Non-inferiority randomized controlled trial comparing CricOid pressure and para-laryngeal pressure in parturients undergoing cesarean delivery: NiCOP trial.

BACKGROUND: Cricoid pressure has been surrounded with controversies regarding its effectiveness. Application of ultrasound-guided para-laryngeal (PL) force has been shown to occlude the esophagus effectively compared with cricoid pressure (CP) in awake patients. We hypothesized that there would be no meaningful difference in the change in antero-posterior esophageal diameter from with application of cricoid or para-laryngeal pressure in parturients undergoing cesarean delivery under general anesthesia. METHODS: In this prospective, randomized, non-inferiority trial, 40 parturients scheduled for elective cesarean delivery under general anesthesia were randomized to receive rapid sequence induction with either cricoid pressure (n = 20) or para-laryngeal pressure (n = 20). The antero-posterior diameter of the esophagus, measured by sonography, was the primary outcome. Visualization of the esophagus, its position in relation to the glottic aperture, esophageal occlusion, percentage of glottic opening (POGO), time to intubation, first pass success rate, overall success rate and adverse events like desaturation or bronchospasm were secondary outcomes. RESULTS: The mean change in anterior-posterior diameter in the CP group was 0.17 ±0.1 cm vs. 0.28 ±0.1 cm in the PL group. The mean difference (CP-para-laryngeal pressure) between the groups was -0.11 (95% CI -0.17 to -0.1) cm. As the upper limit of the 95% CI was lower than the prespecified non-inferiority margin (δ = -0.2), non-inferiority was established (P <0.001]. There was no significant difference in the POGO score (P = 0.818), time to intubation (P =0.55), or intubation attempts (P = 0.99). CONCLUSIONS: Para-laryngeal pressure was non-inferior to CP in occluding the esophagus in parturients undergoing cesarean delivery under general anesthesia and furthermore, no significant deterioration in intubation parameters was seen.

Prevalence and antimicrobial resistance of food safety related Vibrio species in inland saline water shrimp culture farms / Prevalencia y resistencia a los antimicrobianos de especies de Vibrio relacionadas con la inocuidad de los alimentos en granjas de cultivo de camarones de aguas saladas continentales

This study evaluated the potential pathogenicity and antimicrobial resistance (AMR) of Vibrio species isolated from inland saline shrimp culture farms. Out of 200 Vibrio isolates obtained from 166 shrimp/water samples, 105 isolates were identified as V. parahaemolyticus and 31 isolates were identified as V. alginolyticus and V. cholerae, respectively. During PCR screening of virulence-associated genes, the presence of the tlh gene was confirmed in 70 and 19 isolates of V. parahaemolyticus and V. alginolyticus, respectively. Besides, 10 isolates of V. parahaemolyticus were also found positive for trh gene. During antibiotic susceptibility testing (AST), very high resistance to cefotaxime (93.0%), amoxiclav (90.3%), ampicillin (88.2%), and ceftazidime (73.7%) was observed in all Vibrio species. Multiple antibiotic resistance (MAR) index values of Vibrio isolates ranged from 0.00 to 0.75, with 90.1% of isolates showing resistance to ≥ 3 antibiotics. The AST and MAR patterns did not significantly vary sample-wise or Vibrio species-wise. During the minimum inhibitory concentration (MIC) testing of various antibiotics against Vibrio isolates, the highest MIC values were recorded for amoxiclav followed by kanamycin. These results indicated that multi-drug resistant Vibrio species could act as the reservoirs of antibiotic resistance genes in the shrimp culture environment. The limited host range of 12 previously isolated V. parahaemolyticus phages against V. parahaemolyticus isolates from this study indicated that multiple strains of V. parahaemolyticus were prevalent in inland saline shrimp culture farms. The findings of the current study emphasize that routine monitoring of emerging aquaculture areas is critical for AMR pathogen risk assessment.(AU)

Prolonged voluntary wheel running reveals unique adaptations in mdx mice treated with microdystrophin constructs ± the nNOS-binding site.

