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Physiological-behavioural discordance in paediatric perioperative anxiety assessment: a scoping review protocol

Por: Guo · S. · Liu · H. · Wang · L. · Zhang · H.
Introduction

Preoperative anxiety in children is a common problem in paediatric surgical care. In current practice, anxiety is assessed mainly by behavioural rating scales, of which the modified Yale Preoperative Anxiety Scale (mYPAS) is the most widely used. However, behavioural observation may not capture children whose outward behaviour stays calm while their autonomic stress response is still high. This mismatch between visible behaviour and underlying physiology can lead to under-recognition of anxiety and may explain the modest correlations reported between behavioural scores and physiological markers in children. The aim of this scoping review is to map the published evidence on physiological–behavioural discordance during paediatric perioperative anxiety and to identify methodological gaps that future multimodal assessment research will need to address.

Methods and analysis

The review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews reporting guideline and the Joanna Briggs Institute methodology for scoping reviews. We will search PubMed/MEDLINE, Embase, Web of Science Core Collection, CINAHL Complete and PsycINFO from database inception to 31 December 2025. Eligible studies will recruit children aged 0 to 18 years in perioperative or analogous procedural settings, and will report both a behavioural anxiety measure (such as mYPAS, mYPAS-SF, State–Trait Anxiety Inventory for Children (STAI-C)) and at least one concurrent physiological stress indicator (heart rate variability, salivary cortisol, salivary alpha-amylase, electrodermal activity, heart rate or intraoperative nociception indices). The primary analysis will focus on perioperative anaesthesia induction. Procedural sedation, venipuncture and dental contexts will be analysed as a separate secondary stratum because their stress profile is not the same as anaesthesia induction. Two reviewers will screen and extract data independently. Premedication exposure, regular home psychoactive medication use (including cannabinoids) and the time gap between behavioural and physiological sampling will be extracted as prespecified confounders. Findings will be synthesised narratively following the Synthesis Without Meta-analysis reporting guideline.

Ethics and dissemination

Ethical approval is not required because the review uses only published literature. Results will be submitted to a peer-reviewed journal and presented at paediatric anaesthesia conferences. A plain-language summary will be co-produced with parent advisors.

Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol

Por: Werner · O. · Ferchaud-Roucher · V. · Karakachoff · M. · Bourgoin · P. · Chauvire-Drouard · A. · Galy · J. · Cosse · M. · Chaffiraud · M. · Boivin · M. · Gauvard · E. · Egron · S. · Romefort · B. · Benbrik · N. · Padovani · P. · Prigent · S. · Tagorti · M. · Demonceaux · M. · Gronier · C.
Introduction

Critical congenital heart disease (CHD) is associated with neurodevelopmental disorders, recognised as the most common long-term morbidity in affected children. In critical CHD, that is, CHD requiring cardiac surgery within the first 3 months of life, 30%–50% of children have lower developmental scores. Therefore, early identification of at-risk infants is crucial, yet there is no scientifically evaluated care programme in France. This study aims to evaluate early neurodevelopmental status in infants with prenatally diagnosed critical CHD and to determine how intrinsic susceptibility, prenatal and postnatal factors are functionally associated with developmental delay in this population.

Methods and analysis

Caractérisation et Accompagnement des Troubles du neurodéveloppement Associés aux MAlfoRmations cArdiaques coNgénitales (CATAMARAN) is a prospective, multicentre cohort study including 150 fetuses with critical CHD and their parents across eight French tertiary CHD centres. The primary objective will be to estimate the proportion of developmental delay at 6 months using the Bayley Scales of Infant and Toddler Development. Secondary objectives will include exploring potential prenatal, perinatal, perioperative determinants of developmental delay. Data collection will span pregnancy to 6 months of age including clinical assessments, maternal questionnaires (stress and nutrition), multimodal imaging and extensive biobanking (placenta, cord and peripheral blood, stool samples). To explore potential genetic and other multi-omic factors involved in the occurrence of a developmental delay, a case-control analysis will be conducted within the cohort.

Ethics and dissemination

Clinical and biological data will be collected through a secure system, with anonymised samples analysed in specialised facilities under collaborative agreements. Data confidentiality, traceability and long-term storage are ensured through controlled access and audit trails. Study results will be published and shared with families and the public through the patient association Petit Coeur de Beurre. This study received approval from a French ethics committee in November 2024 (no. 2024-A00425-42).

Trial registration number

NCT06690151.

AllPlay Dance autism: protocol for a randomised controlled trial of a community-based dance programme for children with autism

Por: Chadha · M. · Lindor · E. · Millard · O. · Moss · S. · Rinehart · N.
Introduction

Motor skills are integral to numerous developmental domains throughout infancy and childhood. In autism, motor impairments are prevalent and pervasive, often appearing before core symptoms. These motor difficulties have a cascading effect on a child’s broader physical and psychological health, including social, cognitive, emotional and behavioural functioning. Accordingly, researchers are increasingly interested in interventions that improve motor functioning, as these may have a downstream effect on broader developmental domains. One intervention that could address motor difficulties is the AllPlay Dance programme, which provides inclusive dance classes to children in community settings, with pilot data demonstrating acceptability and feasibility among parents and their children with autism and cerebral palsy. This pragmatic randomised controlled trial (pRCT) is thus designed to evaluate whether the AllPlay Dance programme creates the conditions for motor, cognitive and social abilities to thrive in children with autism.

