Gastric Aspiration Research Articles

Childhood Intra-Thoracic Tuberculosis Clinical Presentation Determines Yield of Laboratory Diagnostic Assays.

Diagnosis of intra-thoracic tuberculosis (ITTB) in children is difficult due to the paucibacillary nature of the disease, the challenge in collecting appropriate specimens, and the low sensitivity of smear microscopy and culture. Culture and Xpert MTB/RIF provide higher diagnostic yield in presumptive TB in adults than in children. Current study was designed to understand poor yield of diagnostic assays in children. Children with presumptive ITTB were subjected to gastric aspirates and induced sputum twice. Samples were tested by Ziehl-Neelsen stain, Xpert MTB/RIF-assay, and MGIT-960 culture. Subjects were grouped as Confirmed, Unconfirmed, and Unlikely TB, and classified as progressive primary disease (PPD, lung parenchymal lesion), and primary pulmonary complex (PPC, hilar lymphadenopathy) on chest X-ray. Of children with culture-positive TB 51/394 (12.9%), culture-negative TB 305 (77.4%), and unlikely TB 38 (9.6%), 9 (2.3%) were smear positive, while 95 (24.1%) were Xpert-MTB/RIF positive. Xpert-MTB/RIF detected 40/51 culture confirmed cases (sensitivity 78.4% and NPV 96.3%). Culture was positive in more children presenting as PPD (p < 0.04). In culture-negative TB group, Xpert positivity was seen in 31% of those with PPD and 11.9% in those with PPC (p < 0.001).Conclusion: Xpert-MTB/RIF improved diagnosis by 2-fold and increased detection of MDR-TB. Both liquid culture and Xpert-MTB/RIF gave higher yield in children with lung parenchymal lesions. Children with hilar lymphadenopathy without active lung parenchymal lesions had poor diagnostic yield even with sensitive nucleic acid amplification tests, due to paucibacillary/localized disease, suggesting possible utility of invasively collected samples in early diagnosis and treatment.

Effectiveness of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis at various stand-alone laboratories in Delhi

BackgroundGlobally, EPTB accounts for 15% of the notified incident TB cases. Laboratory confirmation of EPTB is challenging and majority of the cases remain undetected for a longer time. A major breakthrough in the diagnosis of EPTB was the introduction of nucleic acid amplification tests (NAAT). One such test-the Xpert MTB/RIF assay also known as Cartridge based nucleic acid amplification test (CBNAAT) was endorsed by the Scientific and Technical Advisory Board of the WHO for the diagnosis of Tuberculosis. The present study was conduct to evaluate the outcome of various extrapulmonary samples tested in the year 2019 at different standalone NAAT laboratories in Delhi. Materials and methodsA total of 20,238 samples consisting mainly of Pus (21.77%), Cerebrospinal fluid (CSF) (14.96%), Biopsies (13.87%), Pleural fluid (10.49%), Lymph node aspirations (FNAC aspirates) (6.75%), synovial fluid (0.54%) and gastric aspirates (26.4%) tested at 22 standalone NAAT laboratories were included in this study. ResultsMycobacterium tuberculosis was detected in 3496 samples and resistance to rifampicin was detected in 329 of the samples. The overall yield of all the specimens combined was 17.2%. Highest yield was seen in Lymph nodes aspirates (FNAC) (36.0%), followed by pus (35.4%), tissues (15.7%), synovial fluid (13.5%), Endometrial tissues (10.7%), Pleural fluid (9.5%), Gastric aspirates (9.4%) and CSF (6.5%). The lowest yield was seen in Cavitary fluids (6.2%). ConclusionThe results of this study highlight the usefulness of Xpert MTB/RIF assay in the diagnosis of EPTB. In particular, this assay proved to be of great utility while testing pus samples, tissue samples and lymph node FNACs.

