Indira Gandhi Institute of Child Health

Tracheostomy in the pediatric population is a technical and demanding procedure due to the smaller, more pliable trachea and the limited exposure of the operating field. It has been documented to have higher morbidity and mortality, especially among low birth weight and pre-term infants. A review of the existing literature shows that indications, epidemiology, and complications are changing dynamically, and no definite guidelines have been established. A five-year retrospective observational study on pediatric tracheostomy was carried out at a pediatric tertiary care center. All children aged between 1 day and 18 years who had undergone tracheostomy were included. Case records of all children were analyzed meticulously for age, sex, indications, procedure, and complications of tracheostomy. During the study period, 148 children underwent tracheostomy at our pediatric tertiary care center. The most common indication for tracheostomy was neurological causes, noted in 77 patients (52.02%). The most common early postoperative complication was tube obstruction in 13 patients (8.78%), and the most common delayed postoperative complication was suprastomal collapse in 52 patients (35.13%). In total, 104 patients (70.27%) underwent successful decannulation. Pediatric tracheostomy is a very demanding and challenging procedure owing to the alterations in the neck anatomy, variations in the airway, and several associated complications. There is a growing need to know the change in indications, complications, and overall outcome of pediatric tracheostomies for better care and efficient management of children requiring tracheostomies.

Abstract Background: Medical devices are crucial in health care; however, adverse events (AEs) require safety evaluation. Causality assessment determines the contribution of the device to AEs and guides decisions. India lacks a standardized scoring tool, leading to inconsistent interpretation. Aim: This study aimed to develop and validate a reliable causality assessment tool for AEs associated with medical devices. Materials and Methods: A nine-question structured scale was developed from a literature review to classify causality as certain, probable, possible, or unlikely. Validity was established through expert comparisons using the European Union Causality Assessment Scale. Sensitivity, specificity, and area under the curve (AUC) were calculated. Reliability testing occurred in two phases using 50 random Manufacturer and User Facility Device Experience database cases (2014–2024) assessed by six raters (physicians, biomedical engineers, and pharmacists). After 6 weeks, the same cases were reassessed. Reliability was determined using Cronbach’s alpha and intraclass correlation coefficient (ICC). Results: The ICC values for phases 1 and 2 were 0.324 and 0.399, respectively ( P < 0.001), indicating moderate agreement. Validity testing showed a sensitivity of 90.95%, specificity of 83.25%, and AUC of 0.8605, demonstrating strong accuracy in determining causality. The scale demonstrated high reliability (Cronbach’s alpha = 0.893). Conclusion: The validated causality assessment tool enhances consistency and reduces subjectivity among evaluators. It provides a reliable scoring system to support regulatory decisions, improve safety, and enable postmarket surveillance. This tool enables systematic assessment of device-related AEs across healthcare settings.

We report a male neonate, born to consanguineous parents, who presented with respiratory distress and signs of severe intrauterine growth restriction. Clinical findings included bilateral cataracts and left ventricular hypertrophy. Elevated cardiac biomarkers and abnormal fatty acid oxidation metabolites were noted. Despite intensive care, the infant died of cardiac failure at 50 days. Genetic testing revealed a pathogenic frameshift mutation in exon 14 of the AGK gene, confirming Sengers syndrome. This case highlights the importance of early genetic screening in consanguineous families and the need for multidisciplinary management.

Autoimmune hepatitis (AIH) in children presents significant diagnostic and therapeutic challenges requiring a multidisciplinary and evidence-based approach. The Indian Society of Pediatric Gastroenterology, Hepatology, and Nutrition (ISPGHAN) convened a consensus meeting on February 23, 2025, bringing together national and international experts to address key clinical and research questions. The deliberations spanned epidemiology, clinical presentation, diagnosis including autoantibodies, immunoglobulin G (IgG), histology and diagnostic scores, therapeutic strategies, management of difficult-to-treat AIH, long-term monitoring, and special scenarios, such as seronegative AIH (SN-AIH), autoimmune sclerosing cholangitis/overlap syndromes and post-transplant complications like recurrence and de novo-AIH. Recommendations were formulated using standard GRADE system and finalized through structured consensus. These guidelines aim to standardize care, assist clinicians in decision-making, and improve outcomes in children with AIH across diverse healthcare settings.

