Intrauterine growth restriction (IUGR) is a pregnancy condition, which is associated with poor perinatal outcomes and long-term neurodevelopmental impairment. Several studies also investigated the impact of IUGR on child behaviour (eg, internalising and externalising behaviour, social competencies). However, so far, no systematic review or meta-analysis has been conducted that summarises these effects while considering relevant third variables such as type of IUGR diagnosis and control group, or concurrent cognitive abilities. The objective of this study is to summarise the current evidence regarding the relationship between IUGR and behavioural outcomes from early childhood to young adulthood. Additionally, to explore how third variables such as type of control group, or cognitive abilities, relate to this association.

Search strategy: The following electronic databases will be searched—Web of Science, Medline Ovid, PsycInfo, Cochrane Library, Scopus and Embase. Inclusion criteria: observational (eg, cohort studies and case–control studies) and intervention studies (if standard care is used and norm values are reported for the control group) will be included if they quantitatively compare children with and without IUGR from the age of 2 to 18 years. The main outcomes are internalising and externalising behaviour, and social competencies.

No ethics approval was necessary for this protocol. Dissemination of findings will be done by publishing the results in peer-reviewed journals. The results of this systematic review will provide guidance for practice and counselling for clinicians and therapists facing patients affected by IUGR and their families.

CRD42022347467.

Children with congenital heart disease (CHD) are at risk for executive functions (EF) impairments. To date, interventions have limited effects on EF in children and adolescents with complex CHD. Therefore, we developed a new multimodal and personalised EF intervention (E-Fit). This study aims to test the feasibility of this intervention called ‘E-Fit’ for children with complex CHD and EF impairments.

This is a single-centre, single-blinded, randomised controlled feasibility study exploring the E-Fit intervention. We aim to enrol 40 children with CHD aged 10–12 years who underwent infant cardiopulmonary bypass surgery and show clinically relevant EF impairments (T-score ≥60 on any Behaviour Rating Inventory for Executive Function questionnaire summary scale). The multimodal intervention was developed with focus groups and the Delphi method involving children and adolescents with CHD, their parents and teachers, and health professionals. The intervention is composed of three elements: computer-based EF training using CogniFit Inc 2022, performed three times a week at home; weekly EF remote strategy coaching and analogue games. The content of the computer and strategy training is personalised to the child’s EF difficulties. The control group follows their daily routines as before and completes a diary about their everyday activities four times a week. Participants will be randomised in a 1:1 ratio. Feasibility is measured by the participants’ and providers’ ratings of the participants’ adherence and exposure to the intervention, recruitment rates and the evaluation of the intended effects of the programme.

Local ethics committee approval was obtained for the study (BASEC-Nr: 2021-02413). Parents provide written informed consent. Key outputs from the trial will be disseminated through presentations at conferences, peer-reviewed publications and directly to participating families. Furthermore, these results will inform the decision whether to proceed to a randomised controlled trial to investigate effectiveness.

NCT05198583.

To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.

Phase 3b multicentre, double-blind, randomised placebo-controlled trial.

Twenty-one hospitals in the UK.

Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.

Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.

The primary outcome was a ‘good recovery’ at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended.

The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.

18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.

The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis.

Clinical Trials.gov NCT02308982; ICRCTN registry ISRCTN15791925.

Hypocalcaemia forms part of the ‘diamond of death’ in major trauma, alongside hypothermia, acidosis and coagulopathy. In adults, admission hypocalcaemia prior to transfusion is associated with increased mortality, increased blood transfusion requirements and coagulopathy. Data on paediatric major trauma patients are limited. This systematic review and meta-analysis aims to describe and synthesise the available evidence relevant to paediatric trauma, admission hypocalcaemia and outcome.

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. A planned literature search for articles in the English language will be conducted from inception to the date of searches using MEDLINE on the EBSCO platform, CINAHL on the EBSCO platform and Embase on the Ovid platform. The grey literature will also be searched. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. Heterogeneity will be assessed using the I² test, and the risk of bias will be assessed using the ROBINS-I tool. A meta-analysis will be undertaken using ratio measures (OR) and mean differences for measures of effect. When possible, the estimate of effect will be presented along with a CI and a p value.