Method and analysis

This pRCT intends to enrol 70 families of children with autism, aged 7–12 years, living in Victoria, Australia. We will also enrol up to 60 participants with previous dance experience, called buddies, to support the participation of our dancers with autism. We will use our clinical, research, university and community networks to recruit participants. Interested families will complete an online screening survey, followed by questionnaires that parents complete and assessments of the motor functioning in the children. Interested buddies will also complete an online screening survey followed by a baseline questionnaire. Families will be randomly allocated to the intervention group or the treatment-as-usual waitlist control group. The intervention group will attend 9 weeks of community-based dance classes led by disability and dance experts and supported by buddies. The primary outcome is change in motor functioning, as assessed through performance-based measures, with parent reports providing complementary information about everyday motor functioning. Secondary outcomes include improvements in the executive, social, emotional and behavioural functioning of the children, as well as decreases in the stress of parents. We will also evaluate the acceptability and feasibility of this programme, as well as whether families decide to enrol and engage with other dance programmes in the community following the intervention.

Ethics and dissemination

The study has received approval from the Monash University Human Research Ethics Committee and the Deakin University Human Research Ethics Committee. Findings will be disseminated through a PhD thesis, peer-reviewed publications, presentations at scientific conferences and reports to participants, community organisations and the wider community.

Trial registration number

Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12625000600448; registered on 11 June 2025; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=389672.

School- and home-based hybrid exercise intervention to prevent summer fitness loss in children: protocol for a feasibility study of the keep moving in a structured summer programme

Por: Liu · Y. · Gu · J. · Li · M. · Guo · Q. · Geng · R. · Dai · L. · Xiao · P. · Zheng · Y. · Sun · F.
Introduction

Schools are key settings to intervene for the purpose of health promotion in children. However, the effectiveness of school-based interventions remains limited, potentially related to the obesogenic behaviours observed during holidays as posited by the structured days hypothesis. This study aims to evaluate the feasibility, process evaluation and preliminary efficacy of the keep moving in a structured summer (KEMOSS) intervention among Chinese children.

Methods and analysis

The KEMOSS intervention is an 8-week hybrid programme comprising two digitally supported home-based phases (weeks 1–2 and 7–8) and a structured school-based phase (weeks 3–6). The school-based phase will be a full-day scheduled programme that replicates the routine of regular school days, with a coach-led structured physical activity lesson and a free-play lesson embedded in the morning and afternoon, respectively. During the home-based phases, participants will be encouraged to complete prescribed exercises independently with support from mHealth reminders and instructional materials and to achieve a minimum of 10 000 steps per day. Feasibility, process evaluation and preliminary efficacy outcomes will be assessed using a mixed-methods approach. Quantitative data will be analysed using SPSS, while qualitative data from interviews and focus groups will be analysed thematically using NVivo.

Ethics and dissemination

Ethical approval has been obtained from the Ningbo University Ethics Committee (TY2026028). Findings will inform the refinement of the intervention and the design of a future definitive trial. Results will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

ChiCTR2600126738.

Cohort profile: the Norwegian Triple-S Cohort Study: a large longitudinal study of children and adolescents exposed to maltreatment and their caregivers

Por: Sivertsen · B. · Hysing · M. · Hafstad · G. S. · Kjorstad · K. · Schonning · V. · Woodfin · V. · Ovstebo Naess · S. · Vervik · S. E. · Stokke · K. · Tobiassen · S. · Jonassen · J. A. · Aaro · L. E. · Babaii · A. · Vedaa · O. · Dovran · A.
Purpose

Childhood maltreatment is common and associated with a wide range of adverse outcomes, yet few large, well-designed longitudinal studies follow children and adolescents with substantiated maltreatment over time. The Norwegian Triple-S Cohort Study was established to recruit and follow children and adolescents, together with their non-offending caregiver, to identify key risk and resilience factors and understand long-term health and functioning.

Participants

The cohort invites children and adolescents aged 5–18 years with substantiated maltreatment, including physical abuse, emotional abuse, sexual abuse, neglect or exposure to domestic violence. Participants attend the Stine Sofie Centre, a national learning and coping centre for families affected by maltreatment in Norway. At intake, both the child/adolescent and the non-offending caregiver are invited to participate. Participants are followed at regular intervals after enrolment, typically at 2-year intervals, and, with consent, survey data can be linked to national health, education, employment and social welfare registries. As of June 2026, 733 caregivers and 325 adolescents aged 12–18 years had completed baseline questionnaires. Recruitment is ongoing and will continue until the cohort reaches approximately 1500 participating children and adolescents.

Findings to date

Data collection includes information on children and adolescents’ maltreatment type, mental and somatic health, behavioural and neurodevelopmental symptoms, self-harm and suicidality, sleep, social relationships, school functioning, health behaviours and service use. Caregiver data cover mental and physical health, self-harm and suicidality, interpersonal victimisation across the life course, socioeconomic and lifestyle factors, parenting practices, family dynamics and relationship quality and perceived service needs. Published analyses have documented substantial mental health and sleep difficulties, impaired school functioning and high levels of non-suicidal self-harm among children and adolescents exposed to maltreatment. Other studies have shown considerable variation in service use and coordination, and that emotional, relational and practical barriers may hinder disclosure. Analyses of caregiver data have also highlighted both relational strengths and areas of difficulty in parenting, as well as socioeconomic vulnerability among mothers with cumulative exposure to interpersonal violence across childhood and adulthood.

