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Introduction: Gestational trophoblastic neoplasia (GTN) is a group of interrelated lesions that results from abnormal proliferation of placental trophoblastic cells. Early diagnosis and treatment of GTN results in successful outcomes with fertility preservation.This study was intended to stratify GTN cases using WHO scoring system, to diagnose and manage cases as per protocol and to identify complications of treatment of GTN. Methodology: This was a single center prospective observational study conducted at Medical college Kolkata from June 2017 to December 2018. All the diagnosed cases of GTN fulfilling the inclusion criteria were incorporated in the study, data were collected from history, clinical examination and investigations. All the data were tabulated and analyzed by standard statistical methods Results: In this study, primiparous are more prone to have GTN and molar pregnancy was the commonest antecedent event (71.4% of cases). 74.3% (26 out of 35) patients developed disease within four months of previous pregnancy. Anemia and vaginal bleeding were the presenting symptoms in >48.0% cases whereas hemoperitoneum,seizure, hemoptysis and respiratory distress were the rare presenting symptoms.In this study, the cases were diagnosed by histopathology or serial estimation of serum β-hcg. In our study, 91.4% patients were successfully treated with methotrexate and only three cases received EMACO. Conclusion: To conclude this study established that cases of GTN can be successfully treated by early diagnosis and timely management.

Rotavirus is the leading cause of severe dehydrating gastroenteritis among children younger than 5 years in low-income and middle-income countries. Two vaccines-Rotavac and Rotasiil-are used in routine immunisation in India. The safety and immunogenicity of these vaccines administered in a mixed regimen is not documented. We therefore aimed to compare the safety and seroresponse of recipients of a mixed regimen versus a single regimen.We did a multicentre, open-label, randomised, controlled, phase 4, non-inferiority trial at two sites in India. We recruited healthy infants aged 6-8 weeks. Infants with systemic disorders, weight-for-height Z scores of less than minus three SDs, or a history of persistent diarrhoea were excluded. Eligible infants were randomly allocated to six groups in equal numbers to receive either the single vaccine regimen (ie, Rotavac-Rotavac-Rotavac [group 1] or Rotasiil-Rotasiil-Rotasiil [group 2]) or the mixed vaccine regimen (ie, Rotavac-Rotasiil-Rotavac [group 3], Rotasiil-Rotavac-Rotasiil [group 4], Rotavac-Rotasiil-Rotasiil [group 5], or Rotasiil-Rotavac-Rotavac [group 6]). Randomisation was done using an online software by site in blocks of at least 12. The primary outcome was seroresponse to rotavirus vaccine, measured using rotavirus-specific serum IgA antibodies 4 weeks after the third dose. The seroresponse rates were compared between recipients of the four mixed vaccine regimens (consisting of various combinations of Rotavac and Rotasiil) with recipients of the single vaccine regimens (consisting of Rotavac or Rotasiil only for all three doses). The non-inferiority margin was set at 10%. Safety follow-ups were done for the duration of study participation. This trial was registered with the Clinical Trials Registry India, number CTRI/2018/08/015317.Between March 25, 2019, and Jan 15, 2020, a total of 1979 eligible infants were randomly assigned to receive a single vaccine regimen (n=659; 329 in group 1 and 330 in group 2) or a mixed vaccine regimen (n=1320; 329 each in groups 3 and 4, and 331 each in groups 5 and 6). All eligible participants received the first dose, 1925 (97·3%) of 1979 received the second dose, and 1894 (95·7%) received all three doses of vaccine. 1852 (93·6%) of 1979 participants completed the follow-up. The immunogenicity analysis consisted of 1839 infants (1238 [67·3%] in the mixed vaccine regimen and 601 [32·7%] in the single vaccine regimen; 13 samples were insufficient in quantity) who completed vaccination and provided post-vaccination sera. The seroresponse rate in the mixed vaccine regimen group (33·5% [95% CI 30·9-36·2]) was non-inferior compared with the single vaccine regimen group (29·6% [26·1-33·4]); the seroresponse rate difference was 3·9% (95% CI -0·7 to 8·3). The proportion of participants with any type of solicited adverse events was 90·9% (95% CI 88·4-93·0) in the single vaccine regimen group and 91·1% (89·5-92·6) in the mixed vaccine regimen group. No vaccine-related serious adverse events or intussusception were reported during the study.Rotavac and Rotasiil can be safely used in an interchangeable manner for routine immunisation since the seroresponse was non-inferior in the mixed vaccine regimen compared with the single vaccine regimen. These results allow for flexibility in administering the vaccines, helping to overcome vaccine shortages and supply chain issues, and targeting migrant populations easily.Ministry of Health and Family Welfare, Government of India.For the Hindi translation of the abstract see Supplementary Materials section.

