Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m²) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

NCT06457750.

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Ultrasonography is a non-invasive and safe method for assessing muscle morphology. Among its parameters, echo intensity (EI), derived from grayscale image analysis, has emerged as a promising indicator of muscle quality and intramuscular fat infiltration. This study aims to validate EI as a marker for evaluating muscle quality in a population of Czech children, through integration with gold-standard assessments of muscle strength and body composition. The primary aim of this study is to assess the reliability and construct validity of quadriceps muscle EI using ultrasound as a proxy measure of morphological muscle quality in children aged 10–14 years.

Children aged 10–14 years will undergo ultrasound assessment of the quadriceps femoris (QF). EI will be derived from longitudinal scans of each QF head and the cross-sectional area (CSA_QF) from panoramic mid-thigh images. Muscle function will be assessed as maximal voluntary contraction (MVC) of isometric knee extension with muscle quality expressed as MVC/CSA_QF. A 30 s sit-to-stand test (30STS) will be used as an additional functional measure. EI reliability (intra-rater, inter-rater and test–retest) will be evaluated with intraclass correlation coefficients (ICC), Bland–Altman plots and complementary indices. Exploratory known-groups validity will be tested by comparing EI between weight-status groups. Control variables include dual-energy X-ray absorptiometry (DXA)-derived body composition, skeletal age (as determined by DXA hand scans) and physical activity (assessed using 7-day accelerometry).

This study will include 200 children (100 girls and 100 boys) aged 10–14 years using an a priori power analysis based on the primary objective of assessing construct validity through multiple linear regression, assuming an alpha level of 0.05 and 80% power. Participants will be recruited from paediatric outpatients of the Paediatric Obesity Clinic and individuals reached through a recruitment campaign. Inclusion criteria require general good health, while exclusion criteria include a history or symptoms of cardiovascular, pulmonary, metabolic or neurological disease, as well as the use of over-the-counter or prescribed medications. Informed consent and assent will be obtained from all participants.

Reliability of ultrasound-derived EI will be assessed for intra-rater, inter-rater and test–retest agreement using ICC coefficients, Bland–Altman plots and complementary indices such as SE of measurement, coefficient of variation and minimal detectable change at 95% CI, following Consensus-based Standards for the selection of health Measurement Instruments guidelines. Construct validity will be examined by modelling associations between EI and functional muscle quality (MVC/CSA_QF), with 30STS as an additional functional measure. Known-groups validity will be tested by comparing EI across weight groups, using generalised linear regression models adjusted for skeletal age, body composition and physical activity. All validity analyses will be conducted separately for girls and boys. Ultrasound-derived EI of the QF is expected to show high reliability (ICC≥0.80) and acceptable test–retest reproducibility. Construct validity should be supported by moderate associations with functional muscle quality (MVC/CSA_QF), while known-groups validity is expected to reveal higher EI values in children with obesity and/or insufficient physical activity.

The study will be conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (EK 101/2024). Written parental consent and verbal assent from children will be obtained, with all data handled confidentially and anonymised. Results will be disseminated transparently to participants and their families in line with ethical principles of respect, beneficence and justice.

NCT06792279.

We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p

This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.

ChiCTR2500099716.

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Epilepsy ranks as one of the most prevalent neurological disorders, with poorly controlled seizures imposing a significant disease burden. Subclinical epileptiform discharges (SEDs) have been linked to cognitive and behavioural impairments in children. There is a growing trend in clinical practices towards increased use of antiseizure medications (ASMs), as they have the potential to alleviate the impact of SEDs in children. Nonetheless, 25–30% of epilepsy patients do not respond to current antiepileptic treatments. Lacosamide (LCM), a third-generation ASM, has demonstrated established efficacy and tolerability in both adults and children with epilepsy. However, there is a scarcity of studies on LCM as a monotherapy for paediatric patients with epilepsy and SEDs. This study aims to assess the efficacy and safety of LCM monotherapy in epilepsy patients, as well as to examine the impact of LCM on patients with SED.

