external challenges. Communication barriers and unfamiliarity with new health concepts were reported as challenges. These were aggravated by isolation and concerns about their child’s health. The following factors were reported to strongly contribute to satisfaction of healthcare delivery: a respectful and trusting caregiver–provider relationship, the presence of interpreters and immediate availability of treatment.

Conclusions

A mismatch of personal competencies and external challenges importantly influences the caregiver–provider relationship. To overcome this mismatch establishment of confidence was identified as a key factor. This can be achieved by availability of interpreter services, sufficient consultation time and transcultural trainings for healthcare workers. Coordination between the family, the government’s asylum system and the medical system is required to facilitate this process.

Protocol for a multisite randomised trial of Hand-Arm Bimanual Intensive Training Including Lower Extremity training for children with bilateral cerebral palsy: HABIT-ILE Australia

Por: Sakzewski · L. · Bleyenheuft · Y. · Boyd · R. N. · Novak · I. · Elliott · C. · Reedman · S. · Morgan · C. · Pannek · K. · Fripp · J. · Golland · P. · Rowell · D. · Chatfield · M. · Ware · R. S.
Introduction

Children with bilateral cerebral palsy often experience difficulties with posture, gross motor function and manual ability, impacting independence in daily life activities, participation and quality of life (QOL). Hand–Arm Bimanual Intensive Training Including Lower Extremity (HABIT-ILE) is a novel intensive motor intervention integrating upper and lower extremity training. This study aimed to compare HABIT-ILE to usual care in a large randomised controlled trial (RCT) in terms of gross motor function, manual ability, goal attainment, walking endurance, mobility, self-care and QOL. A within-trial cost–utility analysis will be conducted to synthesise costs and benefits of HABIT-ILE compared with usual care.

Methods and analysis

126 children with bilateral cerebral palsy aged 6–16 years will be recruited across three sites in Australia. Children will be stratified by site and Gross Motor Function Classification System and randomised using concealed allocation to either receiving HABIT-ILE immediately or being waitlisted for 26 weeks. HABIT-ILE will be delivered in groups of 8–12 children, for 6.5 hours per day for 10 days (total 65 hours, 2 weeks). Outcomes will be assessed at baseline, immediately following intervention, and then retention of effects will be tested at 26 weeks. Primary outcomes will be the Gross Motor Function Measure and ABILHAND-Kids. Secondary outcomes will be brain structural integrity, walking endurance, bimanual hand performance, self-care, mobility, performance and satisfaction with individualised goals, and QOL. Analyses will follow standard principles for RCTs using two-group comparisons on all participants on an intention-to-treat basis. Comparisons between groups for primary and secondary outcomes will be conducted using regression models.

Ethics and dissemination

Ethics approval has been granted by the Medical Research Ethics Committee of Children’s Health Queensland Hospital and the Health Service Human Research Ethics Committee (HREC/17/QRCH/282) of The University of Queensland (2018000017/HREC/17/QRCH/2820), and The Cerebral Palsy Alliance Ethics Committee (2018_04_01/HREC/17/QRCH/282).

Trial registration number

ACTRN12618000164291.

Cohort profile: the Canadian coordination and activity tracking in children (CATCH) longitudinal cohort

Por: Cairney · J. · Veldhuizen · S. · Rodriguez · M. C. · King-Dowling · S. · Kwan · M. Y. · Wade · T. · Price · D. · Missiuna · C. · Timmons · B.
Purpose

Developmental coordination disorder (DCD) is a prevalent, neurodevelopmental disorder affecting 2% to 5% of children, which is characterised by fine and gross motor problems. Children with DCD have been shown to be less fit and physically active than other children; however, the direction of causality is unknown as previous studies have typically been done in older children when the differences in fitness and physical activity are already present. The aim of the Coordination and Activity Tracking in Children (CATCH) study is to specifically address the issue of precedence by recruiting a large sample of children in early childhood.

Participants

CATCH comprises a community-based sample of parents and children 4 to 5 years of age divided into two groups: at risk for DCD (rDCD; n=287) and typically developing (TD; n=301). Inclusion in the rDCD group required a score at or below the 16th percentile on a standardised test of motor coordination and a score above 70 on a standardised test of intelligence.

Findings to date

Children in the rDCD group contained a higher proportion of males (67% vs 48%, 2=21.9, p2=7.4, p=0.004). According to parent report, rDCD children experienced more problems in self-care, school and leisure activities (p

Future plans

Children are being followed up annually for 3 years. At each follow-up, motor coordination testing is repeated, and data are collected on physical activity, fitness and social-emotional problems.

Exploring healthcare providers perspectives of the paediatric discharge process in Uganda: a qualitative exploratory study

Por: Nemetchek · B. · Khowaja · A. · Kavuma · A. · Kabajaasi · O. · Olirus Owilli · A. · Ansermino · J. M. · Fowler-Kerry · S. · Jacob · S. T. · Kenya-Mugisha · N. · Kabakyenga · J. · Wiens · M. O.
Introduction

The burden of childhood mortality continues to be born largely by low-income and middle-income countries. The critical postdischarge period has been largely neglected despite evidence that mortality rates during this period can exceed inpatient mortality rates. However, there is a paucity of data on the paediatric discharge process from the perspective of the healthcare provider. Provider perspectives may be important in the development of an improved understanding of the barriers and facilitators to improving the transition from hospital to home.