Ethical review is not required, as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.

CRD42023425172.

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

Our aim was to investigate the association between early environmental factors and the development of coeliac disease (CeD) in adolescents, recruited from a cohort nested in the Danish National Birth Cohort (DNBC).

The study was designed as a prospective cohort study, nested in DNBC

The Glutenfunen cohort comprises 1266 participants, nested in DNBC. All participants were screened for CeD, and in total, 28 cases of biopsy proven CeD were identified. Data about breastfeeding, timing of introduction to solid food in infancy, use of antibiotics, infections and symptoms were parentally reported prospectively at 6 months and 18 months, respectively. We estimated ORs and 95% CIs of CeD in adolescents using logistic regression analysis.

Viral croup reported at 18 months of age was associated with CeD in adolescents with an OR of 3.2 (95% CI: 1.2 to 8.7). Furthermore, otitis media also reported at 18 months of age was linked with CeD with an OR of 3.2 (95% CI: 1.5 to 7.3). We were not able to find any statistical associations between CeD and breastfeeding, frequency of infections, parentally reported use of antibiotic and timing of solid foods.

In this study, we present an overview of the relationship between early environmental factors and occurrence of CeD in adolescents. Our findings, despite limitations due to a limited number of cases of CeD, suggest a role of viral infections in the pathogenesis of CeD

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus. Being a common reason for hospitalisation, it affects 13–17% of all hospitalised children younger than 2 years. Only supportive therapy, including suctioning nasal secretions, water–electrolyte balance maintenance and oxygen supplementation when needed, is recommended. However, non-evidence-based diagnostic and therapeutic approaches, including the use of inhaled bronchodilators, nebulised epinephrine, and nebulised and systemic steroids, are common. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. We aim to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.

This will be a randomised, double-blinded, parallel-group, controlled trial. Children younger than 2 years who are hospitalised due to bronchiolitis will be recruited from at least three paediatric departments in Poland. Bronchiolitis is defined as an apparent viral respiratory tract infection associated with airway obstruction that is manifested by at least one of following symptoms: tachypnoea, increased respiratory effort, crackles and/or wheezing. A total of 140 children will be randomised (1:1) to receive either hypertonic saline nebulisation (5 mL, three times a day) or normal saline at the same dose. The primary outcome measure will be the duration of hospitalisation.

The Bioethics Committee of the Lower Silesia Medical Chamber in Wroclaw approved the study protocol (4/PNDR/2023). Caregivers will receive oral and written information about the study and written informed consent will be obtained by the study physicians. The findings of the study will be submitted to a peer-reviewed journal, and abstracts will be submitted to relevant national and international conferences.

ClinicalTrials.gov Registry (NCT06069336).

To assess the association between birth weight and childhood asthma risk using data from the 2019–2020 National Survey of Children’s Health database.

Cross-sectional study.

The USA.

A representative cohort of American children.

The exposure of this study was birth weight regardless of gestational age. Birth weight was divided into three groups: 2500 g.

Primary outcomes were parent-reported diagnosis of asthma.

The Rao-Scott ² test was used to compare the groups. The main analyses examined the association between birth weight and parent-report asthma in children using univariable and multivariable logistic models adjusting for preterm birth, age, sex, race, family poverty, health insurance, smoking, maternal age. Subgroup analysis was performed based on interaction test.

A total of 60 172 children aged 3–17 years were enrolled in this study; of these, 5202 (~8.6%) had asthma. Children with asthma were more likely to be born preterm, with low birth weight (LBW) or very LBW (VLBW). The incidence of asthma was the highest in VLBW children at 20.9% and showed a downward trend with an increase in birth weight class, with rates of 10.7% and 8.1% in the LBW and normal birthweight groups, respectively. Children with VLBW (OR 1.97; 95% CI 1.29 to 3.01) had higher odds of developing asthma in the adjusted analysis model. However, VLBW was only shown to be a risk factor for asthma among Hispanics, black/African-Americans and children between the ages of 6 and 12 years, demonstrating racial and age disparities.