We tested the effects of prolonged voluntary wheel running on the muscle function of mdx mice treated with one of two different microdystrophin constructs. At 7 weeks of age mdx mice were injected with a single dose of AAV9-CK8-microdystrophin with (gene therapy 1, GT1) or without (gene therapy 2, GT2) the nNOS-binding domain and were assigned to one of four gene therapy treated groups: mdxRGT1 (run, GT1), mdxGT1 (no run, GT1), or mdxRGT2 (run,GT2), mdxGT2 (no run, GT2). There were two mdx untreated groups injected with excipient: mdxR (run, no gene therapy) and mdx (no run, no gene therapy). A third no treatment group, Wildtype (WT) received no injection and did not run. mdxRGT1, mdxRGT2 and mdxR performed voluntary wheel running for 52 weeks; WT and remaining mdx groups were cage active. Robust expression of microdystrophin occurred in diaphragm, quadriceps, and heart muscles of all treated mice. Dystrophic muscle pathology was high in diaphragms of non-treated mdx and mdxR mice and improved in all treated groups. Endurance capacity was rescued by both voluntary wheel running and gene therapy alone, but their combination was most beneficial. All treated groups increased in vivo plantarflexor torque over both mdx and mdxR mice. mdx and mdxR mice displayed ∼3-fold lower diaphragm force and power compared to WT values. Treated groups demonstrated partial improvements in diaphragm force and power, with mdxRGT2 mice experiencing the greatest improvement at ∼60% of WT values. Evaluation of oxidative red quadriceps fibers revealed the greatest improvements in mitochondrial respiration in mdxRGT1 mice, reaching WT levels. Interestingly, mdxGT2 mice displayed diaphragm mitochondrial respiration values similar to WT but mdxRGT2 animals showed relative decreases compared to the no run group. Collectively, these data demonstrate that either microdystrophin construct combined with voluntary wheel running increased in vivo maximal muscle strength, power, and endurance. However, these data also highlighted important differences between the two microdystrophin constructs. GT1, with the nNOS-binding site, improved more markers of exercise-driven adaptations in metabolic enzyme activity of limb muscles, while GT2, without the nNOS-binding site, demonstrated greater protection of diaphragm strength after chronic voluntary endurance exercise but decreased mitochondrial respiration in the context of running.

Genotypic capacity of post-anthesis stem reserve mobilization in wheat for yield sustainability under drought and heat stress in the subtropical region.

Wheat productivity is severely affected by drought and heat stress conditions worldwide. Currently, stem reserve mobilization (SRM) is receiving increased attention as a trait that can sustain wheat yields under adverse environments. However, the significance of SRM in sustaining wheat yields under drought and heat stress conditions remains uncertain in the tropical climate of Indo-Gangetic Plain region. Therefore, this study aimed to investigate genotypic variations in SRM in wheat and their influence on yield sustainability under drought and heat stress environments. The experiment was designed in an alpha-lattice layout, accommodating 43 genotypes under four simulated environments [timely sown and well irrigated (non-stress); timely sown and water-deficit/drought stress; late-sown and well-irrigated crop facing terminally high temperature; and late-sown and water-deficit stress (both water-deficit and heat stress)]. The water-deficit stress significantly increased SRM (16%-68%, p < 0.01) compared to the non-stress environment, while the heat stress conditions reduced SRM (12%-18%). Both SRM and stem reserve mobilization efficiency exhibited positive correlations with grain weight (grain weight spike-1) under all three different stress treatments (p < 0.05). Strong positive correlations between stem weight (at 12 days after anthesis) and grain weight were observed across the environments (p < 0.001); however, a significant positive correlation between stem weight and SRM was observed only with stress treatments. Results revealed that the SRM trait could effectively alleviate the impacts of water-deficit stress on yields. However, the SRM-mediated yield protection was uncertain under heat stress and combined water-deficit and heat stress treatments, possibly due to sink inefficiencies caused by high temperature during the reproductive period. Defoliated plants exhibited higher SRM than non-defoliated plants, with the highest increment observed in the non-stress treatment compared to all the stress treatments. Results revealed that wider genetic variability exists for the SRM trait, which could be used to improve wheat yield under drought stress conditions.