This prospective cohort study, conducted at a single centre and employing an open-label approach, aims to administer LCM antiepileptic treatment to children while taking into account their seizure profiles, electroencephalogram results, cognitive development and other relevant factors. The index date, marking the administration of the first LCM dose, defines the beginning of the study. The baseline period encompasses the 3 months leading up to the index date, and each child will be monitored until the addition, switch or discontinuation of study drugs, death, completion of a full 1-year follow-up or the conclusion of the study period. Assessments will be conducted every 3 months throughout the follow-up period.

This study received approval from the Ethics Committee of the Children’s Hospital Affiliated with Chongqing Medical University (file number: 2024-210), and all participating sites have obtained the necessary approvals. This study has been registered with the Chinese Clinical Trial Registry. Written informed consent will be sought from the parents or guardians of potential participants under 16 years of age at the outpatient clinic. Additionally, older children with normal cognitive function will be asked to provide their own version of written informed consent. Participation in the study is voluntary, and individuals or their parents/guardians who choose not to provide consent will not be included in the study.

ChiCTR2400092710.

Preterm birth remains a major risk factor for language delay, which may impact learning throughout life. Systematic reviews have shown conflicting effects of maternal voice exposure on premature infants’ physiological parameters, oral feeding and preterm cognitive and neurobehavioural development. Although simple measures to promote language development include exposure to music and maternal voice, the beneficial effects of maternal singing and voice on language and social-emotional development of preterm infants have not been systematically reviewed to confirm these findings. The overall aim of this systematic review is to assess the effects of maternal singing or voice, live or recorded, on the language and social-emotional development of preterm infants compared with standard of care. We will also determine the specific effects of maternal singing or voice on preterm infants’ physiological and behavioural parameters and on maternal stress and mother-infant bonding.

A search strategy will be developed to identify randomised controlled trials published in any language from inception till July 2025 on Medline OVID, EMBASE and CINAHL. We will also search the reference lists of relevant studies and reviews. Two reviewers will independently extract data on study design, baseline characteristics, details of the interventions employed and primary and secondary outcomes using a pre-piloted standardised data extraction form. The risk of bias and quality of evidence assessment will be done independently and in duplicate using the Cochrane Risk of Bias tool and Grading of Recommendations Assessment, Development and Evaluation approach, respectively. Random-effects models will be performed in case meta-analysis is possible, otherwise a qualitative summary will be provided. We will use RevMan 5.1 for data synthesis. We will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Since this is a systematic review or previously published studies, it is exempt from IRB approval and was approved by the school’s Graduate Studies Committee (GSC) studies. The results of this systematic review will be disseminated at relevant conferences and submitted for publication in a peer-reviewed journal.

CRD42024613086.

Paediatric hospitalisation, encompassing the period from admission to discharge, often involves feelings of pain, fear and anxiety, primarily due to clinical diagnoses and, more significantly, discomfort and stress-inducing procedures. Numerous methodologies and interventions have been investigated and implemented to alleviate these phenomena during paediatric hospitalisation. Virtual reality (VR), for example, has demonstrated efficacy in pain relief for hospitalised children in recent studies. This systematic review, therefore, aims to identify and evaluate the effectiveness of VR in alleviating pain, fear and anxiety in hospitalised children undergoing painful procedures.

This systematic review and meta-analysis will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. A systematic search will be conducted in March and April 2025 across the following databases, with no restrictions on language or publication year: PubMed, Embase, Scopus, Web of Science, Cumulated Index in Nursing and Allied Health Literature, ClinicalTrials.gov and the Cochrane Central Register of Controlled Trials. Eligible studies will include randomised and quasi-randomised clinical trials involving children (aged 2–10 years) and adolescents (aged 10–18 years) who received VR interventions during painful procedures. Data will be managed and analysed using Review Manager software (RevMan 5.2.3). In cases of significant heterogeneity (I² > 50%), a random-effects model will be employed to combine studies and calculate the OR with a 95% CI. The methodological quality of the included studies will be assessed using the Cochrane Risk of Bias 2.0 tool, and the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluations framework.