VLBW increases the risk of childhood asthma; however, racial and age disparities are evident.

While ensuring appropriate growth is essential for all children, optimising nutritional status in children with cystic fibrosis (CF) is critical for improving health outcomes. Nutritional challenges in CF are multifactorial and malnutrition is common. While gastrostomy tubes (G-tubes) can improve weight status in individuals with CF, they also have common and chronic complications resulting in clinical equipoise. To date, factors influencing G-tube decision-making among caregivers of children with CF have not been systematically explored. This review aims to chart existing knowledge about caregivers’ decisional needs related to G-tube placement, with a focus on caregivers of children with CF, as well as known medical and psychosocial benefits and risks of G-tube feedings in paediatric care.

This scoping review will follow the JBI methodological framework. We will include articles published between 1 January 1985 and 1 November 2023 in English and Spanish from MEDLINE (Ovid), Embase, CINAHL, PsycInfo, Cochrane Database of Systematic Reviews and Web of Science related to G-tube decision-making. Articles published in languages besides English and Spanish will be excluded. Articles will be screened for final eligibility and inclusion according to title and abstract, followed by full texts. Articles will be independently reviewed by two reviewers and any disagreements discussed with a third reviewer for consensus. We will map themes and concepts, and data extracted will be presented in tabular, diagrams and descriptive summaries.

As a form of secondary analysis, scoping reviews do not require ethics approval. This review will inform future research with caregivers involved in G-tube decision-making for children with CF. The final review will be submitted to a peer-reviewed scientific journal, disseminated at relevant academic conferences and will be shared with patients and clinicians.

Center for Open Science. https://osf.io/g4pdb.

Conservative treatment for adolescent idiopathic scoliosis (AIS) using bracing has proven to be effective at reducing curve progression. However, variation in brace design and lack of brace specificity hamper clinical treatment outcomes as well as the predictability and comparison hereof. To overcome this, recent technological developments aim to generate transparent and objective criteria for brace manufacturing by applying computer-aided design software and additive manufacturing to produce braces for scoliosis treatment. Yet, the extent of its applicability and clinical implementation are to be determined. This study will identify and map the available evidence for the methodology and application of three-dimensional technology for the design and production of clinical braces used for treatment in patients with AIS.

This scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. This scoping review will consider studies on methodology of three-dimensional technological methodology and applications that have been or are currently being applied in brace treatment of AIS. The following databases will be searched: MEDLINE, Web of Science, Cochrane Database of Systematic Reviews and Embase (OVID). Search limits will be applied; for example, only articles written in the English language published after 2000 will be included. The retrieved articles will be screened independently by two researchers. A third researcher will be consulted in case of disagreement. Data from relevant articles will be independently extracted by two researchers and presented in a tabular manner accompanied by a descriptive narration.

Considering the nature of the study, no ethical approval needed to be requested. The study result will be submitted to a peer-reviewed journal.

This cross-sectional comparative study aimed to analyse and compare the story-grammar components in Tamil-speaking children with and without hearing impairment (HI) narratives.

The study used a cross-sectional, comparative design to assess and compare narrative structures.

Data were collected at the Sri Ramachandra Institute of Higher Education and Research in Chennai, India.

30 children participated in the study, including 15 children with severe to profound hearing loss who used cochlear implants and 15 with normal hearing. The participants were language-age-matched children aged 3–5 years, proficient in Tamil.

No specific interventions were implemented in this study.

The primary outcome measures focused on story-grammar components, including settings, characters, initiating events, internal plans, attempts, outcomes, and resolution. These components were evaluated through narrative retellings by the children.

Analysis of the narratives revealed significant differences between the two groups. Children with normal hearing demonstrated a higher representation of story-grammar elements than children with HI.

The findings suggest that children with normal hearing exhibit a more proficient understanding and utilisation of story structure in their story-telling than children with HI. This study highlights the importance of narrative analysis in language assessment, particularly for children with HI. Tailored interventions incorporating appropriate language stimulation techniques are needed to enhance children’s narrative skills with HI. Further research in this area is warranted.