Future plans

Continued follow-up will enable detailed investigation of long-term outcomes after substantiated childhood maltreatment, including trajectories of mental health, education, work participation and service use. The cohort will be used to identify key risk and protective factors, including intergenerational patterns of adversity and resilience. Planned linkages to national registries will provide comprehensive life-course data, and additional data collection within the cohort through qualitative interviews is intended to offer deeper insight into the lived experiences of children and caregivers. Findings will inform prevention efforts and contribute to improved service delivery and coordination for maltreated children and their families.

Intraventricular haemorrhage (IVH) and associated clinical characteristics in outborn preterm infants <32 weeks undergoing neonatal transport in Western Australia: a retrospective cohort study (2011-2021)

Por: Desai · S. · Joseph · M. · George · K. · Tan · K. N. · Dempsey · Z. · Cooper · M. · White · S. · Sharp · M. · Davis · J.
Objectives

To evaluate maternal, infant and transport factors associated with intraventricular haemorrhage (IVH) in outborn preterm infants <32 weeks’ gestation in Western Australia.

Design

Retrospective cohort study.

Setting

Newborn emergency transport service of Western Australia (NETS WA).

Participants

Preterm infants <32 weeks’ gestation born outside the tertiary perinatal centre and transported by NETS WA between 2011 and 2021. Exclusions were congenital anomalies, transfer after day 1 of life or death before day 1 cranial ultrasound.

Outcomes

Outcome was any IVH detected on cranial ultrasound on day 1 and day 7 of life. Perinatal data were analysed comparing infants with and without IVH using bivariate tests and logistic regression to examine differences between these groups.

Results

IVH occurred in 57/286 (19.9%) on day 1 and 53/275 (19.9%) on day 7; severe IVH occurred in 25/286 (8.7%) and 27/275 (9.9%), respectively. Infants with IVH had lower gestational age and birth weight, greater exposure to intra-amniotic inflammation and less antenatal steroid exposure. In multivariable analyses, intra-amniotic inflammation was associated with increased odds of IVH on day 1 (OR 2.47, 95% CI 1.10 to 5.44). Epinephrine use during resuscitation was associated with higher odds of IVH on day 1 (OR 4.88, 95% CI 1.49 to 17.5). Inotrope use during transport was associated with IVH on day 1 (OR 7.85, 95% CI 1.35 to 54.6) and day 7 (OR 9.11, 95% CI 1.32 to 72.9). Continuous positive airway pressure during transport was associated with lower odds of IVH on day 1 (OR 0.32, 95% CI 0.10 to 0.88). Transport mode, duration and timing intervals were not associated with IVH.

Conclusions

In outborn preterm infants <32 weeks’ gestation, IVH risk was more strongly associated with perinatal factors than transport characteristics. Collaboration across perinatal networks should aim to support optimal management during preterm labour birth.

PREVENT 1, a nationwide Swedish infant cohort for longitudinal gut microbiome profiling and early-life health outcomes: cohort profile

Por: Orwa · S. · Vlajic · M. · Cavani · E. · Devall · A. E. · Hugerth · L. W. · Brusselaers · N. · De Vos · W. M.
Purpose

PREVENT 1 is a nationwide, prospective Swedish infant cohort established to characterise gut microbiome development during the first 2 years of life and to relate microbial trajectories to feeding, infections, growth and everyday well-being. The study integrates repeated infant stool sampling with shotgun metagenomics analysis with aligned parental questionnaires, stool photographs and infant cry recordings collected at three approximately 3-month intervals for each infant.

Participants

Families were recruited nationwide in Sweden from September 2023 through targeted digital channels. Eligible participants were term-born infants residing in Sweden and aged

Findings to date

Retention was high, with 248 families completing at least one follow-up questionnaire at Phase 2 and 243 at Phase 3. For stool samples, 250 infants provided at least two samples and 241 provided all three. At enrolment, 42.3% of infants were older than 7 months, 73.9% had weight-for-length z-scores in the normal range and exclusive breastfeeding at 4 months was reported for 58.9%.

Future plans

Three-phase sample and questionnaire data collection was completed in December 2024. Future analyses will examine microbiome features, resistome profiles and functional pathways in relation to antibiotic exposure, feeding, growth and infant health outcomes. Subject to ethical approval and participant consent, follow-up may include further stool collection and Swedish register linkage.

Trial registration number

NCT06285630.

Determinants of neonatal size and body composition: protocol of a prospective cohort study of mother-newborn pairs in Bloemfontein, South Africa

Por: Carboo · J. A. · Garland · M. · Moolman · E. · Walsh · C. M.
Introduction

Neonatal size and body composition, including fat mass and fat-free mass, are influenced by maternal nutritional status, lifestyle and overall health during pregnancy. Paternal health and household factors may also be contributory to neonatal body composition and subsequent growth trajectories. Neonatal anthropometry and body composition are important predictors of early morbidity, growth faltering, stunting and childhood adiposity and long-term risk of obesity and non-communicable diseases (NCDs). In South Africa, 28% of children under 5 years are stunted, alongside a growing overweight and obesity prevalence and NCD risk in children. Limited evidence exists regarding the maternal and paternal determinants of neonatal body composition in this setting.

