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Background: Short-term peripheral venous catheters-related bloodstream infections (PVCR-BSIs) rates have not been systematically studied in developing countries, and data on their incidence by number of device-days are not available., Methods: Prospective, surveillance study on PVCR-BSI conducted from September 1, 2013 to May 31, 2019 in 204 intensive care units (ICUs), members of the International Nosocomial Infection Control Consortium (INICC), from 57 hospitals in 19 cities of India. We applied US INICC definition criteria and reported methods using the INICC Surveillance Online System., Results: We followed 7,513 ICU patients for 296,893 bed-days and 295,795 short term peripheral venous catheter (PVC)-days. We identified 863 PVCR-BSIs, amounting to a rate of 2.91/1,000 PVC-days. Mortality in patients with PVC but without PVCR-BSI was 4.14%, and 11.59% in patients with PVCR-BSI. The length of stay in patients with PVC but without PVCR-BSI was 4.13 days, and 5.9 days in patients with PVCR-BSI. The micro-organism profile showed 68% of gram negative bacteria: Escherichia coli (23%), Klebsiella spp (15%), Pseudomonas aeruginosa (5%), and others. The predominant gram-positive bacteria were Staphylococcus aureus (10%)., Conclusions: PVCR-BSI rates found in our ICUs were much higher than rates published from industrialized countries. Infection prevention programs must be implemented to reduce the incidence of PVCR-BSIs., (Copyright © 2020 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the effect of fluconazole prophylaxis on invasive fungal infection (IFI) in very low birth weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU)., Methods: VLBW infants receiving antibiotics for more than 3 days were randomized to receive either fluconazole (6 mg/kg) or placebo, every other day for 7 days followed by everyday till day 28 or discharge whichever was earlier. The primary outcome was IFI, and secondary outcome was fungal attributable mortality and all-cause mortality., Results: The incidence of IFI was significantly lower (21%) in the fluconazole group compared to the control group (43.2%, 95%CI 0.09-0.37, p < 0.05). The ARR (absolute risk reduction) was 22.2% and the NNT (number needed to treat) was 5. Fungal attributable mortality was also lower in the fluconazole group (2.6% versus 18.9%, 95%CI 0.003-0.52, p < 0.05)., Conclusion: In VLBW neonates on the NICU, use of fluconazole prophylaxis decreases IFI and fungal attributable mortality.

