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Background There is limited data on antibiotic treatment in hospitalized neonates in low- and middle-income countries (LMICs). We aimed to describe patterns of antibiotic use, pathogens, and clinical outcomes, and to develop a severity score predicting mortality in neonatal sepsis to inform future clinical trial design. Methods and findings Hospitalized infants A total of 3,204 infants were enrolled, with median birth weight of 2,500 g (IQR 1,400 to 3,000) and postnatal age of 5 days (IQR 1 to 15). 206 different empiric antibiotic combinations were started in 3,141 infants, which were structured into 5 groups based on the World Health Organization (WHO) AWaRe classification. Approximately 25.9% (n = 814) of infants started WHO first line regimens (Group 1-Access) and 13.8% (n = 432) started WHO second-line cephalosporins (cefotaxime/ceftriaxone) (Group 2-'Low' Watch). The largest group (34.0%, n = 1,068) started a regimen providing partial extended-spectrum beta-lactamase (ESBL)/pseudomonal coverage (piperacillin-tazobactam, ceftazidime, or fluoroquinolone-based) (Group 3-'Medium' Watch), 18.0% (n = 566) started a carbapenem (Group 4-'High' Watch), and 1.8% (n = 57) a Reserve antibiotic (Group 5, largely colistin-based), and 728/2,880 (25.3%) of initial regimens in Groups 1 to 4 were escalated, mainly to carbapenems, usually for clinical deterioration (n = 480; 65.9%). A total of 564/3,195 infants (17.7%) were blood culture pathogen positive, of whom 62.9% (n = 355) had a gram-negative organism, predominantly Klebsiella pneumoniae (n = 132) or Acinetobacter spp. (n = 72). Both were commonly resistant to WHO-recommended regimens and to carbapenems in 43 (32.6%) and 50 (71.4%) of cases, respectively. MRSA accounted for 33 (61.1%) of 54 Staphylococcus aureus isolates. Overall, 350/3,204 infants died (11.3%; 95% CI 10.2% to 12.5%), 17.7% if blood cultures were positive for pathogens (95% CI 14.7% to 21.1%, n = 99/564). A baseline NeoSep Severity Score had a C-index of 0.76 (0.69 to 0.82) in the validation sample, with mortality of 1.6% (3/189; 95% CI: 0.5% to 4.6%), 11.0% (27/245; 7.7% to 15.6%), and 27.3% (12/44; 16.3% to 41.8%) in low (score 0 to 4), medium (5 to 8), and high (9 to 16) risk groups, respectively, with similar performance across subgroups. A related NeoSep Recovery Score had an area under the receiver operating curve for predicting death the next day between 0.8 and 0.9 over the first week. There was significant variation in outcomes between sites and external validation would strengthen score applicability. Conclusion Antibiotic regimens used in neonatal sepsis commonly diverge from WHO guidelines, and trials of novel empiric regimens are urgently needed in the context of increasing antimicrobial resistance (AMR). The baseline NeoSep Severity Score identifies high mortality risk criteria for trial entry, while the NeoSep Recovery Score can help guide decisions on regimen change. NeoOBS data informed the NeoSep1 antibiotic trial (ISRCTN48721236), which aims to identify novel first- and second-line empiric antibiotic regimens for neonatal sepsis. Trial registration ClinicalTrials.gov, (NCT03721302)., Author(s): Neal J. Russell 1,*, Wolfgang Stöhr 2, Nishad Plakkal 3, Aislinn Cook 1, James A. Berkley 4,5,6, Bethou Adhisivam 3, Ramesh Agarwal 7, Nawshad Uddin Ahmed 8, Manica Balasegaram [...]

Objective: To assess clinical characteristics and outcomes of women who underwent concurrent valve replacement with caesarean section for severe rheumatic mitral valve disease with refractory heart failure. Methods: All women admitted to a single centre from 2011 to 2020 with severe rheumatic mitral valve disease, having recurrent episodes of pulmonary edema on optimal medical therapy and contraindication to percutaneous balloon mitral valvotomy, who underwent concurrent valve replacement (for native valve disease) along with caesarean section, were included. Results: Among 1300 pregnancies with rheumatic heart disease, six underwent the concurrent procedure. All had replacement of mitral valve except one who had both aortic and mitral valve replacements, between 33 and 39 weeks of gestation. There were no maternal deaths, and there was one neonatal loss from late-onset sepsis. Conclusion: Pregnant women with severe rheumatic mitral valve disease with refractory heart failure, unsuitable for minimal access interventions, can be considered for a concurrent valve replacement with caesarean section. [ABSTRACT FROM AUTHOR]