This study will solely review published data; thus, ethical approval is not required. This systematic review is expected to provide subsidies, evidence and insights into the use of VR. It is also anticipated that the results will directly impact the improvement of care for these patients and the qualification of professional care.

CRD42024568297.

Fathers of preterm infants wish to be actively involved and attentive in caring for their children. The positive impacts of paternal caregiving on preterm infants’ cognitive and social development have been recognised. Awareness of the need to support fathers during early parenthood is increasing, but fathers may feel excluded when their infants are in the neonatal intensive care unit. Here, we present the protocol for a study involving the development and national implementation of a complex intervention supporting first-time fathers of preterm infants in early parenthood.

The study adheres to the Medical Research Council framework for complex interventions. A multicentre, prospective, non-blinded, quasi-experimental design will be applied to evaluate the effect of a clinical and technology-based intervention targeting both nurses and the fathers. Outcomes from participants enrolled during the control (2023–2024) and intervention (2025–2026) periods, comprising 295 fathers and their partners, will be compared. Effects on parental confidence, stress, depression and mood and family and reflective functioning as well as infants’ emotional and social development will be assessed. A comprehensive process evaluation will be applied using both qualitative and quantitative methods.

The study has been registered at Clinicaltrials.org [no. NCT0 6 116 747 (The SUPPORTED study – First-time Fathers of Preterm Infants), approved on 3 November 2023]. The Danish Data Protection Agency has approved the study (P-2022–792). The findings will be disseminated through peer-reviewed publications.

NCT06116747.

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

NCT06859632 (ClinicalTrials.gov).

Ages of attainment for early gross motor milestones have been widely studied, but definitions and measurement methods have varied greatly. Since delays in motor milestones have been used extensively as one of the earliest indicators of atypical development, it is imperative to establish a universal understanding of the methods and results reported on motor milestones in typically developing children. Therefore, the primary aim of this scoping review is to provide an overview of recent studies reporting ages of onset for independent sitting and walking in typically developing children worldwide; this will be achieved by summarising how these milestones have been operationalised and evaluated, the samples from whom these data have been drawn, and the reported ages of acquisition.

To meet inclusion criteria, articles must: be original research papers published in any language since 2003, contain a sample of typically developing children and report actual ages of onset for independent sitting and/or walking. To conduct this scoping review, the Joanna Briggs Institute methodological framework will be used. Search terms will include variations of the following concepts: acquisition of motor milestone (independent sitting and/or walking), age of onset, infancy. Six databases (CINAHL Plus, Embase, PsycNet: PsycINFO & PsycArticles, PubMed, Scopus, Web of Science: Core Collection) will be searched. Records from these databases will be screened for eligibility. Two people will independently review each record during title and abstract screening, and three people will independently screen full texts and extract data. Results will be displayed in tables, graphs and narrative summaries in the scoping review.

As the review will only include previously published data, ethics approval is not required. Findings will be shared at scientific conferences and in a peer-reviewed journal.

Cardiovascular disease is a major complication of type 1 diabetes (T1D). There is evidence of cardiovascular damage in children who have T1D but it is unclear how and when the cardiovascular damage begins. There is also minimal data on cardiovascular complications in children with T1D living in Canada. The goal of this project is to determine the timing and factors leading to vascular damage in children (aged 8–18 years) from T1D diagnosis.

This is a prospective longitudinal cohort study investigating vascular health in children through the first 2 years of T1D diagnosis living in Metro Vancouver, Canada. The primary outcomes of the study include changes in arterial stiffness (pulse wave velocity; Augmentation Index), clinic and 24-hour ambulatory blood pressure, and blood biomarkers of vascular damage. Secondary outcome measures include body composition, surrogate markers of adiposity (Body Mass Index, waist circumference), and nutritional assessment, physical activity, glycated haemoglobin (A1C), and to determine the relationships to measures of arterial stiffness, 24-hour ambulatory blood pressure and blood biomarkers of vascular damage. We will also collect sociodemographic data and pubertal status (Tanner staging). Assessments will be performed at diagnosis (within 14 weeks of T1D diagnosis; baseline) and at 6, 12, 18 and 24 months post-diagnosis.