Objectives

To explore healthcare providers’ and facility administrators’ perspectives of the paediatric discharge process with respect to: (1) current procedures, (2) barriers and challenges, (3) ideas for change, (4) facilitators for change and (5) the importance of discharge planning.

Design

A qualitative exploratory approach using focus groups (14) and in-depth interviews (7).

Setting

This study was conducted at seven hospitals providing paediatric care in Uganda.

Results

Current discharge procedures are largely based on hospital-specific protocols or clinician opinion, as opposed to national guidelines. Some key barriers to an improved discharge process included caregiver resources and education, critical communication gaps, traditional practices, and a lack of human and physical resources. Teamwork and motivation to see improved paediatric transitions to home were identified as facilitators to implementing the ideas for change proposed by participants. The need for a standardised national policy guiding paediatric discharges, implemented through education at many levels and coupled with appropriate community referral and follow-up, was broadly perceived as essential to improving outcomes for children.

Conclusions

Although significant challenges and gaps were identified within the current health system, participants’ ideas and the identified facilitators provide a significant basis from which change may occur. This work can facilitate the development of sustainable and effective interventions to improve postdischarge outcomes in Uganda and other similar settings.

Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial

Por: Sie · A. · Bountogo · M. · Nebie · E. · Ouattara · M. · Coulibaly · B. · Bagagnan · C. · Zabre · P. · Lebas · E. · Brogdon · J. · Godwin · W. W. · Lin · Y. · Porco · T. · Doan · T. · Lietman · T. M. · Oldenburg · C. E. · NAITRE Study Group · Sie · Bountogo · Ouattara · Coulibaly · Bagagna
Introduction

Biannual mass azithromycin distribution to children aged 1–59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.

Methods and analysis

The Nouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants (NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8–27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.

Ethics and dissemination

This study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d’Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.

Trial registration number

NCT03682653; Pre-results.

Choosing Healthy Eating for Infant Health (CHErIsH) study: protocol for a feasibility study

Por: Matvienko-Sikar · K. · Toomey · E. · Queally · M. · Flannery · C. · O Neill · K. · Dinan · T. G. · Doherty · E. · Harrington · J. M. · Hayes · C. · Heary · C. · Hennessy · M. · Kelly · C. · Mc Hugh · S. M. · McSharry · J. · Stanton · C. · Heffernan · T. · Byrne · M. · Kearney · P. M.
Introduction

Childhood obesity is a public health challenge. There is evidence for associations between parents’ feeding behaviours and childhood obesity risk. Primary care provides a unique opportunity for delivery of infant feeding interventions for childhood obesity prevention. Implementation strategies are needed to support infant feeding intervention delivery. The Choosing Healthy Eating for Infant Health (CHErIsH) intervention is a complex infant feeding intervention delivered at infant vaccination visits, alongside a healthcare professional (HCP)-level implementation strategy to support delivery.

Methods and analysis

This protocol provides a description of a non-randomised feasibility study of an infant feeding intervention and implementation strategy, with an embedded process evaluation and economic evaluation. Intervention participants will be parents of infants aged ≤6 weeks at recruitment, attending a participating HCP in a primary care practice. The intervention will be delivered at the infant’s 2, 4, 6, 12 and 13 month vaccination visits and involves brief verbal infant feeding messages and additional resources, including a leaflet, magnet, infant bib and sign-posting to an information website. The implementation strategy encompasses a local opinion leader, HCP training delivered prior to intervention delivery, electronic delivery prompts and additional resources, including a training manual, poster and support from the research team. An embedded mixed-methods process evaluation will examine the acceptability and feasibility of the intervention, the implementation strategy and study processes including data collection. Qualitative interviews will explore parent and HCP experiences and perspectives of delivery and receipt of the intervention and implementation strategy. Self-report surveys will examine fidelity of delivery and receipt, and acceptability, suitability and comprehensiveness of the intervention, implementation strategy and study processes. Data from electronic delivery prompts will also be collected to examine implementation of the intervention. A cost–outcome description will be conducted to measure costs of the intervention and the implementation strategy.

Ethics and dissemination

This study received approval from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Study findings will be disseminated via peer-reviewed publications and conference presentations.

Implementation of the Dutch expertise centre for child abuse: descriptive data from the first 4 years

Objective

Combined paediatric and forensic medical expertise to interpret physical findings is not available in Dutch healthcare facilities. The Dutch Expertise Centre for Child Abuse (DECCA) was founded in the conviction that this combination is essential in assessing potential physical child abuse. DECCA is a collaboration between the three paediatric hospitals and the Netherlands Forensic Institute. DECCA works with Bayes’ theorem and uses likelihood ratios in their conclusions.

Design

We present the implementation process of DECCA and cross-sectional data of the first 4 years.