Attention deficit hyperactivity disorder (ADHD) affects 5%–10% of paediatric population and is reportedly more common in children with type 1 diabetes (T1D), exacerbating its clinical course. Proper treatment of ADHD in such patients may thus provide neurological and metabolic benefits. To test this, we designed a non-commercial second phase clinical trial comparing the impact of different pharmacological interventions for ADHD in children with T1D.

This is a multicentre, randomised, open-label, cross-over clinical trial in children and adolescents with ADHD and T1D. The trial will be conducted in four reference paediatric diabetes centres in Poland. Over 36 months, eligible patients with both T1D and ADHD (aged 8–16.5 years, T1D duration >1 year) will be offered participation. Patients’ guardians will undergo online once-weekly training sessions behaviour management for 10 weeks. Afterward, children will be randomised to methylphenidate (long-release capsule, doses 18-36-54 mg) versus lisdexamphetamine (LDX, 30-50-70 mg). Pharmacotherapy will continue for 6 months before switching to alternative medication. Throughout the trial, the participants will be evaluated every 3 months by their diabetologist and online psychological assessments. The primary endpoint (ADHD symptom severity, Conners 3.0 questionnaire) will be assessed by a blinded investigator. Secondary endpoints will include HbA1c, continuous glucose monitoring indices and quality-of-life (PedsQL).

The trial is approved by Bioethical Committee at Medical University of Lodz and Polish regulatory agency (RNN/142/22/KE, UR/DBL/D/263/2022). The results will be communicated to the research and clinical community, and Polish agencies responsible for healthcare policy. Patient organisations focused on paediatric T1D will be notified by a consortium member. We hope to use the trial’s results to promote collaboration between mental health professionals and diabetes teams, evaluate the economic feasibility of using LDX in patients with both diseases and the long run improve ADHD treatment in children with T1D.

EU Clinical Trials Register (EU-CTR, 2022-001906-24) and NCT05957055.

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

Paediatric myocarditis, a rare inflammatory disease, often presents without clear early symptoms. Although cardiac troponin I levels can aid in diagnosing myocarditis, they are not definitive indicators. Troponin I levels frequently fluctuate within and outside the reference range, potentially causing misinterpretations by clinicians. Although a negative troponin I result is valuable for excluding myocarditis, its specificity is low. Moreover, the clinical diagnosis of paediatric myocarditis is exceptionally challenging, and accurate early-stage diagnosis and treatment pose difficulties. Currently, the Dallas criteria, involving cardiac biopsy, serves as the gold standard for myocarditis diagnosis. However, this method has several drawbacks and is unsuitable for children, resulting in its limited use.

In this study, we will employ multiple logistic regression analysis to develop a predictive model for early childhood myocarditis. This model will assess the patient’s condition at onset and provide the probability of a myocarditis diagnosis. Model performance will be evaluated for accuracy and calibration, and the results will be presented through receiver operating characteristic (ROC) curves and calibration plots. Clinical decision curve analysis, in conjunction with ROC curve analysis, will be employed to determine the optimal cut-off value and calculate the net clinical benefit value for assessing clinical effectiveness. Finally, internal model validation will be conducted using bootstrapping.

Approval from the Clinical Research Ethics Committee of The Third Affiliated Hospital of Wenzhou Medical University has been obtained. The research findings will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.

Social prescribing (SP) is a non-medical intervention in which professionals refer patients to a link worker (LW), who connects them with appropriate support. Children and young people (CYP) with neurodisability often have unmet needs and may bypass community initiatives. We undertook a review of hospital-initiated SP for CYP with neurodisability.

Systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance and using Mixed Methods Appraisal Tool.

Medline, PsycINFO, PsycARTICLES, Embase, CINAHL, Scopus, Web of Science and FutureNHS, searched from 1 January 2000 to 19 October 2023, with no language restrictions.

Studies describing SP interventions for CYP (ages 0–25 years) with neurodisability/neurodivergence. Exclusions: interventions outside of secondary care; with no description; or no LW.