This protocol has been approved by the University of British Columbia Clinical Research Ethics Board and the Children’s and Women’s Health Centre of British Columbia Research Ethics Board (H21-03109). Results will be disseminated through clinical and community presentations and peer-reviewed manuscripts. We will also present our findings to people living with T1D, such as the Young & T1 group.

NCT05790785.

The study aims to assess the magnitude of acute gastroenteritis and associated factors among under-five children visiting public hospitals in Jigjiga City, Somali Region, Ethiopia.

A hospital-based cross-sectional study design was used to carry out the study. We then employed a systematic random sampling technique through face-to-face interviews to gather the data. A structured questionnaire consisting of socio-demographic, behavioural, environmental and clinical factors was developed after reviewing relevant literature.

The study was conducted in public hospitals located in Jigjiga City, Somali Region, Ethiopia.

A total of 353 under-five children visiting public hospitals were involved in the study.

The primary outcome of the study was the prevalence of acute gastroenteritis.

The 2-week prevalence of acute gastroenteritis among under-five children was 24.6% (95% CI 23.4% to 25.9%). The study found strong links between acute gastroenteritis and having a household greater than five (adjusted OR (AOR)=2.94, 95% CI 1.55 to 5.60), an unprotected source of drinking water (AOR=2.74, 95% CI 1.29 to 5.82), unimproved latrine facilities (AOR=3.15, 95% CI 1.26 to 7.78), the presence of faeces around the latrine (AOR=3.53, 95% CI 1.77 to 7.03) and mothers or caregivers’ history of diarrhoea over the past 2 weeks (AOR=6.23, 95% CI 3.22 to 12.06).

The overall prevalence of acute gastroenteritis in Jigjiga City was relatively high in the 2-week period. Having a household greater than five, an unprotected source of drinking water and unimproved latrine facilities was a significant predictor of acute gastroenteritis. Additionally, the presence of faeces around the latrines and the history of diarrhoea in mothers or caregivers over the past 2 weeks were strongly linked to acute gastroenteritis.

Vaping among children and young people (CYP) has increased globally over the past decade, with rates stabilising in the UK in recent years. Factors such as curiosity, social influence, stress management and attractive flavours contribute to its popularity. Although the long-term health impacts are uncertain, vaping poses risks including nicotine dependence, cardiovascular and respiratory issues, and cognitive impairment, though evidence on long-term effects is still emerging. Despite established smoking cessation programmes for adults, tailored resources for vaping cessation among CYP remain scarce, particularly within healthcare settings, which offer unique opportunities for professional intervention and ongoing support. The objective of this review is to assess the extent and nature of available literature on interventions delivered in healthcare settings to support vaping cessation among CYP under the age of 18 years.

This scoping review will include studies targeting CYP under the age of 18 years, specifically focusing on interventions delivered within healthcare settings. Studies outside healthcare contexts or those without healthcare provider involvement will be excluded. Additionally, interventions delivered solely to parents or carers will not be considered.

A comprehensive search will be conducted in MEDLINE, Embase, Web of Science, Cochrane Library and CINAHL from January 2004 to present, with additional grey literature from sources including grey literature repositories and Google Scholar. Results will be imported into Rayyan for screening, with two independent reviewers assessing studies for inclusion. Data extraction will include study design, population characteristics (including explicit age ranges, specifically CYP under 18 years), intervention details and outcomes. A descriptive synthesis will map study characteristics, while thematic analysis will identify intervention themes and healthcare contexts.

Ethics approval is not required for this secondary analysis. Findings will be disseminated through publication, conference presentations and shared with public health stakeholders.

Preterm infants are at risk of developmental impairment, especially those born before 33 weeks gestational age. Many studies have shown a positive impact of early interventions on medical outcomes during hospitalisation, long-term cognitive development and parental anxiety. Infant Behavioral Assessment and Intervention Program (IBAIP) has shown positive effects on cognitive development but also on motor impairment in a Dutch cohort. We aim to confirm these results in a multicentric, cluster randomised controlled trial in a French setting.