Congenital Tuberculosis in a Neonate Born from a HIV Negative Mother, in a HIV Endemic Country: A Case Report

Introduction Congenital tuberculosis (TB) which is acquired during the intrauterine period or during the normal birth process is rare, with 490 cases reported up to date. Congenital Tuberculosis poses a diagnostic challenge because its clinical presentation and radiographic findings are nonspecific. Case Presentation We present an African neonate born prematurely at gestation age of 32 weeks, weighing 1250 grams at Muhimbili National Hospital. The mother was admitted at the Intensive Care Unit (ICU) before delivery due to empyema thoracis and later on died. She was HIV negative, later on diagnosed with TB and initiated on anti –Tb medications 3 days before her demise which was two weeks post-delivery. The baby who was never breastfed, presented with a history of poor weight gain, persistent fever, cough and difficulty in breathing during the neonatal period. On physical examination she had reduced breath sounds on the right side of the chest and hepatosplenomegaly. Gastric aspirate for Gene Xpert confirmed the presence of Mycobacterium tuberculosis. The patient was initiated on anti –Tb medication and responded well with adequate weight gain and improvement of the clinical symptoms. Conclusion A high index of suspicion is required to diagnose congenital TB, in light of poor response to antibiotics in TB endemic areas, especially when the mother is presenting with respiratory symptoms.

Comparison of effect of Various Combinations of four drugs i.e IV Ondansetron, Ranitidine, Metoclopramide and Omeprazole, to reduce Gastric Fluid Residual Volume and Gastric Acidity in Elective Laparoscopic-Cholecystectomy patients

Background: Inhaling of gastric contents in lower respiratory tract and larynx results in developing of pulmonary aspiration. The acidity of aspirate contents and its volume determines severity of aspiration and is major cause of post-anesthetic mortality. Objective: To compare the effect of four drugs (ranitidine, IV ondansetron, metoclopramide, omeprazole and metoclopramide) in all possible four combinations, to decrease gastric fluid residual volume and gastric acidity in undergoing laparoscopic-cholecystectomy. Design: It was a clinical randomized trial. Study Settings: Trial was conducted at Department of Anesthesiology and ICU, Sheikh Zayed Hospital, Lahore, for a period of 6 months from 01-07-2019 to 31-12-2019. Patients and Methods: A total of 308 patients from both the genders undergoing laparoscopic cholecystectomy were included in this study. Four equal groups were made by random division of patients. Group A: ranitidine &amp; ondansetron, group B: ranitidine &amp; metoclopramide, group C: omeprazole &amp; ondansetron and group D: omeprazole &amp; metoclopramide. Pre-anesthetic medicine was given to all the patients two hours before surgery. For assessing volume of gastric fluid and its pH, an oro-gastric tube was passed. An informed written informed consent was taken from all the patients. Results: Mean age in this study was 36.40±9.15, 33.23±9.13, 36.82±9.37 and 36.57±9.49 years respectively for Group A,B,C and D. Aspirate had mean quantity of 12.56±5.60 ml/kg, 12.65±5.39 ml / kg, 13.68±5.76 ml/kg and 14.34±6.85 ml/kg and he aspirate mean pH was 2.56±0.55, 2.47±0.58, 2.51±0.57 and 2.45±0.58 respectively for group A,B,C and D. Among both the trial groups, this different was insignificant (p-value &gt; 0.05) for both outcomes. Conclusion: All the drug combinations had no significant difference. However, comparatively less pH and volume of gastric fluid was shown by combination of ranitidine plus ondansetron. Therefore, this combination is recommended before general anesthesia for reducing gastric fluid aspirate in patients undergoing surgery. Keywords: Laparoscopic cholecystectomy, Omeprazole, Ranitidine, Metoclopramide, Ondansetron, gastric fluid acidity, pH, gastric fluid volume

Contamination of single fluid-filled intragastric balloons with orogastric fluid is not associated with hyperinflation: an ex-vivo study and systematic review of literature

BackgroundSpontaneous hyperinflation is reported to the Food and Drug Administration as a complication of intragastric balloons. It is postulated that orogastric contamination of the intragastric balloon may cause this phenomenon. We sought to investigate the effects of intentional balloon contamination with gastric contents on intragastric balloon perimeter and contents, whether methylene blue plays a role in preventing spontaneous hyperinflation, and review the available literature on spontaneous hyperinflation.MethodsFour pairs of balloons with different combinations of sterile saline, orogastric contaminants, and methylene blue were incubated in a 37 °C water bath for six months to simulate physiological conditions with serial measurements of balloon perimeter. Our findings were compared against a systematic review across multiple databases to summarize the available literature.ResultsBalloon mean perimeter decreased from 33.5 cm ± 0.53 cm to 28.5 cm ± 0.46 cm (p < 0.0001). No significant differences were seen with the methylene blue group. Only 11 cases were found reported in the literature.ConclusionsDespite contaminating intragastric balloons with gastric aspirates, hyperinflation did not occur, and other factors may be in play to account for this phenomenon, when observed. Rates of hyperinflation remain under-reported in the literature. Further controlled experiments are needed.