INTRODUCTION: Tracheostomy is a surgical procedure in which an opening is created between the external environment and trachea bypassing the upper airway. The presence of microorganisms colonizing the tracheobronchial airway of tracheostomised patients can potentially increase the risk of lower respiratory infections, failure of decannulation and poor surgical outcomes. The aim of the present research work was to study the microbiological profile of the tracheal aspirates and its antibiotic sensitivity in paediatric patients who had undergone tracheostomy. MATERIALS & METHODS: The present study was conducted at the department of Otorhinolaryngology at a paediatric tertiary care hospital between August 2023-2024. 59 paediatric tracheostomised patients aged 1 day-18 years were included in the study. Tracheal aspirate obtained during regular tube changes was tested for the presence of microorganisms and their antibiotic sensitivity. RESULTS: Of the 68 patients who underwent tracheostomy tube changes, 59 were included in the present study. 91.53% of the study population tested positive for microbial growth in the tracheal aspirate. Pseudomonas aeruginosa (69.49%) was the most common organism isolated. 10.17% showed methicillin resistant Staphylococcus aureus (MRSA) and were positive for airway granulations. CONCLUSION: Despite the numerous benefits of tracheostomy, the presence of tracheostomy tube in the airway acts as a contributing factor for the colonization of pathogenic bacteria. Presence of biofilm forming microorganisms in the airway can increase the risk of lower respiratory infections, decreased potential for decannulation and increased risk of airway surgical failure.

Scrub typhus and other doxycycline-treatable infections are significant contributors of acute encephalitis syndrome (AES) in India. Limited surveillance in South India has hindered their recognition and the inclusion of doxycycline in treatment protocols. We aimed to systematically investigate infectious aetiologies of AES in children from Karnataka, India, and develop clinical prediction models for diagnosing scrub typhus and guiding clinical decisions for doxycycline therapy. This multicentre, prospective study enrolled children aged >28 days to 18 years with AES presenting to three tertiary care hospitals in Bengaluru, India. Primary outcomes were microbiological diagnosis of AES and clinical prediction models for diagnosing scrub typhus and identifying patients with doxycycline-treatable causes. Models were developed using multivariable logistic regression, internally validated, and simplified into point-scoring systems. Model performance was evaluated using c-statistics, calibration slopes, and calibration-in-the-large, adhering to TRIPOD guidelines. Between February 2020 and February 2023, 714 children were screened, of whom 587 were included. Of these, 315 (54%) had a microbiological diagnosis. Scrub typhus accounted for 138/315 (44%), and doxycycline-treatable causes were diagnosed in 193/315 (61%) of these cases. Key predictors associated with both scrub typhus and doxycycline-treatable causes were age, illness duration, lymphadenopathy, oedema, hepatomegaly, lymphocyte count, platelet count, and serum albumin levels. Adjusted c-statistics were 0.83 (95% CI: 0.78-0.87) for the scrub typhus model and 0.75 (95% CI: 0.7-0.81) for the doxycycline model, with calibration slopes of 0.85 (0.82-0.88) and 0.83 (0.78-0.87), respectively. CITL values were -0.03 (-0.06-0) and 0.05 (0.02-0.09). Points-based scores predicted probabilities ranging from 5% to 99.8% (scrub typhus model) and 20%-99% (doxycycline-treatable model). Scrub typhus was the most common microbiological diagnosis, and most patients had a doxycycline-treatable cause, underscoring the need to prioritise doxycycline in empirical treatment protocols in South India. The models demonstrated strong performance; however external validation is necessary for broader applicability. DBT/Wellcome Trust India Alliance FellowshipIA/CPHE/18/1/503960.