Background of the Study: Preterm infants are managed with antibiotics for sepsis, including suspected or probable sepsis. This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome, which lacks biodiversity and increases the risk for late-onset sepsis (LOS). Probiotics have been proven to reduce the risk for necrotizing enterocolitis, but evidence for prevention of LOS is inconclusive. Probiotic effect depends also on the strain used, dose and indication for use. This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS., Objectives: To study B.clausii given prophylactically to preterm neonates for prevention of LOS., Design: Double-blinded, placebo-controlled, randomized trial., Settings: Tertiary care neonatal unit in India., Participants: Consecutive preterm neonates <34 weeks, admitted from 1 March 2012 to 28 February 2014 were stratified as extreme preterm and very preterm., Intervention: Randomized to receive either probiotic or placebo for 6 weeks, discharge from hospital, death or occurrence of sepsis, whichever was earlier., Primary Outcome: Incidence of definite and probable LOS in probiotic group compared with placebo., Results: Of 326 eligible preterm infants, 244 were enrolled and 82 were excluded. Of these, 120 were stratified as extreme preterm and randomized to receive placebo (n = 59) and probiotic (n = 61). Of 124 babies stratified as very preterm, an equal number was randomized to receive placebo (n = 62) and probiotic (n = 62). There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [29% vs. 23%; relative risk (RR) 1.27; 95% confidence interval (CI) 0.88-1.66; p = 0.36] and the very preterm group (13% vs. 10%; RR 1.33; 95% CI 0.96-1.70; p = 0.32). Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm (RR 0.82; 95% CI 0.74-0.88) and the very preterm (RR 0.67; 95% 0.32-0.77)., Conclusions: Prophylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo., (© The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objectives: To evaluate the efficacy of bovine lactoferrin (BLF) in preventing first episode of late-onset sepsis (LOS) in low birth weight (LBW) neonates., Methods: In this study conducted from May 2012 to July 2013 in the neonatal intensive care unit (NICU) of a tertiary care hospital, inborn asymptomatic neonates, <2000 g, admitted to NICU in first 12 h of birth with no maternal risk factors for sepsis were randomized to receive BLF or placebo from 1st to 28th day of life. The incidence of culture-proven sepsis and sepsis-attributable mortality after 72 h of life was recorded. Increasing doses of BLF were used with higher birth weights., Results: Incidence of first episode of culture-proven LOS was significantly lower in the BLF group vs. placebo [2/63 (3.2%) vs. 9/67(13.4%); risk ratio, 0.211; 95% CI, 0.044-1.019; p = 0.036]. Statistically significant reduction in the sepsis-attributable mortality was also seen after use of prophylactic BLF [0/63 (0%) vs. 5/67 (7.5%); p = 0.027]., Conclusion: BLF supplementation in LBW neonates reduced the incidence of first episode of LOS., (© The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: To study whether disposable diapers decrease the incidence of neonatal infections compared with cloth diapers in a level II neonatal intensive care unit (NICU)., Method and Material: All neonates admitted to the NICU and having duration of stay >48 h were enrolled. Those babies with signs and symptoms of infection were screened with septic screen and/or blood culture., Results: The primary outcome of the study was incidence of probable sepsis. Of 253 babies enrolled in the study period, probable sepsis was present in 101 (39.9%) infants in the total study group and was higher in cloth diaper group as compared with disposable diaper group (p = 0.01). For an average NICU stay of 6 days, cloth diapers would cost Rs. 241 vs. Rs. 162 for disposable diaper for any infant., Conclusion: Usage of disposable diapers decrease the incidence of probable sepsis in babies admitted to NICU. It is also cost effective to use disposable diapers in the NICU., (© The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objectives: To assess the effect of the probiotic VSL#3 in prevention of neonatal sepsis in low birthweight (LBW) infants., Design: Randomised, double-blind, placebo-controlled trial., Setting: Community setting in rural India., Participants: LBW infants aged 3-7 days., Interventions: Infants were randomised to receive probiotic (VSL#3, 10 billion colony-forming units (cfu)) or placebo for 30 days, and were followed up for 2 months., Main Outcome Measure: Possible serious bacterial infection (PSBI) as per the Integrated Management of Neonatal Childhood Illnesses algorithm, as diagnosed by fieldworkers/physicians., Results: 668 infants were randomised to VSL#3 and 672 to placebo. By intention-to-treat analysis, the risk of PSBI among infants in the overall population of LBW infants was not statistically significant (RR 0.79 (95% CI 0.56 to 1.03)). Probiotics reduced median days of hospitalisation (6 days vs 3 days in probiotics) (p=0.018) but not the risk of hospitalisation (RR 0.66 (95% CI 0.42 to 1.04). The onset of PSBI in 10% of infants occurred on the 40th day in the probiotics arm versus the 25th day in the control arm (p=0.063)., Conclusions: Daily supplementation of LBW infants with probiotics VSL#3 (10 billion cfu) for 30 days led to a non-significant 21% reduction in risk of neonatal sepsis. A larger study with sufficient power and a more specific primary end point is warranted to confirm the preventive effect of VSL#3 on neonatal sepsis in LBW infants., Trial Registration Number: The study is registered at the Clinical Trial Registry of India (CTRI/2008/091/000049)., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Aim: To compare topical application of chlorhexidine for umbilical cord care with conventional dry care for prevention of neonatal sepsis in neonatal intensive care unit (NICU)., Methods: The study was conducted in the NICU of a teaching hospital in north India between 2010 and 2011. Newborns (≥ 32 weeks of gestation and weighing ≥ 1500 g) were randomized into chlorhexidine application and dry care groups. Data regarding time of cord separation, umbilical sepsis and neonatal sepsis were recorded., Results: One hundred forty (dry care group 70, chlorhexidine group 70) were enrolled and finally analysed. A significant difference was observed among groups in terms of time to cord separation and incidence of blood culture-proven sepsis though there was no statistical difference noted among the groups with regards to umbilical infection, probable sepsis and meningitis., Conclusion: Use of chlorhexidine for umbilical cord care prevents sepsis in the NICU.