Dengue fever is a self-limiting, acute febrile illness caused by an arbovirus. This infection may be asymptomatic or symptomatic with its potential life-threatening form as DHF/DSS. Severe dengue cases occur typically in children due to overproduction of proinflammatory and anti-inflammatory cytokines (called cytokines storm) as well as increased microvascular permeability in them. This study aimed to find circulating dengue serotype and their clinicopathological association among pediatric patients admitted to tertiary care hospitals in Kolkata, India. Overall, 210 patients were approached, among them, 170 dengue suspected children admitted to three tertiary care hospitals were included in this study. Dengue samples were screened for the presence of dengue NS1 antigen and IgM antibodies by enzyme-linked immunosorbent assay. Viral RNA was extracted from NS1 seropositive serum samples and subjected to molecular serotyping by semi-nested reverse-transcription polymerase chain reaction. All patients were followed up for clinical manifestations and biochemical parameters associated with dengue. Cocirculation of all four serotypes was observed and DENV2 was the major circulating strain. Physiological classification of associated clinical symptoms was done as per WHO guideline and represented as a percentage variable. A multivariate logistic regression approach was used for making a regression model including dengue-associated clinical symptoms with dengue positivity or negativity as dependent variables. Thrombocytopenia was observed in 69% of patients and the commonest bleeding manifestation was petechia. Liver function profiles of infected patients were observed during follow-up and represented using a box plot. A significant change in trends of dengue-associated clinical manifestations and differential expression of liver functional profile with different phases of transition of dengue fever was observed in this study population.

AIM Enterotoxigenic Escherichia coli (ETEC) is one of the most widely recognized diarrhoeal pathogens in developing countries. The advancement of ETEC vaccine development depends on the antigenic determinants of the ETEC isolates from a particular geographical region. So, the aim here was to comprehend the distribution of virulence determinants of the clinical ETEC strains of this region. Additionally, an attempt was made to find any correlation with the antimicrobial response pattern. METHODS AND RESULTS Multiplex PCR was employed to identify virulence determinants followed by confirmatory singleplex PCR. For observation of antibiotic response, the Kirby-Bauer method was used. Out of 379 strains, 46% of strains harboured both the enterotoxins ST and LT, whereas 15% were LT only. Among the major colonization factors (CFs), CS6 (41%) was the most prevalent followed by CFA/I (35%) and CFA/III was the lowest (3%). Among the minor CFs, CS21 (25%) was most prevalent, while CS15 showed the lowest (3%) presence. Among the non-classical virulence factors, EatA (69%) was predominant. ETEC strains harbouring CS6 showed resistance towards the commonly used drug Ciprofloxacin (70%). CONCLUSION CS6 and elt+est toxin genes co-occurred covering 51% of the isolates. CS21 was found in most strains with est genes (43%). EatA was found to occur frequently when ST was present alone or with LT. CS6-harbouring strains showed an independent correlation to antimicrobial resistance. SIGNIFICANCE AND IMPACT OF THE STUDY This study would aid in identifying the commonly circulating ETEC isolates of Kolkata, India, and their prevalent virulence determinants. Knowledge of antibiotic resistance patterns would also help in the appropriate use of antibiotics. Furthermore, the study would aid in identifying the multivalent antigens suitable for region-specific ETEC vaccines with maximum coverage.

Study was done to look for the future neurodevelopmental outcome of the babies with extremely high serum bilirubin level at 1st week of life. Fifty one term and near term babies were enrolled with features of acute bilirubin encephalopathy (ABE), with bilirubin level more than20mg/dl. They were followed up at 3rd and 6th month to observe their neurodevelopment. Neurological outcome was measured with Denver Development Screening Test (DDST-II) and brainstem evoked response audiometry (BERA). The mean peak total serum bilirubin (TSB) was 25.3±2.35(mg/dl). Abnormal developmental was found in 23.5% babies (12 out of 51) and abnormalities were more in the babies whose TSB was beyond 28mg/dl. Abnormal BERA was found among 13.7% babies. TSB value below 25 mg/dl can be considered as safe cut off value for reversibility of bilirubin induced acute brain damage.