Methods and analysis

This prospective cohort study aims to investigate maternal and paternal nutritional, health, body composition and lifestyle factors that influence neonatal size and body composition in Bloemfontein. The study will enrol 200 mother–neonate pairs at birth from Universitas Academic Hospital and follow them to 6 weeks postpartum. Maternal assessments at enrolment include anthropometry, body composition (using bioimpedance analysis), dietary intake, medical history, mental health, household food security and socio-economic and lifestyle factors. Neonatal measurements include birth weight and length, gestational age and body composition (using air displacement plethysmography). Paternal data include anthropometry, body composition, dietary intake, chronic disease risk and lifestyle factors, including alcohol use and smoking. At 6 weeks postpartum, infant feeding practices, growth and body composition are assessed. Multiple linear and logistic regression models will be used to assess the relationships between maternal and paternal factors and neonatal outcomes.

Ethics and dissemination

This study is approved by the Health Sciences Research Ethics Committee of the University of the Free State and the Free State Department of Health. Findings of this study will be published as scientific articles in peer-reviewed journals, presented at scientific conferences and workshops and disseminated at hospital staff forums and in local media.

Development of Cereblon (CRBN) as an early prognostic biomarker in Paediatric Sepsis: a Prospective Observational Study Protocol

Por: Mishra · N. · Gupta · A. · Gupta · R. · Kumar · M. · Shukla · A.
Introduction

Paediatric sepsis remains a formidable challenge in global child health, contributing significantly to morbidity and mortality, especially in resource-constrained settings. Accurate early prognostication of disease trajectory is imperative for effective triage and timely intervention; however, existing biomarkers and clinical scoring systems are often limited by insufficient specificity, operational complexity or limited applicability across diverse clinical settings. One potential avenue for improving early prognostication is investigating novel biomarkers. Cereblon (CRBN), a multifunctional protein implicated in immune modulation, has shown variable associations with outcomes in adult sepsis, while its role in paediatric sepsis remains unexplored. This study aims to assess the potential of CRBN expression as an early prognostic biomarker in paediatric sepsis, thereby informing clinical decision-making and improving patient outcomes.

Methods and analysis

This prospective observational paediatric intensive care unit (PICU)-based study will enrol 240 children aged 2 months to 15 years with sepsis using a consecutive non-probability sampling method. Pediatric Sequential Organ Failure Assessment (pSOFA) scores will be recorded at admission and at 24 hours. Blood samples will be collected at admission to assess CRBN mRNA expression by quantitative real-time PCR and protein levels by ELISA. The primary outcome will be the correlation of CRBN with 28-day mortality. Secondary outcomes will assess its correlation with the pSOFA score, C-reactive protein, duration of mechanical ventilation and duration of PICU stay. CRBN levels will be compared between survivors and non-survivors, and correlations with pSOFA score, inflammatory markers and clinical outcomes will be assessed using Pearson’s or Spearman’s tests as appropriate. Prognostic performance will be assessed using Receiver operating characteristics (ROC) curve and area under curve (AUC) value with Youden-derived cut-offs. Multivariable regression will be performed to adjust for key confounders.

Ethics and dissemination

Ethical approval was obtained from the Institutional Ethics Committee, All India Institute of Medical Sciences, Raebareli, prior to study initiation (IEC Code-2024-4-EMP-EXP-9). Written informed consent will be obtained from parents or guardians. The study findings will be disseminated through peer-reviewed publications and scientific conferences. The reporting of study results will adhere to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines to ensure transparency and completeness.

Association of caffeine citrate administration with necrotising enterocolitis in infants < 32 weeks gestation: a retrospective cohort study

Por: Hu · X. · Yuan · L. · Wang · Q. · Zhu · L. · Dang · D. · Fu · Y. · Gong · H. · Han · S. · Yang · J. · Chinese Neonatal Network
Objective

To examine the association between caffeine citrate administration and necrotising enterocolitis (NEC) in very preterm infants (VPIs).

Design

A multicentre retrospective cohort study.

Setting

Level III neonatal intensive care units participating in the Chinese Neonatal Network.

Participants

The participants comprised neonates with a gestational age of under 32 weeks.

Interventions

Exposure to caffeine citrate administration after birth.

Primary and secondary outcome measures

Primary outcome measures were the incidence of NEC (≥stage IIA) and surgical NEC. Secondary outcome measures included severe neonatal morbidities, including severe intraventricular haemorrhages, severe retinopathy of prematurity, late-onset sepsis, bronchopulmonary dysplasia, death, duration of parenteral nutrition and length of neonatal intensive care unit stay.

Results

A total of 45 624 VPIs were included. Among 36 514 who received at least one dose of caffeine citrate, 2315 (6.3%) developed NEC (≥stage IIA) and 849 (2.3%) experienced surgical NEC. Among 9110 VPIs without caffeine exposure, 544 (6.0%) developed NEC (≥stage IIA) and 263 (2.9%) experienced surgical NEC. Caffeine citrate exposure did not affect the incidence of NEC (≥stage IIA) between groups (adjusted OR (aOR), 1.01; 95% CI 0.83 to 1.24; adjusted absolute risk (aAR), –0.15; 95% CI –1.21 to 0.92); however, its early administration (within 72 hours after birth) was associated with a lower incidence of surgical NEC (aOR, 0.76; 95% CI 0.64 to 0.89; aAR, –0.92; 95% CI –1.55 to –0.29). In subgroup analysis, caffeine citrate administration was associated with a reduction in the incidence of NEC (≥stage IIA) among VPIs receiving invasive ventilation at admission (aOR, 0.8; 95% CI 0.67 to 0.94; aAR, –2.04; 95% CI –3.82 to –0.25) and vasopressors before NEC occurred (aOR, 0.64; 95% CI 0.52 to 0.78; aAR, –5.17; 95% CI –7.94 to –2.39).