Background: About a million newborns die each year in India, accounting for about a fourth of total global neonatal deaths. Infections are among the leading causes of neonatal mortality. Care practices immediately following delivery contribute to newborns' risk of infection and mortality., Objectives: This study examined the association between clean cord care practices and neonatal mortality in rural Uttar Pradesh, India., Methods: The study used data from a household survey conducted to evaluate a community-based intervention program in two districts of Uttar Pradesh, India. Analysis included data from 5741 singleton live births delivered at home during 2005. The association between clean cord care (clean instrument used to cut cord, clean thread used to tie cord and antiseptics or nothing applied to the cord) and neonatal mortality was estimated using multivariate logistic regression models., Results: Thirty per cent of the study mothers practiced clean cord care. Neonatal mortality rate was significantly lower among newborns exposed to clean cord care (36.5/1000 live births, 95% CI 28.0 to 46.8) than those who did not practice (53.0/1000 live births, 95% CI 46.1 to 60.6). Clean cord care was associated with 37% lower neonatal mortality (OR=0.63; 95% CI 0.46 to 0.87) after adjusting for mother's age, education, caste/tribe, religion, household wealth, newborn thermal care practice and care-seeking during the first week after birth and study arms., Conclusions: Promoting clean cord care practice among neonates in community-based maternal and newborn care programs has the potential to improve neonatal survival in rural India and similar other settings.

Background: Sepsis accounts for up to 15% of an estimated 3.3 million annual neonatal deaths globally. We used data collected from the control arms of three previously conducted cluster-randomised controlled trials in rural Bangladesh, India, and Nepal to examine the association between clean delivery kit use or clean delivery practices and neonatal mortality among home births., Methods and Findings: Hierarchical, logistic regression models were used to explore the association between neonatal mortality and clean delivery kit use or clean delivery practices in 19,754 home births, controlling for confounders common to all study sites. We tested the association between kit use and neonatal mortality using a pooled dataset from all three sites and separately for each site. We then examined the association between individual clean delivery practices addressed in the contents of the kit (boiled blade and thread, plastic sheet, gloves, hand washing, and appropriate cord care) and neonatal mortality. Finally, we examined the combined association between mortality and four specific clean delivery practices (boiled blade and thread, hand washing, and plastic sheet). Using the pooled dataset, we found that kit use was associated with a relative reduction in neonatal mortality (adjusted odds ratio 0.52, 95% CI 0.39-0.68). While use of a clean delivery kit was not always accompanied by clean delivery practices, using a plastic sheet during delivery, a boiled blade to cut the cord, a boiled thread to tie the cord, and antiseptic to clean the umbilicus were each significantly associated with relative reductions in mortality, independently of kit use. Each additional clean delivery practice used was associated with a 16% relative reduction in neonatal mortality (odds ratio 0.84, 95% CI 0.77-0.92)., Conclusions: The appropriate use of a clean delivery kit or clean delivery practices is associated with relative reductions in neonatal mortality among home births in underserved, rural populations.

Objective: To determine the independent risk factors for early onset neonatal sepsis (EONS) in a setting where the policy is to use intrapartum antibiotic prophylaxis (IAP) for known risk factors., Design: Prospective cohort study., Setting: Level III neonatal unit in a developing country., Patients: Consecutive mother-infant dyads (gestation < or =34 weeks) with no major neonatal malformations., Interventions: Thirteen putative maternal and neonatal risk factors and use of IAP were assessed. Neonates were followed until 72 h of life for signs of EONS. Blood cultures were drawn on clinical suspicion of EONS and/or prior to starting prophylactic antibiotics for high risk asymptomatic neonates., Main Outcome: Culture-proven EONS (onset at <72 h)., Results: 601 mother-infant dyads were enrolled (mean (SD) gestation=31.8 (2) weeks; mean (SD) birth weight 1559.4 (452) g). The best fitted multivariable logistic regression model had six independent risk factors (adjusted OR (95% CI)): vaginal examinations > or =3 (9.5 (3 to 31)), clinical chorioamnionitis (8.8 (2 to 43)), birth weight <1500 g (2.8 (2 to 5)), male sex (2.7 (2 to 5)), gestation <30 weeks (2 (1 to 4)) and no IAP (2 (1.04 to 4)). Regression coefficients were converted into scores of 6, 6, 3, 3, 2 and 2, respectively. Internal prediction accuracy was 86.5% and c statistic was 0.75 (95% CI 0.70 to 0.81, p<0.001)., Conclusions: Vaginal examinations > or =3, clinical chorioamnionitis, birth weight <1500 g, male sex, gestation <30 weeks and no intrapartum antibiotics were independent risk factors for EONS among preterm infants of < or =34 weeks' gestation.