Utility of stool CBNAAT in the diagnosis of pediatric pulmonary tuberculosis in India

BackgroundIndia houses 27% of the tuberculosis cases worldwide. Pediatric tuberculosis accounts for 11% cases worldwide. Microbiological confirmation of diagnosis is difficult in children. We aimed to study the proportion of Stool CBNAAT (Cartridge Based Nucleic Acid Amplification Test) and GA CBNAAT positive cases among the presumptive cases of tuberculosis in children and assess diagnostic utility of the Stool CBNAAT in comparison to GA CBNAAT and culture. MethodsOurs was a cross sectional study. 75 children, aged 6 months to 12 years who were presumptive cases of pulmonary tuberculosis and who were unable to expectorate, were enrolled. Gastric aspirate and stool samples were obtained and CBNAAT and culture was done. Results of stool CBNAAT were compared with GA CBNAAT and culture. ResultsOf the 75 children enrolled, 28 were started on antitubercular therapy, 12 of whom were microbiologically confirmed and 16 were started on clinical grounds. Overall, 10 (13.3%) and 11 (14.6%) were positive by Stool CBNAAT and GA CBNAAT respectively. GA CBNAAT and Stool CBNAAT were found to have near perfect agreement (Cohen's kappa 0.834). Stool CBNAAT had sensitivity and specificity of 73% and 97% as compared to culture. ConclusionsStool CBNAAT may be used for bacteriological confirmation of pediatric pulmonary tuberculosis. It was found to have a high degree of concordance with the conventionally used GA CBNAAT. This test would be helpful in endemic countries where there is a dearth of trained staff, especially in the periphery, to obtain gastric aspirate. Discomfort associated with sampling would be avoided.

Effect of prolonged starvation on the body preoperatively and the role of carbohydrate loading

Although recent reports discourage preoperative overnight fasting, many clinicians and surgeons still recommend 6-8 hours of overnight preoperative fasting before conducting elective surgeries. On the other hand, recent guidelines from worldwide multiple anesthesiology societies have suggested that overnight fasting should be approached with flexible durations and proper techniques. Many complications can result from prolonged fasting and preoperative starvation as the duration of fasting usually lasts for more than 12 hours secondary to intraoperative surgical delays. In this literature review, the aim was to discuss the current evidence from studies in the literature about the effect of preoperative starvation and the effect of carbohydrate (CHO) loading on the clinical outcomes of patients. We have noticed that gastric aspiration and respiratory damage can be prevented by preoperative fasting. However, this can lead to the development of other complications such as insulin resistance, a fierce immune response and exaggerated release of acute-phase reactants which might lead to severe organ damage and worsened patient’s prognosis. Accordingly, CHO loading should be carefully approached to properly intervene against these cases to enhance the prognosis of the prospective surgeries and the quality of care for patients.

Maturation of the preterm gastrointestinal tract can be defined by host and microbial markers for digestion and barrier defense

Functionality of the gastrointestinal tract is essential for growth and development of newborns. Preterm infants have an immature gastrointestinal tract, which is a major challenge in neonatal care. This study aims to improve the understanding of gastrointestinal functionality and maturation during the early life of preterm infants by means of gastrointestinal enzyme activity assays and metaproteomics. In this single-center, observational study, preterm infants born between 24 and 33 weeks (n = 40) and term infants born between 37 and 42 weeks (n = 3), who were admitted to Isala (Zwolle, the Netherlands), were studied. Enzyme activity analyses identified active proteases in gastric aspirates of preterm infants. Metaproteomics revealed human milk, digestive and immunological proteins in gastric aspirates of preterm infants and feces of preterm and term infants. The fecal proteome of preterm infants was deprived of gastrointestinal barrier-related proteins during the first six postnatal weeks compared to term infants. In preterm infants, bacterial oxidative stress proteins were increased compared to term infants and higher birth weight correlated to higher relative abundance of bifidobacterial proteins in postnatal week 3 to 6. Our findings indicate that gastrointestinal and beneficial microbial proteins involved in gastrointestinal maturity are associated with gestational and postnatal age.