Conclusions

While the incidence of NEC (≥stage IIA) in VPIs has not been affected by caffeine citrate, early administration (within 72 hours after birth) was associated with a reduced incidence of surgical NEC. Furthermore, among VPIs who received invasive ventilation at admission and vasopressors, the administration of caffeine citrate was potentially correlated with a decreased occurrence of NEC (≥stage IIA).

The SMART-Youth study: protocol for a longitudinal prospective cohort study to identify disease-associated and lifestyle-associated cardiovascular risk factors for preclinical atherosclerosis in children with a chronic condition

Por: van der Linden · I. A. · Muilwijk · D. · Raijmakers · J. J. D. · Destoop · M. · Hoefnagels · J. W. · Terstappen · F. · Bots · M. L. · Vaartjes · I. C. H. · Koopal · C. · Visseren · F. L. J. · Slieker · M. G. · Breur · J. M. P. J. · Frenkel · J. · Lilien · M. R. · van Montfrans · J.
Introduction

Cardiovascular risk assessment and management in the paediatric population is a relatively uncharted territory. However, atherogenesis starts during childhood, making childhood and adolescence an important window of opportunity to prevent atherosclerotic cardiovascular disease (ASCVD) later in life. An emerging group at risk for early ASCVD are children with chronic conditions. This paper describes the rationale, design and methods for the Secondary Manifestations of ARTerial diseases in the Young with a chronic condition (SMART-Youth) study. This study aims to identify disease-associated and lifestyle-associated cardiovascular risk factors for preclinical atherosclerosis in children with a chronic condition. The results of this study may fuel development of tailored cardiovascular risk assessment and management strategies in children at-risk.

Methods and analysis

This is a prospective longitudinal cohort study including children aged 8–18 years with various chronic conditions (cystic fibrosis, juvenile idiopathic arthritis, systemic autoimmune disease, chronic kidney disease, primary immunodeficiency, autoinflammatory conditions, inflammatory bowel disease, congenital heart disease, premature birth, fetal growth restriction and children with persistent somatic symptoms) at the Wilhelmina Children’s Hospital of the University Medical Center Utrecht in The Netherlands. Assessment of cardiovascular risk factors includes blood pressure, body mass index, visceral and subcutaneous abdominal adipose tissue, nutrition, physical activity, stress, circulating lipids, HbA1c and C-reactive protein measurements. Preclinical atherosclerosis is measured by carotid intima-media thickness, carotid distension and carotid-femoral pulse wave velocity. These assessments are performed at baseline, 2-year follow-up and 17–18 years of age. Enrollment runs from August 2024 onwards, with a minimal study duration of 15 years and an estimated final sample of more than 2000 children. State-of-the-art regression-based methods will be used to examine the association of cardiovascular risk factors and preclinical atherosclerosis. Longitudinal data analysis methods will be used to model these associations over time.

Ethics and dissemination

Ethical approval was granted by the Medical Ethics Review Board of the University Medical Center Utrecht (NL84874.041.23). Written informed consent by participants and their parents is required for participation. Collected data will be made available to researchers upon reasonable request to the Steering Committee. Study findings will be disseminated through peer-reviewed publications, presentations at scientific meetings and meetings with patient organisations.

Surveillance for neurodevelopmental impairment (NDI) in high-risk neonates: a cohort study at a tertiary care hospital in Pakistan

Por: Jafri · S. K. · Mazhar · N. · Mirza · A. · Zehra · T. · Shams · Z. · Naseem Elahi · K. · Das · J. K. · Iqbal Siddiqui · M. · Bhamani · S. · Tayyab · H. · Rizvi · A. · Ibrahim · S.
Background

High-risk neonates are at greater risk for neurodevelopmental impairment (NDI) despite improved neonatal survival. In low-income and middle-income countries, including Pakistan, developmental trajectories across infancy and toddlerhood of high-risk neonates are not well studied, especially when the survival is improving.

Methods

This 2-year longitudinal cohort study was performed at the neonatal intensive care unit and Child Development and Rehabilitation Centre of Aga Khan University Hospital in Pakistan. High-risk neonates who met predefined clinical criteria were enrolled and evaluated at 6 months, 12 months and 24 months of age using the Bayley Scales of Infant and Toddler Development, Fourth Edition. NDI has been defined as moderate–severe hearing or visual impairment, cerebral palsy or global developmental delay (ie, ≥2 SD delay in ≥2 Bayley domains).

Results

Out of 369 eligible neonates, 198 of them had at least one assessment. NDI prevalence increased to 15.7% at 2 years compared with 8.2% at 6 months. Overall, language impairment showed the largest increase (2.6%–9.6%), while cognitive (5.2%–7.1%) and motor (5.2%–7.6%) impairments rose modestly.