Participants

Between 14 December 2014 and 31 December 2018, a total of 761 advisory requests were referred, all of which were included in this study. An advisee evaluation over the year 2015 was performed using a self-constructed survey to gain insight in the first experiences with DECCA.

Results

761 cases were included, 381 (50.1%) boys and 361 (47.4%) girls (19 cases (2.5%) sex undisclosed). Median age was 1.5 years (range 1 day to 20 years). Paediatricians (53.1%) and child safeguarding doctors (21.9%) most frequently contacted DECCA. The two most common reasons for referral were presence of injury/skin lesions (n=592) and clinical history inconsistent with findings (n=145). The most common injuries were bruises (264) and non-skull fractures (166). Outcome of DECCA evaluation was almost certainly no or improbable child abuse in 35.7%; child abuse likely or almost certain in 24.3%, and unclear in 12%. The advisee evaluations (response rate 50%) showed that 93% experienced added value and that 100% were (very) satisfied with the advice.

Conclusion

Data show growing interest in the expertise of DECCA through the years. DECCA seems to be a valuable addition to Dutch child protection, since advisee value the service and outcome of DECCA evaluations. In almost half of the cases, DECCA concluded that child abuse could not be substantiated.

Identification of risk factors affecting catch-up growth after infant congenital heart disease surgery: rationale and design of a multicentre prospective cohort study in China

Por: Li · L. · LI · K. · An · C. · Fan · J. · Guo · C. · Liang · S. · Guo · Y. · Xia · H. · Chen · X. · Zhu · Y. · Hu · C. · Si · W. · Liang · H. · Cui · Y.
Introduction

Successful surgical treatment of congenital heart disease improves neonates’ long-term survival and leads to catch-up growth, which however does not occur in part of the patient population for largely undetermined reasons.

Methods and analysis

A multicentre, prospective cohort study is being conducted in four paediatric medical institutions in China to collect detailed nutritional, anthropometric and clinical data at perioperative phases and during a 1-year period of follow-up after surgery. The study is expected to recruit approximately 5000 patients by the year of 2023 when the cohort is fully established. The primary endpoint of this study is the occurrence of postoperative catch-up growth, which will be determined in both absolute and relative terms (ie, reduced anthropometric deficits from the reference measures and improved z-scores that have passed the –2 SD cut-offs). Multivariable regression analyses will be performed to identify factors that are statistically significantly associated with the absence of postoperative catch-up growth.

Ethics and dissemination

The protocol of this study has been approved by the individual ethics committees of the participating centres (Guangzhou Women and Children’s Medical Centre (2008071601), the Children’s Hospital of Zhejiang University School of Medicine (2018-IRB-094), Gansu Provincial Maternity and Child-Care Hospital (2019-IRB-01) and Zhengzhou Cardiovascular Hospital (2019012001)). Written informed consent from parents will be obtained before study entry. Findings of this study will be disseminated through publications in international peer-reviewed journals and will be presented in academic conferences.

Responsive Asthma Care for Teens (ReACT): development protocol for an adaptive mobile health intervention for adolescents with asthma

Por: Cushing · C. C. · Fedele · D. A. · Patton · S. R. · McQuaid · E. L. · Smyth · J. M. · Prabhakaran · S. · Gierer · S. · Koskela-Staples · N. · Ortega · A. · Fleming · K. K. · Nezu · A. M.
Introduction

Asthma is a leading cause of youth morbidity in the USA, affecting >8% of youth. Adherence to inhaled corticosteroids (ICS) can prevent asthma-related morbidity; however, the typical adolescent with asthma takes fewer than 50% of their prescribed doses. Adolescents are uniquely vulnerable to suboptimal asthma self-management due to still-developing executive functioning capabilities that may impede consistent self-regulation and weaken attempts to use problem solving to overcome barriers to ICS adherence.

Methods and analysis

The aims of this project are to improve adherence to ICS as an important step towards better self-management among adolescents aged 13–17 years diagnosed with asthma by merging the efficacious behaviour change strategies found in behavioural health interventions with scalable, adaptive mobile health (mHealth) technologies to create the Responsive Asthma Care for Teens programme (ReACT). ReACT intervention content will be developed through an iterative user-centred design process that includes conducting (1) one-on-one interviews with 20 teens with asthma; (2) crowdsourced feedback from a nationally representative panel of 100 adolescents with asthma and (3) an advisory board of youth with asthma, a paediatric pulmonologist and a behavioural health expert. In tandem, we will work with an existing technology vendor to programme ReACT algorithms to allow for tailored intervention delivery. We will conduct usability testing of an alpha version of ReACT with a sample of 20 target users to assess acceptability and usability of our mHealth intervention. Participants will complete a 4-week run-in period to monitor their adherence with all ReACT features turned off. Subsequently, participants will complete a 4-week intervention period with all ReACT features activated. The study started in October 2018 and is scheduled to conclude in late 2019.

Ethics and dissemination

Institutional review board approval was obtained at the University of Kansas and the University of Florida. We will submit study findings for presentation at national research conferences that are well attended by a mix of psychologists, allied health professionals and physicians. We will publish study findings in peer-reviewed journals read by members of the psychology, nursing and pulmonary communities.

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