Detection of antimicrobial resistance genes in extended spectrum beta-lactamase-producing Escherichia coli from milk of indigenous Beetal goats of Punjab.

Background: Antimicrobial resistance (AMR) is a burning issue in the present era. Mastitis in dairy animals is one of the most important causes of huge production loss to dairy farmers. Aims: The study aims to find the prevalence, antimicrobial resistance profile, and resistance genes in the extended-spectrum beta-lactamase-producing Escherichia coli in mastitic milk. Methods: A total of 125 milk samples were collected from Beetal goats suffering from clinical mastitis from different districts of Punjab and processed for bacterial isolation and further identification. The drug resistance profile of ESBL-producing E. coli and its associations with molecular markers was analyzed using statistical analysis. Results: The prevalence of ESBL-producing E. coli in dairy goats of Punjab was recorded as 6.4%. The isolates showed the highest resistance to the beta-lactam group of antibiotics. The resistance percentages of streptomycin, gentamicin, tetracycline, chloramphenicol, clotrimazole, and colistin were 50%, 37.5%, 50%, 25%, 25%, and 50%, respectively. The isolates showed intermediate resistance to imipenem (12.5%) and tetracycline (25%). The ESBL-producing E. coli isolates harbored the resistance genes blaCTXM (100%), blaTEM (62.5%), blaSHV (25%), blaOXA (37.5%), tetA (37.5%), tetB (25%), aadA (37.5%), sul1 (25%), MOXM (12.5%), DHAM (25%), and blaCMY-2 (50%). Tetracycline and sulphonamide resistances were statistically associated with their respective resistance genes (P<0.05). Streptomycin resistance was not statistically associated with the presence of the aadA gene (P>0.05). The genes blaIMP and blaNDM were not recorded in any of the isolates. In this study, 12.5% of the isolates showed co-resistance to colistin and carbapenem. Conclusion: Antimicrobial resistance is a hot topic and requires immediate attention.

Study Protocol of the Bladder Adjuvant RadioTherapy (BART) Trial: A Randomised Phase III Trial of Adjuvant Radiotherapy Following Cystectomy in Bladder Cancer.

AIMS: To assess the efficacy and safety of adjuvant radiotherapy in patients with high-risk muscle-invasive bladder cancer (MIBC) following radical cystectomy (RC) and chemotherapy. MATERIALS AND METHODS: The BART (Bladder Adjuvant RadioTherapy) trial is an ongoing multicentric, randomised, phase III trial comparing the efficacy and safety of adjuvant radiotherapy versus observation in patients with high-risk MIBC. The key eligibility criteria include ≥pT3, node-positive (pN+), positive margins and/or nodal yield <10, or, neoadjuvant chemotherapy for cT3/T4/N+ disease. In total, 153 patients will be accrued and randomised, in a 1:1 ratio, to either observation (standard arm) or adjuvant radiotherapy (test arm) following surgery and chemotherapy. Stratification parameters include nodal status (N+ versus N0) and chemotherapy (neoadjuvant chemotherapy versus adjuvant chemotherapy versus no chemotherapy). For patients in the test arm, adjuvant radiotherapy to cystectomy bed and pelvic nodes is planned with intensity-modulated radiotherapy to a dose of 50.4 Gy in 28 fractions using daily image guidance. All patients will follow-up with 3-monthly clinical review and urine cytology for 2 years and subsequently 6 monthly until 5 years, with contrast-enhanced computed tomography abdomen pelvis 6 monthly for 2 years and annually until 5 years. Physician-scored toxicity using Common Terminology Criteria for Adverse Events version 5.0 and patient-reported quality of life using the Functional Assessment of Cancer Therapy - Colorectal questionnaire is recorded pre-treatment and at follow-up. ENDPOINTS AND STATISTICS: The primary endpoint is 2-year locoregional recurrence-free survival. The sample size calculation was based on the estimated improvement in 2-year locoregional recurrence-free survival from 70% in the standard arm to 85% in the test arm (hazard ratio 0.45) using 80% statistical power and a two-sided alpha error of 0.05. Secondary endpoints include disease-free survival, overall survival, acute and late toxicity, patterns of failure and quality of life. CONCLUSION: The BART trial aims to evaluate whether contemporary radiotherapy after standard-of-care surgery and chemotherapy reduces pelvic recurrences safely and also potentially affects survival in high-risk MIBC.