The onset of hepatic encephalopathy (HE) heralds a transition to advanced chronic liver disease and is considered a watershed moment in the natural history of cirrhosis. HE is a debilitating neuropsychiatric syndrome, and morbidity and mortality rise steeply following its onset, with less than one-quarter alive after three years. The gut microbiome has prime importance in the pathogenesis of HE with evolution from a healthy gut microbiome to one characterized by reduced bacterial diversity and increased pathogenic resident species. Gut dysbiosis is greater in patients with cirrhosis who develop complications, which correlates with mortality. Manipulation of the gut microbiome is efficacious in the treatment of HE. Here we discuss how the gut microbiome is an important driver of the development and progression of HE. We will discuss how diet, pre- and probiotics, antibiotics, and fecal microbiota transplantation may favorably manipulate the gut microbiome, improving outcomes in patients with cirrhosis.

Globally, enteric fever caused by Salmonella Typhi (S. Typhi, ST) and S. Paratyphi A (SPA) remain one of the major diseases of public health importance. In this study, a total of 457 (380 ST, 77 SPA) blood isolates were collected from three tertiary care hospitals in Kolkata during 2014–18. Additionally, 66 (3.4%) ST and 5 (0.25%) SPA were recovered from blood culture of 1962 patients attending OPD of one pediatric hospital during 2016–18. The study isolates were tested for antimicrobial resistance (AMR) profiles; AMR genes; molecular sub-types by PFGE, MLVA and CRISPR. Among the total 446 ST and 82 SPA isolates, fluoroquinolone (FQ) resistance was very common in both serovars. Ciprofloxacin resistance of 24.9% and 9.8% & ofloxacin resistance of 20.9% and 87.8% were found in ST and SPA respectively. Majority (>70%) of the isolates showed decreased susceptibility to ciprofloxacin (DCS). A single point mutation in gyrA gene (S83F) was responsible for causing DCS in 37.5% (n = 42/112) ST and 63% (n = 46/73) SPA isolates. Multidrug resistance (MDR) was found only in 3.4% ST isolates and encoded the genes blaTEM-1, catA, sul, strA-strB, class 1 integron with dfrA7. All MDR ST (n = 15) possessed non-conjugative non-IncHI1 (180 kb) plasmid except one having conjugative IncHI1 (230 kb) plasmid and one without plasmid. The MDR genes were integrated near chromosomal cyaA gene site in ST with/without the presence of plasmid (nonIncH1). Almost 65.7% resistant ST belonged to H58 haplotype. PFGE showed clonally related isolates with 81% similarity in ST and 87% in SPA. Similarly, CRISPR typing showed less diversity among the isolates. However, the isolates (ST and SPA) were found to be more diverse by MLVA typing (D value 0.987 and 0.938). The study reports decrease in MDR and increase in FQ resistance among typhoidal Salmonella isolates over the years giving interesting information for enteric fever treatment.

ObjectiveThe aims of this study were to describe community antibiotic prescribing patterns in individuals hospitalised with COVID-19, and to determine the association between experiencing diarrhoea, stratified by preadmission exposure to antibiotics, and mortality risk in this cohort.Design/methodsRetrospective study of the index presentations of 1153 adult patients with COVID-19, admitted between 1 March 2020 and 29 June 2020 in a South London NHS Trust. Data on patients’ medical history (presence of diarrhoea, antibiotic use in the previous 14 days, comorbidities); demographics (age, ethnicity, and body mass index); and blood test results were extracted. Time to event modelling was used to determine the risk of mortality for patients with diarrhoea and/or exposure to antibiotics.Results19.2% of the cohort reported diarrhoea on presentation; these patients tended to be younger, and were less likely to have recent exposure to antibiotics (unadjusted OR 0.64, 95% CI 0.42 to 0.97). 19.1% of the cohort had a course of antibiotics in the 2 weeks preceding admission; this was associated with dementia (unadjusted OR 2.92, 95% CI 1.14 to 7.49). After adjusting for confounders, neither diarrhoea nor recent antibiotic exposure was associated with increased mortality risk. However, the absence of diarrhoea in the presence of recent antibiotic exposure was associated with a 30% increased risk of mortality.ConclusionCommunity antibiotic use in patients with COVID-19, prior to hospitalisation, is relatively common, and absence of diarrhoea in antibiotic-exposed patients may be associated with increased risk of mortality. However, it is unclear whether this represents a causal physiological relationship or residual confounding.