Two researchers independently screened references. Data were charted, summarised, quality assessments performed and narratively reviewed.

After removal of duplicates, 518 references were identified. Following screening, eight articles (covering five SP schemes) were included. Rahi et al connected 68 families of CYP newly diagnosed with visual impairment to a community LW. Families needed information about social and educational services, and emotional support. Healthcare professionals had more time for clinical issues. Six papers described three different digital interventions supporting in total 86 CYP with traumatic brain injury and their families. Wade et al (2004, 2005a, 2005b) provided a website with core and individualised sessions, and weekly therapist support. Wade et al (2018) provided a smartphone application, website and weekly meetings with an online coach. These interventions boosted social behaviours. Wade et al (2014, 2015) found that online family problem-solving therapy improved overall child functioning compared with self-guided resources. Toutain et al (2009) provided non-medical support to 11 children with fetal alcohol syndrome and their mothers. No outcome data were provided. Studies reported benefits to health, well-being, healthcare usage, knowledge, skills, satisfaction and service delivery.

Literature describing hospital-initiated SP schemes for CYP with neurodisability, while sparse, suggests potential benefit.

CRD42022384188.

There is an increasing rate of elevated blood pressure, or hypertension, in children and adolescents worldwide, including Sub-Saharan Africa (SSA). Only a few data on adolescent hypertension in SSA, including Sudan, have been published. The aim of the present study was to investigate the prevalence and associated factors of hypertension among adolescent schoolchildren (within the ages of 10 to 19 years) in Sudan.

A cross-sectional school-based study was conducted from June to September 2022.

Six randomly selected schools in Almatamah, River Nile State, Sudan.

Adolescent schoolchildren (within the ages of 10 to 19 years).

Sociodemographic information. Anthropometric and blood pressure measurements were performed in accordance with the standard procedures. An adjusted logistic regression analysis was performed.

Of the 384 enrolled adolescents, 166 (43.2%) and 218 (56.8%) were boys and girls, respectively. The median (IQR) age and body mass index (BMI) were 15.2 years (14.0-16.4 years) and 18.5 kg/m² (16.4-21.5 kg/m²), respectively. Of the 384 adolescents, 240 (62.5%) and 255 (66.4%) had educated mothers and fathers (≥secondary), respectively. 38 adolescents (9.9%) had hypertension (≥95th percentile). The multivariable logistic regression analysis revealed that age, sex and maternal educational level were not associated with hypertension. Paternal educational level according to secondary education attainment (adjusted OR (AOR), 2.72; 95% CI 1.36-5.46) and increasing BMI (AOR, 1.12; 95% CI 1.02-1.20) were associated with hypertension.

1 in 10 adolescents in northern Sudan was hypertensive. Low paternal educational level and increasing BMI were significantly associated with hypertension. The introduction of interventional nutritional programmes at early ages is needed to ensure that adolescents are healthy in their present and later lives. To sustain such programmes, involving all educational parties at early stage is essential.

Recently, with the rapid development of the perinatal medical system and related life-saving techniques, both the short-term and long-term prognoses of extremely preterm infants (EPIs) have improved significantly. In rapidly industrialising countries like China, the survival rates of EPIs have notably increased due to the swift socioeconomic development. However, there is still a reasonably lower positive response towards the treatment of EPIs than we expected, and the current situation of withdrawing care is an urgent task for perinatal medical practitioners.

To develop and validate a model that is practicable for EPIs as soon as possible after birth by regression analysis, to assess the risk of mortality and chance of survival.

This multicentre prospective cohort study used datasets from the Sino-Northern Neonatal Network, including 46 neonatal intensive care units (NICUs). Risk factors including maternal and neonatal variables were collected within 1 hour post-childbirth. The training set consisted of data from 41 NICUs located within the Shandong Province of China, while the validation set included data from 5 NICUs outside Shandong Province. A total of 1363 neonates were included in the study.