Characterizing the metabolomic signature of attention-deficit hyperactivity disorder in twins.

Emerging evidence implicate the gut microbiota as a potential susceptibility factor in attention-deficit hyperactivity disorder (ADHD), a common multifactorial neurodevelopmental condition. However, little is known about the biochemical signature of ADHD, including the metabolic contribution of the microbiota via the gut-brain axis, and the relative contribution of genetics and environmental factors. Here, we perform unbiased metabolomic profiling of urine and fecal samples collected from a well-characterized Swedish twin cohort enriched for ADHD (33 ADHD, 79 non-ADHD), using 1H nuclear magnetic resonance spectroscopy and liquid chromatography-mass spectrometry. Our results highlight sex-specific patterns in the metabolic phenotype of individuals with ADHD. Specifically, the urine profile of males, but not females, with ADHD was characterized by greater excretion of hippurate, a product of microbial-host co-metabolism that can cross the blood-brain-barrier with bioactivity of potential relevance to ADHD. This trans-genomic metabolite was also negatively correlated with IQ in males and was significantly correlated with fecal metabolites associated with gut microbial metabolism. The fecal profile of ADHD individuals was characterized by increased excretion of stearoyl-linoleoyl-glycerol, 3,7-dimethylurate, and FAD and lower amounts of glycerol 3-phosphate, thymine, 2(1H)-quinolinone, aspartate, xanthine, hypoxanthine, and orotate. These changes were independent of ADHD medication, age, and BMI. Furthermore, our specific twins' models revealed that many of these gut metabolites had a stronger genetic influence than environmental. These findings suggest that metabolic disturbances in ADHD, involving combined gut microbial and host metabolic processes, may largely derive from gene variants previously linked to behavioral symptoms in this disorder. This article is part of the Special Issue on "Microbiome & the Brain: Mechanisms & Maladies".

Prevalence and antimicrobial resistance of food safety related Vibrio species in inland saline water shrimp culture farms.

This study evaluated the potential pathogenicity and antimicrobial resistance (AMR) of Vibrio species isolated from inland saline shrimp culture farms. Out of 200 Vibrio isolates obtained from 166 shrimp/water samples, 105 isolates were identified as V. parahaemolyticus and 31 isolates were identified as V. alginolyticus and V. cholerae, respectively. During PCR screening of virulence-associated genes, the presence of the tlh gene was confirmed in 70 and 19 isolates of V. parahaemolyticus and V. alginolyticus, respectively. Besides, 10 isolates of V. parahaemolyticus were also found positive for trh gene. During antibiotic susceptibility testing (AST), very high resistance to cefotaxime (93.0%), amoxiclav (90.3%), ampicillin (88.2%), and ceftazidime (73.7%) was observed in all Vibrio species. Multiple antibiotic resistance (MAR) index values of Vibrio isolates ranged from 0.00 to 0.75, with 90.1% of isolates showing resistance to ≥ 3 antibiotics. The AST and MAR patterns did not significantly vary sample-wise or Vibrio species-wise. During the minimum inhibitory concentration (MIC) testing of various antibiotics against Vibrio isolates, the highest MIC values were recorded for amoxiclav followed by kanamycin. These results indicated that multi-drug resistant Vibrio species could act as the reservoirs of antibiotic resistance genes in the shrimp culture environment. The limited host range of 12 previously isolated V. parahaemolyticus phages against V. parahaemolyticus isolates from this study indicated that multiple strains of V. parahaemolyticus were prevalent in inland saline shrimp culture farms. The findings of the current study emphasize that routine monitoring of emerging aquaculture areas is critical for AMR pathogen risk assessment.