Eight French neonatal intensive care units (NICUs) will be randomised before study initiation to intervention or control group. We aim to include 240 infants born between 25 weeks and 33 weeks gestational age. IBAIP intervention comprises monthly home visits with a trained professional from hospital discharge until 6 months corrected age. Both groups receive standard care according to local organisation. The primary endpoint is composite cognitive score at 2 years corrected age using Bayley Scale of Infant Development Fourth Edition (BSID IV). Secondary endpoints include BSID IV subscores, Ages and Stages Questionnaire scores and parental stress. Analysis is in intention to treat. Univariate and multivariate analysis will be performed on primary and secondary endpoints.

Informed consent from one or both parents will be necessary for all patients. Study results will be published in peer-reviewed scientific journals. If our hypothesis is confirmed, IBAIP could be implemented on a nationwide scale. The study was registered with clinicaltrials.gov (ID: 29BRC17.0219).

NCT04685356.

Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with Ureaplasma species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, Ureaplasma exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on Ureaplasma-associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with Ureaplasma in very immature preterm infants born Ureaplasma colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.

This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for Ureaplasma colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.

The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.

German Clinical Trials Register (DRKS00033001).

Delirium is one of the most common forms of acute cerebral dysfunction in critically ill children, leading to increased morbidity and mortality. The aim was to identify studies describing or evaluating non-pharmacological interventions to prevent or treat paediatric delirium.

Scoping review.

Searches were performed in Medline, CINAHL, Cochrane Library, Ovid (Journals), EMBASE and Web of Science from January 2000 to April 2023. A hand search and update were conducted on 01 June 2024.

We included studies involving critically ill children (0–18 years) in intensive care settings that examined non-pharmacological interventions for the prevention or treatment of paediatric delirium. Only empirical studies and reviews with transparent methodology were considered.

Title and abstract screening and full-text review of articles were conducted by two reviewers based on prespecified inclusion criteria. Two reviewers extracted relevant information from the included studies in tabular form. Extracted variables included publication year, title, author(s), country, setting, population and age, design, sample size, intervention components, outcome(s) and findings.

Nine studies were included. In total, 16 different intervention components were identified. The most frequently reported components for preventing and treating paediatric delirium were promoting mobilisation, encouraging family presence and involvement, improving sleep, and standardised instruments or checklists for underlying aetiology. Most intervention studies were before-and-after studies; overall, seven different outcomes were used. Study results regarding the effects of delirium were inconsistent.

Various non-pharmacological interventions are currently described to mitigate paediatric delirium, but the underlying evidence is limited. High-quality intervention research using relevant and comparable outcomes is needed to evaluate the effect of non-pharmacological interventions. Despite employing a comprehensive search strategy, we must consider the possibility that relevant articles were overlooked.

Neonatal death and later disability remain common sequelae of hypoxic-ischaemic encephalopathy (HIE) despite the now standard use of therapeutic hypothermia (HT). New therapeutic approaches to brain protection are required. Melatonin is an indolamine hormone with free-radical scavenging, antiapoptotic, anti-inflammatory and gene regulatory neuroprotective properties, which has extensive preclinical evidence of safety and efficacy. Pharmacokinetic (PK) data suggest it is necessary to reach melatonin levels of 15–30 mg/L within 6–8 hours of hypoxia-ischaemia for brain protection. We developed a novel Good Manufacturing Practice (GMP) grade melatonin in ethanol 50 mg/mL solution for intravenous use. In preclinical studies, ethanol is an adjuvant excipient with additional neuroprotective benefit; optimised dosing protocols can achieve therapeutic melatonin levels while limiting blood alcohol concentrations (BACs).