Graphical A small multi-center trial indicated that using a clinical decision support tool, Opt-IVF, to guide follicular-stimulating hormone (FSH) dosing during superovulation increased the number of high-quality embryos in non-PCOS patients treated with an antagonist protocol. This clinical trial aims to study whether Opt-IVF improves clinical pregnancy rates across all patient types and protocols without any exceptions. 402 women aged 25–45 undergoing in vitro fertilization (IVF) were enrolled in the trial. Half (201 women) were randomly assigned to the intervention group (Opt-IVF) to guide FSH dosing and determine the antagonist and trigger days. The other half was assigned to the control group (conventional treatment). The participants in the intervention group required significantly lower cumulative FSH doses during their controlled ovarian stimulation cycles. This group also had a higher number of M2 oocytes retrieved compared to the control group. Furthermore, the intervention group produced a significantly higher number of embryos and good-quality blastocysts, leading to increased pregnancy rates compared to the control group. We conclude that using the Opt-IVF clinical decision support tool led to numerous benefits, such as reducing the need for ultrasound examinations after day 5, lowering the required FSH dosage, and achieving a higher number of high-quality blastocysts and increased pregnancy rates. Thus, Opt-IVF offers a personalized, optimized, and simplified approach to superovulation.Lay summaryIVF involves four main steps: stimulating the ovaries to produce multiple eggs (superovulation), retrieving the eggs, fertilizing them in a lab, and transferring the resulting embryos into the uterus. Despite being available worldwide, IVF remains costly in both wealthy and low-income countries. The high expenses are driven by expensive medications, infrastructure costs, extensive testing, and labor costs for healthcare professionals. Of the four steps, superovulation is the most expensive due to the need for frequent monitoring through ultrasounds and blood tests. A woman’s body normally releases just one monthly egg. But for IVF to work better, doctors give the woman daily hormones to help her body grow and release many eggs at once. This is superovulation. This stage is an important stage in IVF and influences the outcomes of the IVF to a large extent. Physicians determine the daily dosage of hormones based on general guidelines, observational data, and their clinical experience, but this dosage is not tailored for each individual, which can sometimes lead to overstimulation. The cost of drugs and testing makes this stage particularly expensive. To address these challenges, we developed a decision support tool called Opt-IVF, designed to provide a personalized and optimized dosage profile for each patient. The results of the trial show that Opt-IVF tailors the dosage to the individual, reduces the need for testing, and improves outcomes for patients.Trial registrationClinicalTrials.gov (ID – NCT05981898).Date of registrationJuly 31 15, 2023. Date of enrollment for the first subject: September 15, 2023.

BackgroundAcute pulmonary edema (APE) is a rare complication of subarachnoid hemorrhage (SAH) that is associated with increased morbidity and poor clinical outcomes. There is limited literature addressing the incidence and risk factors of this complication, highlighting the need for further investigation as undertaken in the present study.MethodsThe 2016 to 2021 National Inpatient Sample (NIS) was used to identify adult inpatients with a primary diagnosis of non-traumatic SAH. Univariate and multivariable analyses adjusting for patient demographics, and comorbidity status, were used to characterize statistical associations with APE.ResultsA total of 42,141 patients were identified as having SAH from 2016 to 2021. Of these patients, 960 patients (2.3%) were found to have APE. APE was associated with increased length of stay (20.0 ± 18.9 days vs. 11.6 ± 14.3, p < 0.001), increased total costs ($503,671.3 ± 647,729.9 vs. $238,724.6 ± 328,062.1, p < 0.001), increased number of days from admission to first procedure (3.5 ± 7.3 vs. 1.9 ± 4.9, p < 0.001), increased Elixhauser comorbidity index ≥ 3 (77.5% vs. 66.0%, p < 0.001), and increased mortality (40.2% vs. 22.5%, p < 0.001). After controlling for confounding factors, independent risk factors for APE in patients with non-traumatic SAH included: Coagulopathies (adjusted Odds Ratio [aOR]: 1.57, 95% confidence interval [CI] 1.31–1.89, p < 0.001), Fluid and Electrolyte Disorders (aOR: 2.54, CI 2.13–3.03, p < 0.001), Liver Disease (aOR: 1.37, CI 1.07–1.76, p = 0.013), Obesity (aOR: 1.47, CI 1.19–1.81, p = 0.003), Pulmonary Circulatory Disorder (aOR: 1.72, CI 1.31–2.26, p = 0.001), and Weight Loss (aOR: 1.67, CI 1.36–2.04, p < 0.001).ConclusionAPE after SAH is associated with increased complicated hospital course. Neurosurgeons and Neurocritical care medical professionals should be aware of the comorbidities and factors associated with increased APE after SAH to improve patient outcomes.