Gestational age, birth weight, pH and lactic acid in blood gas analysis within the first hour of birth, moderate-to-severe hypothermia on admission and adequate antenatal corticosteroids were influencing factors for EPIs’ mortality with important predictive ability. The area under the curve values for internal validation of our prediction model and Clinical Risk Index for Babies-II scores were 0.81 and 0.76, and for external validation, 0.80 and 0.51, respectively. Moreover, the Hosmer-Lemeshow test showed that our model has a constant degree of calibration.

There was good predictive accuracy for mortality of EPIs based on influencing factors prenatally and within 1 hour after delivery. Predicting the risk of mortality of EPIs as soon as possible after birth can effectively guide parents to be proactive in treating more EPIs with life-saving value.

ChiCTR1900025234.

Speech problems in patients with a cleft palate are often complex and multifactorial. Finding the optimal way of monitoring these problems is challenging. The International Consortium of Health Outcomes Measurement (ICHOM) has developed a set of standardised outcome measures at specific ages for patients with a cleft lip and/or palate, including measures of speech assessment. This study evaluates the type and timing of speech outcome measures currently included in this ICHOM Standard Set. Additionally, speech assessments in other cleft protocols and initiatives are discussed.

An international, multicentre study was set up including centres from the USA and the Netherlands. Outcomes of clinical measures and Patient Reported Outcome Measures (PROMs) were collected retrospectively according to the ICHOM set. PROM data from a field test of the CLEFT-Q, a questionnaire developed and validated for patients with a cleft, were collected, including participants from countries with all sorts of income statuses, to examine the value of additional moments of measurement that are used in other cleft initiatives.

Data from 2500 patients were included. Measured outcomes contained univariate regression analyses, trend analyses, t-tests, correlations and floor and ceiling effects.

PROMs correlated low to moderate with clinical outcome measures. Clinical outcome measures correlated low to moderate with each other too. In contrast, two CLEFT-Q Scales correlated strongly with each other. All PROMs and the Percent Consonants Correct (PCC) showed an effect of age. In patients with an isolated cleft palate, a ceiling effect was found in the Intelligibility in Context Scale.

Recommendations for an optimal speech outcome assessment in cleft patients are made. Measurement moments of different cleft protocols and initiatives are considered in this proposition. Concerning the type of measures, adjustment of the current PCC score outcome seems appropriate. For centres with adequate resources and specific interest in research, translation and validation of an upcoming tool, the Cleft Audit Protocol for Speech Augmented, is recommended.

Shared decision-making is widely accepted as the best approach for end-of-life decision-making for children with life-limiting conditions. Both paediatricians and parents find benefit in preparing for such decisions. However, little detail is known about this preparatory process. This study aims to explore how paediatricians prepare parents for end-of-life decision-making for a child with a life-limiting condition using clinical simulation.

Individual, semistructured, post-simulation qualitative interviews of paediatricians and parent-actors.

Acute intensive and long-term outpatient paediatric care in Victoria, Australia.

18 purposively sampled paediatricians who treat children with life-limiting conditions and the two parent-actors involved in all simulations. Paediatricians were excluded if they assisted in the study design, worked within specialist palliative care teams or did not provide clinical care outside the neonatal period.

Three key themes in a preparatory process (termed ‘shepherding’) were identified: (1) paediatricians aim to lead parents along a pathway to future end-of-life decisions, (2) paediatricians prefer to control the pace of these discussions and (3) paediatricians recognise they need to have courage to face risk with this preparation. Paediatricians use a variety of shepherding strategies to influence the pace, content and framing of discussions, which may help prepare parents to make the best end-of-life treatment decisions when the time comes.

Shepherding is a newly identified, subtle process intended to influence parents by guiding their understanding of their child’s health and potential suffering in advance of decision-making. Shepherding does not fit within current descriptions of physicians’ decision-making influence. Paced reflection, thinking and provision of information are shepherding strategies preferred by paediatricians, and these appear the same regardless of whether paediatricians intend to steer parents towards particular treatment decisions or simply prepare them for the process of decision-making. Further study about the intention of this influence and parental perception of this communication is needed.

The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.

A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.

Fourteen UK paediatric intensive care units.

Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.

Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child’s participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be ‘streamlined’ to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.

Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.

ISRCTN11746266.