The Acute High Dose Melatonin for Encephalopathy of the Newborn (ACUMEN) Study is a first-in-human, international, multicentre, phase 1 safety study of intravenous melatonin in babies with moderate/severe HIE receiving HT. Sixty babies will be studied over two phases: a dose escalation study including four dose levels to establish the recommended phase 2 dose (RP2D), followed by a 6-month cohort expansion study of RP2D to further characterise PKs and affirm safety. Participants will receive a 2-hour intravenous infusion of melatonin within 6 hours of birth, followed by five maintenance doses every 12 hours to cover the period of HT. Plasma melatonin and BACs will be monitored. The RP2D will be based on the attainment of therapeutic melatonin levels while limiting BACs and the frequency of dose-limiting events (DLEs). A Bayesian Escalation with Overdose Control approach will be used to estimate the risk of DLE per dose level, with a target level of

Approval has been given by the London Central National Health Service Health Research Authority Ethics Committee (25/LO/0170) and UK Clinical Trials Authorisation from the Medicines and Healthcare products Regulatory Agency. Separate approvals have been sought in Ireland and Australia. Dissemination will be via peer-reviewed journals, conference presentations, public registries and plain language summaries for parent/legal guardian(s), in accordance with national requirements.

ISRCTN61218504. EU CT: 2025-520538-49-00.

Publication based on the UK protocol V.3.0, 08 May 2025

The objective of this study was to identify risk factors for enema reduction failure and to establish a combined model that integrates deep learning (DL) features and clinical features for predicting surgical intervention in intussusception in children younger than 8 months of age.

A retrospective study with a prospective validation cohort of intussusception.

The retrospective data were collected from two hospitals in south east China between January 2017 and December 2022. The prospective data were collected between January 2023 and July 2024.

A total of 415 intussusception cases in patients younger than 8 months were included in the study.

280 cases collected from Centre 1 were randomly divided into two groups at a 7:3 ratio: the training cohort (n=196) and the internal validation cohort (n=84). 85 cases collected from Centre 2 were designed as external validation cohort. Pretrained DL networks were used to extract deep transfer learning features, with least absolute shrinkage and selection operator regression selecting the non-zero coefficient features. The clinical features were screened by univariate and multivariate logistic regression analyses. We constructed a combined model that integrated the selected two types of features, along with individual clinical and DL models for comparison. Additionally, the combined model was validated in a prospective cohort (n=50) collected from Centre 1.

In the internal and external validation cohorts, the combined model (area under curve (AUC): 0.911 and 0.871, respectively) demonstrated better performance for predicting surgical intervention in intussusception in children younger than 8 months of age than the clinical model (AUC: 0.776 and 0.740, respectively) and the DL model (AUC: 0.828 and 0.793, respectively). In the prospective validation cohort, the combined model also demonstrated impressive performance with an AUC of 0.890.

The combined model, integrating DL and clinical features, demonstrated stable predictive accuracy, suggesting its potential for improving clinical therapeutic strategies for intussusception.

Poor linear growth over time can lead to stunting, a significant public health problem in low-resource settings. Catch-up growth, the process of accelerated growth following growth faltering, is important for mitigating the long-term impacts of early stunting. This study aimed to identify key predictors of growth over time, stunting and catch-up growth among children in rural Tanzania.

We evaluated 182 children from the Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development cohort, whose anthropometric measurements were collected at six points from birth to 11.5 years. We assessed outcomes of height-for-age z-score (HAZ), stunting and catch-up growth using mixed-model linear and logistic regression to assess associations of maternal education, household income, socioeconomic status, insulin-like growth factor 1 (IGF-1) and thyroid function tests. We defined stunting as HAZ ≤–2 and catch-up growth both as stunting resolved from age 2 years to 11.5 years and a HAZ increase of >0.5 from 2 years to 11.5 years.

Cohort participants exhibited a moderate amount of catch-up growth, with per cent stunting decreasing from 72.6% at 2 years to 39.0% at 11.5 years. Maternal education, household income, socioeconomic status and IGF-1 were positively associated with HAZ (eg, IGF-1 point estimate 0.141±0.067, p=0.036) and negatively associated with odds of stunting across time points, while thyroid-stimulating hormone was negatively associated with HAZ and positively associated with odds of stunting (all p

These findings highlight the need for comprehensive interventions that address socioeconomic, hormonal and biological factors to promote catch-up growth and reduce stunting in resource-limited settings. The results offer valuable insights towards improving child health outcomes in similar contexts.

NCT02441426 (post-results) and NCT05121935.