1179-P: Acute Physiological Effects of Gastric Aspiration for the Treatment of Obesity

AspireAssist® allows aspiration of ~30% of an ingested meal through a percutaneous gastrostomy tube thereby reducing caloric uptake. We evaluated the acute effects of aspiration therapy on postprandial glucose tolerance, responses of gluco-regulatory and appetite-regulating gut hormones, appetite sensations and food intake. Seven AspireAssist®-treated persons without diabetes (median [IQR] age 52 [44;54] years; BMI 35.6 [31.5;40.5] kg/m2) underwent two mixed meal tests on separate days with double-blinded aspiration (aspiration visit) and sham aspiration (sham visit), respectively. Seven age and BMI-matched controls (age 43 [42;54]; BMI 34.1 [31.6;38.7] kg/m2) underwent one meal test (control visit). All mixed meal tests were followed by an ad libitum meal for evaluation of food intake. Compared to sham visits, postprandial glucose tolerance was improved on aspiration visits (median [IQR] baseline-subtracted area under the curve (bsAUC) 170 [88;356] vs. 388 [239;456] mmol/L × min, P = 0.025). Postprandial responses (bsAUCs) of C-peptide, cholecystokinin (CCK) and glucose-dependent insulinotropic polypeptide (GIP) were reduced during aspiration vs. sham visits (113 [28;224] vs. 302 [215;433] nmol/L × min, P = 0.014; 223 [59.4;402] vs. 467 [416;546] pmol/L × min, P = 0.005; and 4,634 [1,488;9,044] vs. 15,382 [9,588;18,850] pmol/L × min, P = 0.025). Glucagon, gastrin, ghrelin and peptide YY, respectively, were similar on aspiration and sham visits. Appetite sensations and ad libitum food intake were similar on aspiration and sham visits. Responses of plasma glucose, gut hormones, appetite sensations and food intake were similar on sham and control visits. In this study, aspiration therapy acutely improved postprandial glucose tolerance without causing a compensatory increase in appetite sensations or food intake at a subsequent ad libitum meal; pointing to acute beneficial metabolic effect of aspiration therapy in addition to the long-term bodyweight-lowering effect of this treatment. Disclosure I. Gether: None. M. M. Jensen: None. T. Jorsal: None. C. Nexøe-larsen: None. L. S. Gasbjerg: Stock/Shareholder; Self; Antag Therapeutics. L. P. S. Naver: None. J. J. Holst: Consultant; Self; Novo Nordisk, Other Relationship; Self; Antag Therapeutics, Bainan Biotech, MSD Corporation, Novo Nordisk, Other Relationship; Spouse/Partner; Antag Therapeutics, Bainan Biotech, Synklino ApS. T. Vilsbøll: Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Mundipharma International, Novo Nordisk, Sanofi, Sun Pharmaceutical Industries Ltd. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S. Funding Augustinus Fonden

Role of C-reactive protein and gastric aspirate polymorphs in early onset neonatal sepsis

Background: Neonatal septicemia is a major cause of morbidity and mortality in the neonates. It presented a diagnostic challenge in the resource poor setting of most of the developing countries of world.Methods: This prospective observational study included all term and preterm babies inborn and outborn referred cases. We included neonates less than 7 days of age with clinical suspicion of sepsis. Significant values for screening tests were taken as total leucocyte count (TLC) of &gt;25,000/&lt;5000, C-reactive protein&gt;0.6 mg/dl and gastric aspirate polymorphs&gt;5 per HPF. Sepsis screen was considered positive for two or more positive tests. Blood culture was used as the gold standard. The statistical analysis was done using SPSS 22.0 version.Results: A total number of 60 subjects were included in the study with 45 (75%) as outborn neonates. Most of them presented with tachypnea followed by difficulty in feeding and lethargy. Significant p values were observed using CRP and gastric aspirate polymorphs as independent sepsis screening markers and when combined together (p&lt;0.001).Conclusions: Sepsis screen in neonates is required for detection of infection as blood culture may be negative and even positive result takes time. CRP showed high sensitivity. Gastric aspirate cytology with its relatively high specificity and negative predictive values serves as a good screening tool to rule out neonates unaffected by sepsis. When all the three parameters were combined together, sensitivity and specificity increased to 100% and 91.67% respectively with p values of 0.001.

Routine prefeed gastric aspiration in preterm infants: a systematic review and meta-analysis.