Introduction Cerebral palsy (CP) is the most common childhood physical disability, with 80% estimated to be in low-middle-income countries. This study aims to (1) determine the accuracy of General Movements (GMs)/Hammersmith Infant Neurological Examination (HINE) for detecting CP at 18 months corrected age (CA); (2) determine the effectiveness of a community-based parent-delivered early intervention for infants at high risk of CP in West Bengal, India (Learning through Everyday Activities with Parents for infants with CP; LEAP-CP). Methods This study comprises two substudies: (1) a study of the predictive validity of the GMs and HINE for detecting CP; (2) randomised, double-blinded controlled trial of a novel intervention delivered through peer trainers (Community Disability Workers, CDW) compared with health advice (15 fortnightly visits). 142 infants at high risk of CP (‘absent fidgety’ GMs; ‘high risk score’ on HINE) aged 12–40 weeks CA will be recruited to the intervention substudy, with infants randomised based on a computer-generated sequence. Researchers will be masked to group allocation, and caregivers and CDWs naive to intervention status. Visits will include therapeutic modules (goal-directed active motor/cognitive strategies and LEAP-CP games) and parent education. Health advice is based on the Integrated Management of Childhood Illness, WHO. Infants will be evaluated at baseline, post intervention and 18 months CA. The primary hypothesis is that infants receiving LEAP-CP will have greater scaled scores on the Pediatric Evaluation of Disability Inventory—Computer Adaptive Test (mobility domain) at 18 months compared with health advice. Secondary outcomes include infant functional motor, cognitive, visual and communication development; infant growth; maternal mental health. Ethics and dissemination This study is approved through appropriate Australian and Indian ethics committees (see in text) with families providing written informed consent. Findings from this trial will be disseminated through peer-reviewed journal publications and conference presentations. Trial registration number 12616000653460p; Pre-results.

Objectives: Identification of severe acute maternal morbidity (SAMM) has gained importance in recent years in view of falling maternal death rates and thrust on improving quality of maternal health care. Although most of these events occur in developing countries, reporting system for SAMM is poorly developed in these regions. Aim of this study was to determine the incidence and direct causes of postpartum SAMM along with measuring of relevant new indicators on maternal health in an apex institute of India Materials and Methods: Hospital based cross sectional study conducted in India on 109 women with severe post partum complications. Outcome measures were SAMM or death. Results: 99 women had SAMM and there were 10 maternal deaths. Eclampsia was the most common cause of SAMM, but case fatality ratio was higher for PPH. SAMM ratio was 16.22/1000 live births and mortality index was 9.17%. Conclusion: 1 out of every 10 women with SAMM dies in developing countries. Improving facility based care and prompt referral can be a short term measure to quickly reduce the number of maternal deaths. Facility based monitoring and reporting of severe maternal outcome is an important step for scaling up such efforts.

Epidemics of dengue outbreak are frequent in south-east Asian countries. Dengue is a major cause of morbidity and mortality in this region. This prospective observational study was done at Dr BC Roy Memorial for Children during the outbreak in 2005 in Kolkata to know the clinical pattern of dengue cases and to find the possible markers of development of dengue hemorrhagic fever. Two hundred and eighty seropositive cases of dengue were included in the study. Among paediatric population, 5 to 10 years age group was most commonly affected. One-sixth of the cases were from villages indicating the extension of the epidemic in rural areas. Abrupt onset of high fever, non-purulent conjunctival injection, erythematous lips, flushed appearance, myalgia, arthralgia, headache and thrombocytopenia were the predominant features. Rhinitis and pharyngitis were rarely found. Prolonged fever more than 7 days, flushed appearance, pharyngeal congestion, shock evidence, serous effusion, bleeding manifestations, thrombocytopenia, elevated liver enzymes and elevated PCV were associated with development of dengue haemorrhagic fever and dengue shock syndrome.

To identify and analyse the risk factors associated with postpartum haemorrhage (PPH) and assess their impact on the maternal morbidity, a prospective observational study was carried out over a period of one year in a tertiary level referral institute in Kolkata, West Bengal, India. All the cases of PPH were identified and studied. Data analyses were done using Chi-square test. Out of 210 cases of maternal morbidity, 79 (37.6%) were found to have PPH as the causative factor. Uterine atonicity was found to be the main cause leading to 45 cases (56.9%) of PPH. With respect to the mode of delivery severe PPH was found in 34.3% of vaginally and 60% of operatively delivered patients which had statistical significance. More number of severe PPH cases, 17/31 (54.8%), had delivered outside the medical college. Here comes the role of 24-hour quality emergency obstetric care (EMOC), active management of 3rd stage of labour and early referral to the higher centre. The case fatality rate of PPH during the study period was 7.5%. This finding is quite close to the observation made in a North Indian tertiary hospital based study. In order to reduce maternal morbidity and thereby indirectly maternal mortality and to improve the overall maternal health, prevention and control of PPH can play a significant role. An integrated approach at all levels of healthcare delivery system, active management of labour and efficient emergency obstetric care will help in controlling the PPH.