Background : The availability of nomograms is crucial for the correct interpretation of pediatric and neonatal echocardiograms. Echocardiographic Z-score applications/websites use Western nomograms as reference, which may not be an appropriate standard for gauging Indian neonates. Currently available Indian pediatric nomograms either have not included neonates or have not been specifically designed for neonates. This gross underrepresentation of neonates renders available nomograms unreliable for use as standards for comparison. Objectives : The objective of this study was to collect normative data for the measurement of various cardiac structures using M-Mode and two-dimensional (2D) echo in healthy Indian neonates and to derive Z-scores for each measured parameter. Methods : Echocardiograms were performed on healthy term neonates (within first 5 days of life). Birth weight and length were recorded, and body surface area was calculated using Haycock's formula. Twenty M-mode and 2D-echo parameters were measured (including left ventricular dimensions, atrioventricular valves, and semilunar valves' annuli sizes, pulmonary artery and branches, aortic root, and arch). Results : We studied 142 neonates (73 males) with a mean age of 1.83 ± 1.12 days and mean birth weight of 2.89 ± 0.39 Kg. Regression equations with linear, logarithmic, exponential and square root models were tested to select the best model of fit for the relationship between birth weight and each echocardiographic parameter. Scatter plots and nomogram charts with Z-scores were prepared for each echocardiographic parameter. Conclusions : Our study provides nomograms with Z-scores for term Indian neonates weighing between 2 kg and 4 kg at birth, within first 5 days of life, for a set of echocardiographic parameters that are frequently used in clinical practice. This nomogram has poor predictability for babies at extremes of birth weight. There is a need for further indigenous studies to include neonates at extremes of weight, both term, and preterm. [ABSTRACT FROM AUTHOR]

Congenital heart defects(CHDs) are an important cause of neonatal mortality and morbidity. With advances in diagnosis and treatment, many defects are now amenable to correction. There is a need for individualized approach to prenatally detected lesions to predict the likely prognosis. Assigning them into risk category helps in prenatal counseling, decision making, referrals and formulation of management plan to improve the outcome. To grade the fetal CHDs according to severity and study its usefulness in decision making. A prospective study at a tertiary care institute between 2016 and 18, including pregnant women with antenatal diagnosis of fetal CHD. Detailed fetal echocardiography was followed by classification of lesions into four risk categories using modified grading system: (A) extremely high risk; (B) high risk (C) moderate risk (D) low risk. Appropriate counseling was provided to facilitate decision making and further management. The grading was reviewed and revised again postpartum/post-mortem for correlation. Of the total 137 cases, almost half (45.53%) were Category B, while Category D, C and A had 24.1%, 20.4% and 10.2% of cases respectively. The mean gestation age at diagnosis was 26.5 weeks. Termination of pregnancy was done in 21 cases, mostly in Category B (71.4%) and of the 116 continued pregnancies, there were 16 intrauterine deaths. Prenatal and postnatal findings were available in 109 cases and kappa analysis for agreement between antenatal and postnatal grading showed good agreement (0.82). Prenatal grading of congenital heart disease is a reliable, structured and simplified tool that can be used for providing counseling and facilitate decision making. [ABSTRACT FROM AUTHOR]

Background: Currently nonselective cyclooxygenase (COX) inhibitors, ibuprofen and indomethacin, are approved drugs for closure of patent ductus arteriosus but have potential toxicities. There are reports of the effectiveness of paracetamol in ductal closure. However, there is paucity of data comparing paracetamol to ibuprofen or indomethacin in relation to the efficacy and safety profile.Methods: This randomized clinical trial was done in our tertiary care neonatal unit from October 2014 to January 2016 after clearance from ethical committee. It was registered with clinical trial registry of India (CTRI/2016/09/007261) and drug controller general of India (CT/Drugs/56/2014). Preterm neonates with clinical suspicion of hemodynamically significant PDA after echo confirmation were included in the study. Randomization was done by stratified randomization through sealed opaque envelopes. A sample size of 150 was estimated with an expected difference in success of closure as 20% between the treatment groups at level of 5% significance and 80% power. The echocardiography was done 24 hours after completion of treatment by a cardiologist blinded to treatment.Results: The baseline parameters were comparable between two groups. One hundred and forty-six babies had hs-PDA, out of which 110 babies were randomized. No significant difference was found between the two groups with respect to PDA closure (RR 0.97, 95%CI 0.78-1.20, p = 1), mortality or cardio-respiratory morbidity. The babies who received ibuprofen had a higher occurrence of acute kidney injury (RR 0.33, 95%CI 0.13-0.85, p = 0.024).Conclusions: Paracetamol is as effective as ibuprofen for PDA closure in preterm neonates. Ibuprofen used for PDA closure in preterms poses an increased risk for acute kidney injury compared to paracetamol. [ABSTRACT FROM AUTHOR]

Byline: Sriram. Krishnamurthy, Parameswaran. Narayanan, Sivaprakasam. Prabha, Nivedita. Mondal, Subramanian. Mahadevan, Niranjan. Biswal, Sadagopan. Srinivasan Background: Although the term acute renal failure was replaced by acute kidney injury (AKI) recently, [...]