Placental abruption was linked to the risk of NDI in univariable analysis (HR=3.53, 95% CI 1.07 to 11.62). Low birth weight was associated with gross motor impairments (HR=2.90, p=0.01), while preterm birth also showed association with gross motor (HR=3.66, p=0.01) and receptive (HR=2.61, p=0.02) impairments. Receptive language impairment was related to pre-eclampsia (HR=2.06, 95% CI 1.17 to 3.64) and preterm premature rupture of membranes (HR=2.24, 95% CI 1.22 to 4.09). Expressive impairment was linked to prolonged hospital stay (HR=1.81, 95% CI 1.04 to 3.14) and lower household income (HR=2.07, 95% CI 1.24 to 3.45).

Conclusion

Approximately 15% of high-risk neonatal survivors showed evidence of NDI by 2 years of age with evolving language vulnerabilities and persistent gross motor risks. Overall, study findings highlight the need for urgent structured developmental surveillance and early child development intervention programmes for high-risk infants in Pakistan, as part of routine neonatal care pathways.

Study protocol of the Speech of children After Neonatal Encephalopathy (SANE): a single-centre prospective cohort study

Por: Bodocs · D. L. · Rago · A. · Farkas · N. · Lakatos · A. · Kas · B. · Lukacs · A. · Jermendy · A. · Hernadfoi · M. · Lökkös · E. · Kiss · N. · Banvölgyi · A. · Major · J. · Hegyi · P. · Szabo · M. · Varga · Z.
Introduction

Language development is a key determinant of academic achievement and psychosocial outcome. Due to the therapeutic hypothermia procedure, 75% of children diagnosed with moderate to severe neonatal encephalopathy (E) survive without serious neurological sequelae. Several studies have already revealed the overall cognitive deficits of these infants; however, their long-term language developmental specificities and their attendant neonatal risk markers remain under-investigated.

Methods and analyses

In our single-centre prospective cohort study (n128), we will include only those children with perinatal asphyxia who meet the stepwise criteria of the Total Body Hypothermia (TOBY) study and who survive NE without functional motor deficits and moderate/severe overall cognitive deficits at the second-year follow-up examination. The NE survivors included and cared for in the Level III Neonatal Intensive Care Unit of the Pediatric Center, Semmelweis University, Budapest, Hungary, were born between 2017 and 2022. Clinical, laboratory, electrographic and neuroimaging data will be extracted from their medical records and will be evaluated retrospectively. Patients will be followed up to assess overall cognitive and language development between 4 and 8 years. The association between neonatal biomarkers and developmental language disorder (DLD) will be analysed with binary logistic regression models. Machine learning techniques will be used to develop predictive models for DLD. For modelling the longitudinal changes between early (2 years) and later (4–8 years) cognitive and language status, mixed effects models will be applied.

Ethics and dissemination

The protocol was approved by the National Centre for Public Health and Pharmacy (NNGYK/24844-9/2025) on 21 May 2025. Results of this study will be disseminated through multiple channels. We will publish the findings in international peer-reviewed scientific journals and present them at national and international conferences.

Trial registration number

NCT07136636.

Effect of paediatric lung ultrasound on antibiotic prescriptions in hospitalised children and adolescents with lower respiratory tract infections: protocol for a randomised, sham-controlled trial (PLUS-AP trial)

Por: Khreis · D. · Hassan · M. · Slika · M. · Raoof · H. · Hamideh · R. · Mahfoud · Z. R. · Ismail · A.
Introduction

Lower respiratory tract infections (LRTIs) remain a major global health problem and a leading cause of childhood morbidity and mortality worldwide. Inappropriate antibiotic use for predominantly viral LRTIs is common and contributes substantially to the public health threat of antimicrobial resistance. Lung ultrasound (LUS) is a radiation-free, bedside imaging tool with high diagnostic accuracy for paediatric pneumonia. We hypothesise that integrating LUS into the care of children hospitalised with LRTIs can improve antibiotic decision-making and safely reduce unnecessary antibiotic prescriptions.

Methods and analysis

The PLUS-AP trial is an ongoing phase III, single-centre, blinded, parallel-group randomised controlled superiority trial conducted at a tertiary hospital in Beirut, Lebanon. Children aged 3 months to 18 years hospitalised with LRTI are randomly assigned (1:1) to LUS-guided management or to standard care with a sham lung ultrasound. In the intervention group, LUS is performed within 24 hours of admission and repeated around 48 hours later or before discharge, and the findings are shared with the treating team to inform management. The control group receives standard clinical evaluation, including chest X-ray as indicated, plus a non-diagnostic sham lung ultrasound. The primary outcome is antibiotic prescription at hospital discharge. Secondary outcomes are hospital length of stay; intensive care unit admission, chest tube insertion, mortality, hospital readmission, frequency of chest radiography performance and antibiotic use for LRTIs, all assessed within 4 weeks after enrolment. A total of 176 participants (88 per arm) will provide adequate power to detect a clinically important reduction in antibiotic prescribing, and analyses will follow the intention-to-treat principle with one planned interim analysis at 50% recruitment.

Ethics and dissemination

The study protocol has been approved by the Institutional Review Board at the American University of Beirut (BIO-2024-0304). Written informed consent (and assent, when applicable) will be obtained for all participants. A Data and Safety Monitoring Committee will oversee patient safety and review interim results. Results will be disseminated through peer-reviewed publications, scientific conferences and targeted outreach to clinical and public health stakeholders to facilitate translation of the findings into routine practice.

Trial registration number

NCT06876766.