Despite lack of evidence, the practice of routine prefeed gastric residue aspiration before the next feed is common. Recent studies suggest that this practice might be even harmful. Therefore, we aimed to evaluate the effect of avoiding routine prefeed gastric residue aspiration as compared to routine aspiration, on various clinical outcomes in preterm infants. We searched five different electronic databases (MEDLINE, EMBASE, Web of Science, CINAHL, and Cochrane Library) until March 8, 2021. Only randomized controlled trials comparing the practice of routine prefeed gastric aspiration with no routine aspiration in preterm infants were considered eligible. The random-effects meta-analysis was done using RevMan 5.3 software. Of the 894 unique records identified by our search, we included 6 studies (451 participants) in the review. There was no significant difference in the incidence of necrotizing enterocolitis (RR 0.80; 95% CI 0.31 to 2.08; 421 participants in 5 trials). Avoiding routine prefeed aspiration was associated with achieving full enteral feeds earlier (MD - 3.19 days, 95% CI - 4.22 to - 2.16), shorter duration of hospitalization (MD - 5.32 days; 95% CI - 10.25 to - 0.38), and lower incidence of late-onset sepsis (RR 0.77; 95% CI 0.60 to 0.99). Time to regain birth weight, days of total parenteral nutrition or central venous line usage, culture-positive sepsis, and all-cause mortality did not differ between the two groups.Conclusion: In the absence of other signs of feed intolerance, routine prefeed gastric residue aspiration should be avoided in preterm infants.Prospero registration number: CRD42020197657 What is Known: • Though, routine prefeed aspiration before next feed is a common practice in preterm gavage-fed infants. • Recent study suggests that the omission of routine gastric residual evaluation led to improved weight gain and earlier hospital discharge. What is New: • Low- to moderate-quality evidence suggest that avoiding routine prefeed gastric residue monitoring helps in the reduction of late-onset sepsis, achieving full enteral feeds earlier, and earlier discharge from the hospital. • Abandoning the practice of routine prefeed aspiration in absence of other signs of feed intolerance in preterm low birthweight neonates is safe.

Contribution and Acceptability of Bacteriological Collection Tools in the Diagnosis of Tuberculosis in Children Infected with HIV.

The objective of this study is to evaluate the feasibility and tolerability of new bacteriological samples to diagnose tuberculosis (TB) in HIV-infected children. HIV1-infected children with suspicion of TB in Universitary Hospital Sourô Sanon (Burkina Faso) were included in a prospective cohort study. Children underwent three gastric aspirates (GA) if aged <4 years; two GA, one string test (ST) if aged 4-9 years and three sputum, one ST if aged 10-13 years. All children underwent one nasopharyngeal aspirate (NPA) and one stool sample. To assess feasibility and tolerability of procedures, adverse events were identified and pain was rated on different scales. Samples were tested by microscopy, culture, GeneXpert® (Xpert®). Sixty-three patients were included. Mean age was 8.92 years, 52.38% were females. Ninety-five GA, 67 sputum, 62 NPA, 60 stool and 55 ST had been performed. During sampling, the main adverse events were cough at 68/95 GA and 48/62 NPA; sneeze at 50/95 GA and 38/62 NPA and vomiting at 4/55 ST. On the behavioral scale, the average pain score during collection was 6.38/10 for GA; 7.70/10 for NPA and 1.03/10 for ST. Of the 31 cases of TB, bacteriological confirmation was made in 12 patients. ST, stool is well-tolerated alternatives specimens for diagnosing TB in children. NPA has a poor feasibility and tolerability in children.

Ultrasound Assessment of Gastric Emptying in Premature Infants Treated With Non-Invasive Ventilatory Support.

Nasal continuous positive airway pressure (CPAP) introduces positive pressure of air into both the trachea and stomach, which may affect gastric emptying. The rate of gastric emptying can be estimated by ultrasound (US) in neonates by two validated techniques: "antral cross-sectional area" (ACSA, two-dimensional estimate of the surface area at the gastric antrum), and "spheroid gastric volume" (spheroid, three-dimensional estimate of the stomach volume). To compare gastric emptying rates in neonates on machine-derived nasal CPAP (MD-nCPAP, Avea and RAM cannula) with those on bubble CPAP (bCPAP, Fisher Paykel and Babi.Plus nasal prongs). Ultrasound measurements of the amount of the milk in the stomach were performed before feeding and at 1, 2, and 3 hours after the start of feeding, using both the ACSA and spheroid methods. Rates of gastric emptying were calculated during the "early" (1-2 hours) and "late" (2-3 hours) phases after feeding. We recruited 32 infants (25-34 weeks gestational age, full enteral tube feedings, on nasal CPAP). Seventeen infants were treated with MD-nCPAP (median birth weight 1015 g [interquartile range (IQR): 870-1300], gestational age 28 weeks [IQR: 27-29], postnatal age 20 days [IQR: 14-28]), whereas 15 infants were treated with bCPAP (median birth weight 960 g [IQR: 855-1070], gestational age 27 weeks [IQR: 26-28], postnatal age 17 days [IQR: 15-25]). Gastric emptying rates (% emptied/min) were significantly faster in the "early" compared to the "late" phase for all infants. There were no significant differences in the rates of gastric emptying (either "early" or "late") or volumes of gastric residuals between infants receiving MD-nCPAP or bCPAP, measured by either method. Although no feeding intolerance was seen in either group, the volumes of residual gastric contents measured by both methods were higher than the volumes traditionally considered abnormal when obtained by gastric tube aspiration. Gastric emptying is faster during the "early" compared to the "late" phase. Gastric emptying rates are not different in infants receiving MD-nCPAP versus bCPAP. The presence of large residual gastric contents in infants who are tolerating feedings challenges the value of traditional gastric aspiration for the assessment of feeding tolerance in infants.