Background: Invasive pneumococcal disease (IPD) is vaccine-preventable but few data on the incidence of PD exist for Indian children., Aims: To assess the feasibility of implementing prospective, population-based surveillance for PD among children less than five years of age. Settings and Design :Hospitals and health agencies, Bangalore, India. Retrospective review and analysis of hospitalization records as well as public health and demographic data., Material and Methods: Records for 2006 hospitalizations for pneumococcal disease-associated syndromes (meningitis, pneumonia and sepsis) were identified at three pediatric referral hospitals (Indira Gandhi Institute of Child Health, Kempegowda Institute of Child Health and Vani Vilas Hospital) in Bangalore using International Classification of Diseases, 9th revision codes. Hospital microbiology laboratory records were assessed to ensure capacity for identifying S. pneumoniae. Population data were identified from national census and polio surveillance data., Results: The Bangalore city southern zone includes 33 wards occupying 51 Km 2 with 150,945 children between 0-5 years of age served by three referral pediatric hospitals. From January--December 2006, records of these three hospitals showed 2,219 hospitalizations of children less than five years of age (967 pneumonia, 768 sepsis, and 484 meningitis) with PD-associated diagnoses (southern zone area incidence: 0.15/100,000 PD-associated hospitalizations, less than five years of age). There were 178 deaths in children less than five years of age, of which 87 were attributable to sepsis, 56 to pneumonia and 35 to meningitis., Conclusion: Our analysis suggests that the PD-associated disease burden in Bangalore is high and local institutions have capacity for population-based surveillance. In a prospective study, systematic attention to potential barriers in identifying children with pneumococcal infections will improve estimation of IPD incidence in India.

Infections are the single largest cause of neonatal deaths globally. According to National Neonatal Perinatal Database (2002-03), the incidence of neonatal sepsis in India was 30 per 1000 live-births; klebsiella pneumoniae and staphylococcus aureus were the two most common organisms isolated. Based on the onset, neonatal sepsis is classified into two major categories: early onset sepsis, which usually presents with respiratory distress and pneumonia within 72 hours of age and late onset sepsis, that usually presents with septicemia and pneumonia after 72 hours of age. Clinical features of sepsis are non-specific in neonates and a high index of suspicion is required for the timely diagnosis of sepsis. Although blood culture is the gold standard for the diagnosis of sepsis, culture reports would be available only after 48-72 hours. A practical septic screen for the diagnosis of sepsis has been described and some suggestions for antibiotic use have been included in the protocol.

Objective: Observations on a cohort of neonates in the preintervention year of the field trial of home-based neonatal care (HBNC) in rural Gadchiroli, India, showed that preterm birth and low birth weight (LBW), <2500 g, constituted the most important risk factors. Owing to a limited access to hospital care, most neonates were managed at home in the subsequent intervention years. The objective of this paper is to evaluate the feasibility and effectiveness of managing LBW and preterm neonates in home setting., Design: We retrospectively analyzed data from the intervention arm (39 villages) in the HBNC trial. Feasibility was assessed by coverage and by quality (19 indicators) of care. Effectiveness was evaluated by change in case fatality (CF) and in the incidence of comorbidities in LBW or preterm neonates by comparing the preintervention year (1995 to 1996) with the intervention years (1996 to 2003)., Results: During 1996 to 2003, total 5919 live births occurred in the intervention villages, out of whom 5510 (93%) received HBNC. These included 2015 LBW neonates and 533 preterm neonates, out of whom 97% received only home-based care. The coverage and quality of interventions assessed on 19 indicators was 80.5%. The CF in LBW neonates declined by 58% (from 11.3 to 4.7%, p<0.001), and in preterm neonates, by 69.5% (from 33.3 to 10.2%, p<0.0001). Incidence of the major comorbidities, viz., sepsis, asphyxia, hypothermia and feeding problems, declined significantly. Preterm-LBW neonates without sepsis (270) received only supportive care -- CF in them decreased from 28.2 to 11.5% (p<0.01), and those with sepsis (53) received supportive care and antibiotics -- CF in them decreased from 61 to 13.2% (p<0.005). Supportive care contributed 75% and treatment with antibiotics 25% in the total averted deaths in preterm-LBW neonates. The intrauterine growth restriction (IUGR)-LBW neonates without sepsis (1409) received only supportive care -- the CF was unchanged, and 181 with sepsis received supportive care and antibiotics -- the CF decreased from 18.4 to 8.8% (p<0.05). Treatment with antibiotics explained entire reduction in mortality in IUGR neonates. In total, 55 deaths in LBW neonates were averted by supportive care and 35 by the treatment with antibiotics., Conclusions: Home-based management of LBW and the preterm neonates is feasible and effective. It remarkably improved survival by preventing comorbidities, by supportive care, and by treating infections.