Efficacy of cycled environmental light and noise during initial hospitalisation for improved cognitive outcomes at 2 years in infants born extremely or very preterm: study protocol for the prospective, randomised, open, blinded endpoint controlled multice

Por: Pillow · J. J. · Hunt · R. W. · Marsh · J. A. · Anderson · P. J. · Mark · P. J. · Spittle · A. J. · Whitehouse · A. J. O. · Badawi · N. · The CIRCA DIEM Study · Sorensen · Phillipson · Abrahamwilliam · Cameron · Davis · DCruz · Deshpande · Elliott · Gordon · Martinello · Mehta · Ro
Introduction

Very preterm infants (

Methods and analysis

Australasian multicentre, two-arm, parallel-group, prospective, randomised, open, blinded-endpoint superiority trial in 868 infants born less than 32 weeks’ gestation. Infants are randomised to cycled environmental light and noise or routine care in a non-cycled hospital environment from soon after birth until discharge home. The intervention comprises wearing eye-masks and ear plugs from 20:00 to 6:00, followed by removal of these devices and exposure to normal environmental noise and 300-600 lux light from 6:00 to 20:00. The primary outcome is composite cognitive score on Bayley-4 developmental assessment at 2 years corrected postnatal age.

Ethics and dissemination

The trial is approved by the Child and Adolescent Health Service Human Research Ethics Committee under the National Mutual Acceptance Scheme in Australia. Infants are randomised to intervention or control group after informed parental consent is obtained. Results of the CIRCA DIEM Study will be disseminated widely via presentations at local, national and international conferences, publication in international peer-reviewed journals and inclusion on the study website. Information about trial findings will also be communicated directly to the parents/guardians of trial participants through the regular study newsletter. The trial investigators will seek opportunities to communicate study results to the lay public through media and social media avenues.

Trial registration number

ANZCTRN12618000371291.

Comparative performance of 24G and 26G short peripheral catheters in neonates: a single-centre retrospective cohort study in a tertiary neonatal intensive care unit

Por: van Rens · M. F. P. T. · Piersigilli · F. · Elmalik · E. E. · Francia · A. L. V. · van Loon · F. H. J. · Bayoumi · M. A. A.
Background

Short peripheral catheters (SPCs) are the most frequently used vascular access devices in neonates but are associated with complications and limited dwell times. International guidelines recommend using the smallest appropriate catheter gauge, yet 24G SPCs remain the default choice in many neonatal intensive care units (NICUs) while 26G SPCs are less often used because of concerns about flow adequacy particularly during blood transfusions. Evidence directly comparing these gauges in neonates is limited.

Methods

We conducted a retrospective cohort study in a tertiary NICU and national referral centre for high-risk neonatal care in Doha, Qatar. Data were collected between 1 August 2018 and 31 December 2023. Eligible participants were neonates (0–28 days) who received at least one SPC insertion. Data extracted included demographics, catheter characteristics, dwell time, complications and reasons for removal. Analyses were performed at the catheter episode level. Dwell times were analysed using Kaplan–Meier survival curves with log-rank testing, and group comparisons were performed with parametric or non-parametric tests as appropriate.

Results

A total of 45 753 SPC episodes were analysed: 10 531 (23.0%) 24G and 35 222 (77.0%) 26G. Baseline characteristics were comparable between the groups. The mean dwell time was slightly longer for 26G than for 24G (35.1 vs 32.6 hours, pp

Conclusion

In this large neonatal cohort, 26G SPCs were associated with a statistically longer dwell time than 24G SPCs, although the absolute difference was small. Therapy completion and complication rates were comparable between the groups, whereas first-attempt insertion success rates were higher with 26G SPCs.

Exclusive breastfeeding and its determinants among infants attending a tertiary care hospital serving an underprivileged population in Rawalpindi, Pakistan: a cross-sectional study

Por: Tabassum · M. · Ayub · A. · Subhani · F. A. · Awan · F. A. · Ahmad · B. · Ullah · I.
Objective

To determine the pattern and determinants of exclusive breastfeeding (EBF) among infants visiting a tertiary care hospital of underprivileged population.

Design

Cross-sectional study.

Study

The Department of Pediatrics, Pakistan Railway Hospital, Rawalpindi, Pakistan.

Methods

A total of 385 infants, born with gestational age between 34–42 weeks, were analysed. Data collection was performed through a structured questionnaire designed to capture relevant demographic and clinical details. The pattern of breastfeeding (BF), including EBF, formula milk, animal milk (cow/buffalo/goat milk) or mixed methods was determined. The collected data were entered and analysed using IBM-SPSS V.26.

Results

In a total of 385 infants, EBF was reported in 206 (53.5%) infants, while 36 (9.4%) were exclusively formula-fed (FF), 122 (31.7%) received a combination of BF and formula feeding (mixed FF and BF), 14 (3.6%) were given a mix of BF and animal milk, and 7 (1.8%) received BF along with water. Age (p=0.033), birth weight (p=0.050), mode of delivery, neonatal intensive care unit (NICU) admission (p=0.028), BF initiation timing (p

Conclusions

Despite the well-established benefits of EBF, only around half of the infants were exclusively breastfed, highlighting the need for targeted interventions. Cesarean delivery, NICU admission and pre-lacteal feeding practices were significant barriers to EBF, while early BF initiation, antenatal counselling and maternal education played pivotal roles in promoting EBF.