General anesthesia for emergency cesarean delivery: simulation-based evaluation of residents

IntroductionDecreased rates of General Anesthesia (GA) for Cesarean Section (C-section) create a learning problem for anesthesia trainees. In this context, training the management of GA for C-section using simulation techniques allows a safe environment for exposure, learning, performance improvement, and capability retention. ObjectiveAnalyze anesthesia residents’ performance regarding a simulated clinical case of GA for emergency C-section and identify specific deficits in skill acquisition. MethodsBetween 2015 and 2018, we evaluated the performance of 25 anesthesiology residents challenged by a simulated clinical case of GA for emergency C-section after the conclusion of the obstetric anesthesia rotation. Each resident performed the clinical case once followed by the assessment of their performance. Final scores were given according to the completion rate of 14-tasks, going from 0% to 100%. Two study groups were considered according to residency year for subsequent comparison of results (Group 1, second and third residency years and Group 2, fourth and fifth residency years). Results and discussionMean score was 64.29% ± 13.62. Comparatively, Group 1 obtained a higher score than Group 2 (70.63% ± 14.02 vs. 60.27% ± 11.94), although with no statistically significant difference (p = 0.063). The tasks most frequently accomplished were opioid administration (100%), rapid sequence technique (100%), pre-oxygenation (92%), gastric content aspiration prophylaxis (84%), and previous clinical history (84%). Conversely, the tasks less frequently accomplished were confirming presence of pediatrician (64%), oxytocin administration (56%), PONV prophylaxis (56%), and preoperative airway assessment (48%). ConclusionThe performance of the residents observed in this study was comparable to results previously published. The final score did not depend on the residency year.

Gluten Degradation, Pharmacokinetics, Safety, and Tolerability of TAK-062, an Engineered Enzyme to Treat Celiac Disease

Celiac disease (CeD) is an immune-mediated disorder triggered by the ingestion of gluten. Despite adhering to a gluten-free diet (the only management option available to patients with CeD), many patients continue to experience symptoms and intestinal injury. Degradation of immunogenic fractions of gluten peptides in the stomach has been proposed as an approach to reduce toxicity of ingested gluten; however, no enzymes evaluated to date have demonstrated sufficient gluten degradation in complex meals. TAK-062 is a novel, computationally designed endopeptidase under development for the treatment of patients with CeD. Pharmacokinetics, safety, and tolerability of TAK-062 100-900 mg were evaluated in a phase I dose escalation study in healthy participants and patients with CeD. Gluten degradation by TAK-062 was evaluated under simulated gastric conditions invitro and in healthy participants in the phase I study, with and without pretreatment with a proton pump inhibitor. Residual gluten (collected through gastric aspiration in the phase I study) was quantified using R5 and G12 monoclonal antibody enzyme-linked immunosorbent assays. Invitro, TAK-062 degraded more than 99% of gluten (3 g and 9 g) within 10 minutes. In the phase I study, administration of TAK-062 was well tolerated and resulted in a median gluten degradation ranging from 97% to more than 99% in complex meals containing 1-6 g gluten at 20-65 minutes postdose. TAK-062 is well tolerated and rapidly and effectively degrades large amounts of gluten, supporting the development of this novel enzyme as an oral therapeutic for patients with CeD. (ClinicalTrials.gov: NCT03701555, https://clinicaltrials.gov/ct2/show/NCT03701555.).

A STUDY ON COMPARISON BETWEEN INTERMITTENT AND DAILY THERAPY FOR TREATING PULMONARY TUBERCULOSIS IN CHILDREN WITH SPECIAL REFERENCE TO EFFICACY AND OUTCOME.