OBJECTIVES. Acute intravascular hemolysis after exchange transfusion with glucose 6-phosphate dehydrogenase–deficient blood has been reported; however, it is not routine to screen donor blood for glucose 6-phosphate dehydrogenase deficiency while performing exchange transfusion. We hypothesized that exchange transfusion with glucose 6-phosphate dehydrogenase–deficient blood would lead to a less-than-expected decrease in total serum bilirubin. The objective of this study was to evaluate the effect of exchange transfusion with glucose 6-phosphate dehydrogenase–deficient blood in neonates with idiopathic hyperbilirubinemia on postexchange total serum bilirubin levels, duration of phototherapy, and need for repeat exchange transfusions. METHODS. All neonates who were undergoing exchange transfusion for idiopathic hyperbilirubinemia were enrolled. A sample of donor blood was collected at the time of exchange transfusion for a glucose 6-phosphate dehydrogenase assay. The standard criteria for starting and stopping phototherapy and exchange transfusion were applied. RESULTS. During the 1-year study period, 21 infants underwent exchange with glucose 6-phosphate dehydrogenase–deficient blood, and 114 neonates with similar baseline characteristics underwent exchange transfusion with glucose 6-phosphate dehydrogenase–normal blood. From 6 to 60 hours after exchange transfusion, there was a significantly lesser drop in total serum bilirubin in the recipients of glucose 6-phosphate dehydrogenase–deficient donor blood compared with recipients of glucose 6-phosphate dehydrogenase–normal blood. The mean duration of phototherapy in the postexchange period and number of infants who underwent repeat exchange transfusions were significantly higher in recipients of glucose 6-phosphate dehydrogenase–deficient donor blood in comparison with control subjects. Concurrently, there was a significantly higher drop in hematocrit and rise in plasma hemoglobin in the glucose 6-phosphate dehydrogenase–deficient donor group. CONCLUSIONS. Exchange transfusion with glucose 6-phosphate dehydrogenase–deficient donor blood leads to a lesser drop in postexchange total serum bilirubin. It prolongs the duration of phototherapy and increases the need for repeat exchange transfusions.

Background Decades after the establishment of clear guidelines for management, mostly due to irrational approach, diarrhea is still a major concern in the developing world, including India. The scenario is even worse in urban slums owing to poor health-seeking and socio-environmental vulnerability. Determining the distribution of rational diarrhea management by practitioners and identification of its important predictors seemed urgent to minimize the potential for antibiotic resistance, diarrhea-related mortality and morbidity in these areas. Methods Between May 2011 and January 2012, 264 consenting, randomly selected qualified and non-qualified practitioners (including pharmacists) were interviewed in the slums of Kolkata, a populous city in eastern India, regarding their characteristics, diarrhea-related knowledge (overall and in six separate domains: signs/symptoms, occurrence/spread, management, prevention/control, cholera and ORS), prescribed antibiotics, intravenous fluid (IVF) and laboratory investigations. Rationality was established based on standard textbooks. Results Among participants, 53.03% had no medical qualifications, 6.06% were attached to Governmental hospitals, 19.32% had best knowledge regarding diarrhea. While treating diarrhea, 7.20%, 17.80% and 20.08% respectively advised antibiotics, IVF and laboratory tests rationally. Logistic regression revealed that qualified and Governmental-sector practitioners managed diarrhea more rationally. Having best diarrhea-related knowledge regarding signs/symptoms (OR=5.49, p value=0.020), occurrence/spread (OR=3.26, p value=0.035) and overall (OR=6.82, p value=0.006) were associated with rational antibiotic prescription. Rational IVF administration was associated with best knowledge regarding diarrheal signs/symptoms (OR=3.00, p value=0.017), occurrence/spread (OR=3.57, p value=0.004), prevention/control (OR=4.89, p value=0.037), ORS (OR=2.55, p value=0.029) and overall (OR=4.57, p value