Prophylactic antiseizure medication administration practices in neonates with hypoxic-ischaemic encephalopathy: a scoping review protocol

Por: Nalwanga · L. E. · Ayesiga · I. · Ediamu · T. D.
Introduction

Hypoxic-ischaemic encephalopathy (HIE) is a leading cause of neonatal mortality and long-term neurodevelopmental impairment worldwide. Neonatal seizures are common in HIE and are associated with adverse outcomes. While antiseizure medications are routinely used for treatment, their prophylactic use in the absence of clinically evident seizures remains controversial, with limited consensus and variable clinical practices. Therefore, this review will map the existing evidence concerning the utilisation of antiseizure medication for prophylaxis among neonates with HIE.

Methods and analysis

The review will follow the Joanna Briggs Institute scoping review methodology and be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. A comprehensive search will be conducted across various scientific databases, including PubMed, Embase, Scopus and Web of Science, guided by the Population, Intervention, Concept and Context framework, starting between October and November 2026. The review will consider studies on the prophylactic use of antiseizure medication among neonates with HIE. The collected search results will be organised and uploaded to Covidence, where duplicates will be removed, and titles and abstracts will be screened. Search and screening processes have not yet started.

Ethics and dissemination

This will be a secondary study using already published information; therefore, ethical approval was not sought. All studies included in this review will be cited accordingly, as attributed to the publication licence. The data gathered will be summarised in a scoping review and submitted for publication in an international peer-reviewed journal. Datasets shall also be made publicly available in a data repository, such as the Open Science Framework.

Protocol for a digital health-assisted cluster randomised controlled trial to prevent obesity in preschool children in Jinan, China

Por: Zhang · L. · Yan · S. · Yin · C. · Zhang · Y. · Liu · H. · Gao · M. · Zhang · Z. · Duan · X. · Wang · H. · Li · Y.
Introduction

Early childhood obesity has become a major public health concern globally. The preschool period (ages 4–6 years) represents a critical window for obesity prevention due to its long-term implications on growth trajectories and behaviour formation. However, existing evidence for effective interventions targeting this age group remains limited and inconsistent, particularly in low- and middle-income countries.

Methods and analysis

The Peking University-Smart Monitoring and Responsive Technology for Early Childhood Health is a cluster-randomised controlled trial designed to evaluate the effectiveness and sustainability of a multi-component, digital health–assisted obesity prevention intervention. The trial involves approximately 980 children aged 4–6 years (middle and senior kindergarten classes) from 14 kindergartens, randomly allocated to either the intervention (n=7) or control (n=7) groups. The intervention spans 9 months, followed by a 12-month post-intervention follow-up. Interventions are delivered across kindergartens, families and healthcare systems. A digital Smart Health Platform is integrated into the intervention to provide health education, real-time feedback and interactive support, enabling personalised health management and promoting parental engagement. Data are collected at baseline, 4, 9 and 21 months. The primary outcome is the between-group difference in changes in body mass index Z-score at 9 months. Secondary outcomes include other anthropometric indicators, dietary intake, physical activity levels and other measurements. In addition, a process evaluation will be conducted to assess fidelity and participant engagement, and a health economic evaluation will estimate cost-effectiveness and cost-benefit outcomes.

Ethics and dissemination

Ethical approval for this study was obtained from the Ethics Committee of the Shandong Maternal and Child Health Hospital (no. 2025-042). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations to inform future childhood obesity prevention policies and practices.

Trial registration number

NCT07117149.

Complementary feeding indicators among children aged 6-23 months: a cross-sectional study assessing minimum dietary diversity, minimum acceptable diet and dietary patterns in Njombe Town Council, Tanzania

Por: Jaffar · S. S. · Peter · D. E. · Ntwenya · J. E. · Ndunguru · F. M.
Objectives

This study assessed the minimum dietary diversity (MDD), minimum meal frequency (MMF), minimum acceptable diet (MAD) and dietary patterns among children aged 6–23 months in Njombe Town Council.

Design

Community-based cross-sectional study.

Setting

This study was conducted in the Njombe Town Council, which is located in the Njombe region in the southern part of Tanzania.

Participants

A total of 330 caregivers of children aged 6–23 months were recruited using a multistage probability sampling technique. Data were collected from January to March 2021 using a structured questionnaire adapted from the Process for Promotion of Child Feeding (ProPAN) manual.

Interventions

None.

Primary and secondary outcome measures

The primary outcomes were the prevalence of MDD, MMF and MAD, assessed according to the 2021 WHO infant and young child feeding indicators. Secondary outcomes included food group consumption and dietary patterns identified using principal component analysis.

Results

A total of 330 caregivers of children aged 6–23 months participated in the current study. Nearly half (43.9%; n=145) were aged between 30 and 49 years, with a mean age of 30.28 years and an SD of ±6.119 years. Only 26.36% of children aged 6–23 months achieved MDD, 71.5% achieved MMF and 18.48% met MAD, with a mean dietary diversity score of 3.35±1.6. Predominant foods included grains, roots and tubers (80.91%) and breast milk (90%), while dairy products were the least consumed (7.27%). Three dietary patterns emerged: cereals, roots and tubers; dairy products and eggs; and vitamin A-rich fruits and vegetables.

Conclusion

The MDD and MAD attainment in Njombe Town Council are suboptimal, reflecting reliance on staple foods and limited nutrient-rich options. These findings highlight the need for context-specific interventions, including strengthened nutrition education, promotion of diversified diets and agricultural strategies that improve access to nutrient-dense foods to enhance infant and young child nutrition.

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