This randomized controlled trial and prospective study “Comparison between intermittent &amp; daily therapy for treating pulmonary tuberculosis in children with special reference to efficacy &amp; outcome“ was conducted in S.C.B. Medical College and Hospital &amp; S.V.P. P.G.I.P., Cuttack under the supervision of R.N.T.C.P. Centre of S.C.B. Medical college, Cuttack. All the suspected cases, after screening, were diagnosed to have Pulmonary Tuberculosis according to WHO recommendation and then divided into two groups randomly comprising of 45 each.One group was given Daily regimen and other group Intermittent regimen therapy.Among the Daily Treatment group,majority of cases (2761.4%) became symptom free by 1 month,whereas,9 (20.5%) and 8 (17.7%) children took 15 days and 2 months respectively to be free from the symptoms.Among the Intermittent Treatment group, majority of cases (2555.5%) became symptom free by 1 month, whereas, 7 (15.5%) and 8 (17.7%) children took 15 days and 2 months respectively. Majority cases had weight gain ranging from 2-4 kg. Complete radiological improvement was remarkable in daily treatment group. Gastric aspirate &amp; sputum conversion. at 2 month is 100% for both daily as well as intermittent regimen. At 6 months after the completion of therapy, there was not a single case of relapse in both groups. Majority (4497.7%/4088.8 %) got cured. From the present study we can conclude that daily anti-tubercular therapy is better in terms of symptomatic relief as well as radiological changes at 6 months, than that of intermittent therapy in the treatment of childhood pulmonary tuberculosis.

Poor adherence to TB diagnosis guidelines among under-five children with severe acute malnutrition in central India: A missed window of opportunity?

In India, under-five children with Severe Acute Malnutrition (SAM) are referred to Nutritional Rehabilitation Centers (NRCs). NRCs screen the causes of SAM including tuberculosis (TB). The national TB programme recommends upfront testing with a rapid molecular test if TB is suspected in children. We estimated the yield of and adherence to the TB diagnostic guidelines (clinical assessment and assessment for microbiological confirmation) among under-five children with SAM admitted at NRCs (six in district Sagar and four in district Sheopur) of Madhya Pradesh, India in 2017. We also explored the challenges in screening from the health care providers' perspective. It was an explanatory mixed method study. The NRC records were reviewed This was followed by three key informant interviews and three focus group discussions among staff of NRC and TB programme. Manual descriptive thematic analysis was performed. Of 3230, a total of 2665(83%) children underwent Mantoux test, 2438(75%) underwent physical examination, 2277(70%) were asked about the symptoms suggestive of TB, 1220(38%) underwent chest radiograph and 485(15%) were asked for recent contact with TB. A total of 547(17%) underwent assessment for microbiological confirmation. Of 547, a total of 229 gastric aspirate specimens underwent rapid molecular test (24% positive) and 318 underwent sputum microscopy (44% positive). A total of 223 were diagnosed as TB (195 microbiologically and 28 clinically confirmed) and 209 were initiated on anti-TB treatment. The treatment outcome was favourable (cure or treatment completed) for 70(31%) and not recorded for 121(54%). The main perceived challenges in screening for TB were poor team skills, lack of diagnostic facilities and poor understanding of the guidelines due to inadequate training. Though NRCs provided a unique window of opportunity for the screening and management of TB among under-five children with SAM, the utilization of this opportunity remained suboptimal.

Early versus late tube feeding initiation after PEG tube placement: Does time to feeding matter?

Variation exists in the timing of tube feed initiation after percutaneous endoscopic gastrostomy (PEG) tube placement. The aim of our study was to review outcomes of early tube feed (ETF) versus late tube feed (LTF) initiation after PEG tube placement. We performed a retrospective review of all trauma patients who underwent PEG tube placement from 1/2014 to 12/2018. ETF was defined as initiation<24h and LTF>24h after placement. The primary outcome measure was feeding intolerance and secondary outcomes included post-operative complications. All statistical analyses were performed using standard statistical methods (e.g. Pearson's Chi-squared, Fisher's exact and Mann Whitney-U tests). There were 295 patients (164 ETF and 131 LTF) that received a PEG tube at our level 1 trauma center. There was no difference with feeding intolerance at 12h (5% vs. 4%; p=0.88), 24h (1% vs. 2%; p=1.00), and 48h (4% vs. 4%; p=1.00). There was no difference when comparing intolerance symptoms such as nausea and vomiting (1% vs. 2%; p=0.79), abdominal tenderness (2% vs. 3%; p=0.76), high gastric residuals (2% vs. 2%; p=1.00) and aspiration (0% vs. 2%; p=0.39). There was no difference when comparing post-operative complications (4% vs. 8%; p=0.21). Early tube feeding after PEG placement is safe and equivalent to late tube feeding in the adult trauma population. Future prospective studies are warranted to establish the optimal timing for initiation of tube feeds after PEG tube placement.