Population Impact of Sugar-Sweetened Beverages on Dental Caries and Overweight/Obesity in Australian Children.

KNOWLEDGE TRANSFER STATEMENT: The reported findings greatly consolidated evidence of detrimental effects of sugars intake on child oral health and overweight and obesity, some of the most prevalent chronic conditions in children. Evidence on population impact of sugars intake is directly informative to policy makers and the public about the potential impact of population-based programs targeting sugars intake to prevent dental caries and overweight and obesity.

Proton beam radiotherapy for choroidal and ciliary body melanoma in the UK-national audit of referral patterns of 1084 cases.

INTRODUCTION: Proton beam therapy has been utilised for the treatment of uveal melanoma in the UK for over 30 years, undertaken under a single centre. In the UK, all ocular tumours are treated at one of four centres. We aimed to understand the variation in referral patterns to the UK proton service, capturing all uveal melanoma patients treated with this modality. METHODS: Retrospective analysis of data regarding all patients treated at the Clatterbridge Proton service between January 2004 and December 2014. RESULTS: A total of 1084 patients with uveal melanoma were treated. The mean age was 57 years (range 9-90 years), basal diameter of 11.5 mm (range 2.0-23.4 mm) and tumour thickness of 3.9 mm (range 0.1-15.4 mm). The majority were TNM stage I (39%) or II (36%). The distance to the optic nerve varied from 0 to 24.5 mm with 148 (14%) of patients having ciliary body involvement. There were variations in the phenotypic characteristic of the tumours treated with protons from different centres, with London referring predominantly small tumours at the posterior pole, Glasgow referring large tumours often at the ciliary body and Liverpool sending a mix of these groups. DISCUSSION: In the UK, common indications for the use of proton treatment in uveal melanoma include small tumours in the posterior pole poorly accessible for plaque treatment (adjacent to the disc), tumours at the posterior pole affecting the fovea and large anterior tumours traditionally too large for brachytherapy. This is the first UK-wide audit enabling the capture of all patients treated at the single proton centre.

Patterns of neck metastasis and occult neck disease during recurrent laryngeal cancer.

OBJECTIVE: Numerous factors are considered to impact on the rate of complications during salvage total laryngectomy procedures. Neck dissection could be one of these factors. This study analysed the pattern of lymph node metastasis and rate of occult neck disease during salvage total laryngectomy as well as the impact of neck dissection on survival and complication rates. METHOD: This was a retrospective analysis of a prospectively maintained laryngectomy database in two large tertiary teaching hospitals. RESULTS: The rate of occult neck disease was 11.1 per cent. Most cases with occult neck disease had rT4 disease. Patients with complications, advanced tumour stage and positive margins had a significant decrease in overall survival. Patients receiving elective neck dissection did not have any survival benefit. Positron emission tomography-computed tomography showed a very high specificity and negative predictive value. CONCLUSION: According to the low risk of occult neck disease when using contemporary imaging techniques as well as the lack of impact on survival, conservative management of the neck should be considered for crT1-T3 recurrence.

Complete genome sequencing and characterization of single-stranded DNA Vibrio parahaemolyticus phage from inland saline aquaculture environment.