A prospective study was carried out in a burn unit of a tertiary care referral centre in North India. Patients with 20-70% TBSAB were enrolled. Seventy-one patients developed 59 hospital-acquired infections (HAI); the infection density being 36.2 infections per 1000 patient days. Invasive wound infections were the commonest (33), followed by blood stream infections (22), urinary tract infections (3) and pneumonia (1). Infection contributed to 75% of observed mortality. On logistic regression analysis, infected patients were more likely to die as well as stay longer in the hospital as compared to non-infected patients. Infected patients also had more central venous lines inserted. The mortality was related to percent TBSAB. Thirteen out of 18 patients who had TBSAB more than 60% died as compared to 5 out of 31 with TBSAB less than 40%. Staphylococcus aureus, Pseudomonas aeruginosa and beta-hemolytic streptococci (BHS) were the most frequent organisms causing hospital-acquired infection. Except for BHS all other organisms were highly drug resistant. Better compliance with hand washing and barrier nursing techniques, stricter control over disinfection and sterilization practices and usage of broad spectrum antibiotics, and reduction of the environmental contamination with S. aureus are required to reduce the HAI rates.

Objective: To document effects of intrapartum risk factors for early onset sepsis (EOS) on CRP levels in neonates and to assess the suitability of this test in diagnosing EOS., Design: Cohort study., Setting: Labour and post natal wards in a tertiary level teaching hospital in India., Subjects: 250 neonates at risk of developing infection., Methods: CRP levels in cord blood and neonatal blood at 24 hrs were estimated using commercial kits. Babies were observed for signs of sepsis for at least 48 hours., Results: Seven (2.8 Percent) neonates had elevated CRP levels in the cord blood. At 24 hours, 102 (40.8 Percent) babies had elevated levels. Elevated cord CRP levels was significantly associated with rupture of membranes for 24 hours (p =0.04), labour more than 12 hours (p = 0.002), and maternal fever (p = 0.01). At 24 hours, elevated CRP levels were associated with primiparity (p= 0.006), more than three vaginal examinations after membrane rupture (p=0.02), meconium staining of amniotic fluid (p =0.02) and amnioinfusion (p =0.02). Ten (4 Percent) babies developed EOS. The negative predictive value for elevated CRP levels at 24 h was 99 Percent., Conclusion: Several intrapartum risk factors for EOS can cause elevation in CRP levels. However, this test may be useful in excluding infection.

Perinatal risk factors were studied among 50 cases of neonatal septicemia and 200 matched normal neonates during one year period. The consanguinity among parents, birth order and sex of the baby did not increase the risk for developing septicemia. There was significant increase in the risk for septicemia when the duration of labour was more than 24 hours (P less than 0.01), time interval between rupture of membrane and delivery of baby was more than 12 hours (P less than 0.001), liquor was meconium stained or foul smelling (P less than 0.001) and delivery was operative (P less than 0.01). The neonatal factors identified with risk for septicemia were preterm delivery (P less than 0.01), low birth weight (P less than 0.01), birth asphyxia (P less than 0.001) assisted ventilation (P less than 0.001) and intravenous alimentation (P less than 0.02). Identification of high risk pregnancies and appropriate management can minimize many of the above risk factors which in turn will reduce the occurrence of neonatal sepsis.

Due to constraints in conducting specific tests for diagnosis of perinatal infection, the present study was carried out to find out the value of cord serum IgM levels as a screening procedure for intrauterine infection in full term intrauterine growth retarded (IUGR) babies. Thirty five consecutively born full term IUGR singleton babies and their mothers (having weight greater than 40 kg, height greater than 145 cm, Hb 8 g/dl and normal blood pressure) formed the study group. Ten full term singleton babies weighing greater than or equal to 3000 g and their mothers served as controls. In the study population both mean cord serum IgM (26.8 mg/dl) and mean maternal serum IgM (142.42 mg/dl) were raised as compared to the mean cord serum IgM (13.76 mg/dl) and mean maternal serum IgM (100.16 mg/dl) of the control group. However, statistically the rise was significant only between the maternal cord serum IgM levels. But all the same, cord serum IgM levels exceeding 20 mg/dl and 30 mg/dl were found in 51.43 and 22.8% of full term IUGR neonates, respectively whereas among the control neonates only 20.0% had levels exceeding 20 mg/dl and none had levels above 30 mg/dl suggesting possible intrauterine antigenic challenge to perinatal infection in higher proportion of IUGR babies. Cord serum IgM levels were also seen to increase with increase in birth weight. Idiopathic IUGR babies having cord serum IgM levels greater than 30 mg/dl should undergo specific immunological tests and follow up.