A cross sectional study of in-hospital cases of Pediatric Tuberculosis detected by CBNAAT at a tertiary care teaching hospital of Central India.

Background: Childhood tuberculosis is difficult in the identification of the organism due to impropersampling as well as low sensitivity of the smear. Newer diagnostic methods like Cartridge basednucleic acid amplification tests (CBNAAT) can rapidly identify Mycobacterium tuberculosis withimproved sensitivity over the smear testing. Material &amp; Method:This observational record basedcross-sectional study was undertaken to identify the epidemiology of tubercular infection in childrendiagnosed with CBNAAT. The study was carried out by analyzing the data of children from six monthsto 18 years who were diagnosed with Tuberculosis and treated with anti-tuberculosis therapy (ATT)from April 2018 to March 2020. Results: Data of a total of 166 patients was analyzed. 42% ofoverall collected samples were reactive to CBNAAT testing for tuberculosis. 40 gastric aspiratesamples were collected and only four (10%) turned reactive for tuberculosis by CBNAAT. None of thepediatric samples was positive for MDR TB. 66% of children completed treatment and 33% weredeclared cured. Conclusion: 42% positivity after CBNAAT testing for tuberculosis infection incollected samples of sputum and gastric aspirate where only 10% yield in GA samples.

Sensitive and Feasible Specimen Collection and Testing Strategies for Diagnosing Tuberculosis in Young Children

Criterion-standard specimens for tuberculosis diagnosis in young children, gastric aspirate (GA) and induced sputum, are invasive and rarely collected in resource-limited settings. A far less invasive approach to tuberculosis diagnostic testing in children younger than 5 years as sensitive as current reference standards is important to identify. To characterize the sensitivity of preferably minimally invasive specimen and assay combinations relative to maximum observed yield from all specimens and assays combined. In this prospective cross-sectional diagnostic study, the reference standard was a panel of up to 2 samples of each of 6 specimen types tested for Mycobacterium tuberculosis complex by Xpert MTB/RIF assay and mycobacteria growth indicator tube culture. Multiple different combinations of specimens and tests were evaluated as index tests. A consecutive series of children was recruited from inpatient and outpatient settings in Kisumu County, Kenya, between October 2013 and August 2015. Participants were children younger than 5 years who had symptoms of tuberculosis (unexplained cough, fever, malnutrition) and parenchymal abnormality on chest radiography or who had cervical lymphadenopathy. Children with 1 or more evaluable specimen for 4 or more primary study specimen types were included in the analysis. Data were analyzed from February 2015 to October 2020. Cumulative and incremental diagnostic yield of combinations of specimen types and tests relative to the maximum observed yield. Of the 300 enrolled children, the median (interquartile range) age was 2.0 (1.0-3.6) years, and 151 (50.3%) were female. A total of 294 met criteria for analysis. Of 31 participants with confirmed tuberculosis (maximum observed yield), 24 (sensitivity, 77%; interdecile range, 68%-87%) had positive results on up to 2 GA samples and 20 (sensitivity, 64%; interdecile range, 53%-76%) had positive test results on up to 2 induced sputum samples. The yields of 2 nasopharyngeal aspirate (NPA) samples (23 of 31 [sensitivity, 74%; interdecile range, 64%-84%]), of 1 NPA sample and 1 stool sample (22 of 31 [sensitivity, 71%; interdecile range, 60%-81%]), or of 1 NPA sample and 1 urine sample (21.5 of 31 [sensitivity, 69%; interdecile range, 58%-80%]) were similar to reference-standard specimens. Combining up to 2 each of GA and NPA samples had an average yield of 90% (28 of 31). NPA, in duplicate or in combination with stool or urine specimens, was readily obtainable and had diagnostic yield comparable with reference-standard specimens. This combination could improve tuberculosis diagnosis among children in resource-limited settings. Combining GA and NPA had greater yield than that of the current reference standards and may be useful in certain clinical and research settings.