Despite their evolutionary, molecular biology and biotechnological significance, relatively fewer numbers of single-stranded DNA (ssDNA) filamentous phages belonging to the family Inoviridae have been discovered and characterized to date. The present study focused on genome sequencing and characterization of an ssDNA Vibrio parahaemolyticus phage V5 previously isolated from an inland saline shrimp culture farm. The complete circular genome of phage V5 consisted of 6658 bp with GC content of 43.7%. During BLASTn analysis, only 36% of phage V5 genome matched with other Vibrio phage genomes in the NCBI database with a sequence identity value of 79%. During the phylogenetic analysis, phage V5 formed a separate branch in the minor clade. These features indicate the novel nature of the phage V5 genome. Among 10 predicted open reading frames (ORFs) in the phage V5 genome, 6 encoded for the proteins of known biological functions, whereas the rest were classified as hypotheticals. Proteins involved in replication and structural assembly were encoded by the phage genome. However, the absence of genes encoding for DNA/RNA polymerases and tRNAs signified that phage V5 is dependent on the host`s molecular machinery for its propagation. As per our knowledge, this is the first study describing the novel genome sequence of an ssDNA V. parahaemolyticus phage from the inland saline environment.

Establishing and integrating a transoral robotic surgery programme into routine oncological management of head and neck cancer - a UK perspective.

BACKGROUND: The introduction of transoral robotic surgery into routine management of patients is complex. It involves organisational, logistical and clinical challenges. This study presents our experience of implementing such a programme and provides a blueprint for other centres willing to establish similar services. METHODS: Implementation of the robotic surgery programme focused on several key domains: training, logistics, governance, multidisciplinary team awareness, pre-operative imaging, anaesthesia, post-operative care, finance, patient selection and consent. Programme outcomes were evaluated by assessing operative outcomes of the first 117 procedures performed. RESULTS: The success of the transoral robotic surgery programme has been possible because of the scrupulous planning phase before the first procedure, and the time invested on team awareness and training. CONCLUSION: Implementation of a new transoral robotic surgery service has led to: the development of a dedicated transoral robotic surgery patient care protocol, the performance of progressively more complex procedures, the inclusion of transoral robotic surgery training and the establishment of several research projects.

Validation of an obstetric quality of recovery scoring tool (ObsQoR-11) after elective caesarean delivery in a developing country: a prospective observational study.

BACKGROUND: The obstetric quality of recovery scoring tool (ObsQoR-11) was developed and validated in the United Kingdom for use after elective and emergency caesarean delivery. Quality of recovery scoring tools validated in one country may not be valid in other countries with significant cultural, socio-economic and linguistic variations. The aim of the current study was to validate a Hindi version of the ObsQoR-11. METHODS: In this prospective observational study, 100 parturients who underwent elective caesarean delivery in a tertiary care obstetric referral university hospital in North India were asked to complete a Hindi version of the ObsQoR-11 scoring tool 24 h after surgery. The performance of the Hindi version of ObsQoR-11 was assessed using measures of validity, reliability, and feasibility. RESULTS: The Hindi version of ObsQoR-11 correlated moderately with the global health visual analogue scale (r=0.45, 95% CI 0.27 to 0.59; P <0.0001) and discriminated well between good and poor recovery (mean (SD) score 84.6 (9.4) vs 75.0 (11.2); P <0.0001). The reliability and internal consistency were moderate (Cronbach's alpha=0.66; Spearman-Brown Prophesy Reliability estimate=0.57) with good repeatability (intraclass correlation coefficient 0.85, 95% CI 0.69 to 0.93; P <0.0001) and no floor or ceiling effects. All parturients completed the questionnaire in a (median (IQR) time of completion of 3 (1.5 - 5.5) min). CONCLUSION: The Hindi version of the ObsQoR-11 questionnaire is a promising scoring tool to evaluate quality of recovery after elective caesarean delivery. Further research is needed to evaluate the Hindi tool in other institutions in India as well as in other languages.

Antibiotic sensitivity patterns in Staphylococcus spp. isolated from goat milk in association with molecular detection of antibiotic resistance genes.

BACKGROUND: Microbes become unresponsive to the drugs used to treat infections due to their ability to acquire antimicrobial resistance. AIMS: The present research aimed to study the patterns of phenotypic and genotypic antimicrobial resistance in Staphylococcus spp. isolated from goat milk. METHODS: A total of 200 milk samples were collected to isolate Staphylococcus spp. from mastitic and healthy goats from Punjab state, India. The isolates were then identified biochemically and molecularly (polymerase chain reaction (PCR)). An antibiotic sensitivity test was conducted using 15 different antibiotics. Molecular detection of antibiotic resistance genes was done using PCR. Chi-square test was done to study the association between genotypic and phenotypic resistance patterns among the isolates. RESULTS: A total of 47 Staphylococcus spp. were isolated of which 33 and 14 isolates were respectively coagulase positive and negative. The isolates phenotypically showed the highest resistance to Penicillin G (P) (91.4%). Methicillin resistant Staphylococcus aureus (MRSA) was found 56.25%. Amongst the antibiotic resistance genes, tetK (87.23%) was the most prevalent isolated gene followed by blaZ (85.10%), mecA (48.93%), and tetM (14.89%). Statistical analysis revealed that the genotypic and phenotypic resistance patterns were significantly associated with penicillin and methicillin (MET) resistances. CONCLUSION: The high prevalence of antibiotic-resistant Staphylococcus spp., especially MRSA, in goat milk is of concern and needs to be addressed in this area.

"Watch Me Grow- Electronic (WMG-E)" surveillance approach to identify and address child development, parental mental health, and psychosocial needs: study protocol.

BACKGROUND: The COVID-19 pandemic and the associated economic recession has increased parental psychosocial stress and mental health challenges. This has adversely impacted child development and wellbeing, particularly for children from priority populations (culturally and linguistically diverse (CALD) and rural/regional communities) who are at an already increased risk of health inequality. The increased mental health and psychosocial needs were compounded by the closure of in-person preventive and health promotion programs resulting in health organisations embracing technology and online services. Watch Me Grow- Electronic (WMG-E) - developmental surveillance platform- exemplifies one such service. WMG-E was developed to monitor child development and guide parents towards more detailed assessments when risk is identified. This Randomised Controlled Trial (RCT) aims to expand WMG-E as a digital navigation tool by also incorporating parents' mental health and psychosocial needs. Children and families needing additional assessments and supports will be electronically directed to relevant resources in the 'care-as-usual' group. In contrast, the intervention group will receive continuity of care, with additional in-person assessment and 'warm hand over' by a 'service navigator' to ensure their needs are met. METHODS: Using an RCT we will determine: (1) parental engagement with developmental surveillance; (2) access to services for those with mental health and social care needs; and (3) uptake of service recommendations. Three hundred parents/carers of children aged 6 months to 3 years (recruited from a culturally diverse, or rural/regional site) will be randomly allocated to the 'care-as-usual' or 'intervention' group. A mixed methods implementation evaluation will be completed, with semi-structured interviews to ascertain the acceptability, feasibility and impact of the WMG-E platform and service navigator. CONCLUSIONS: Using WMG-E is expected to: normalise and de-stigmatise mental health and psychosocial screening; increase parental engagement and service use; and result in the early identification and management of child developmental needs, parental mental health, and family psychosocial needs. If effective, digital solutions such as WMG-E to engage and empower parents alongside a service navigator for vulnerable families needing additional support, will have significant practice and policy implications in the pandemic/post pandemic period. TRIAL REGISTRATION: The trial (Protocol No. 1.0, Version 3.1) was registered with ANZCTR (registration number: ACTRN12621000766819 ) on July 21st, 2021 and reporting of the trial results will be according to recommendations in the CONSORT Statement.