Emerging Antibiotic Resistance Patterns in a Neonatal Intensive Care Unit in Pune, India: A 2-Year Retrospective Study.

Objective: Treating neonatal bloodstream infections and meningitis in South Asia remains difficult given high rates of antimicrobial resistance (AMR). To evaluate changing epidemiology of neonatal infections, we assessed pathogen-specific and clinical features of culture-proven infections in neonates admitted to a neonatal intensive care unit (NICU) in Pune, India. Materials and Methods: This retrospective cohort study was performed in the King Edward Memorial Hospital and Research Center NICU over 2 years between January 1, 2017 and December 31, 2018. We included all neonates admitted to the NICU with positive blood or cerebrospinal fluid cultures. Demographic, clinical, and microbiologic data were collected from the medical record. We reviewed antimicrobial susceptibility testing (AST) of all isolates. Results: There were 93 culture-positive infections in 83 neonates, including 11 cases of meningitis. Fifteen (18%) neonates died. Gram-negative pathogens predominated (85%) and AST showed 74% resistance to aminoglycosides, 95% resistance to third/fourth generation cephalosporins, and 56% resistance to carbapenems. Resistance to colistin was present in 30% of Klebsiella pneumoniae isolates. Birth weight <1,000 g [odds ratio (OR) 6.0, p < 0.002], invasive respiratory support (OR 7.7, p = 0.001), and antibiotics at the time of culture (OR 4.2, p = 0.019) were associated with increased risk of mortality. Rates of AMR to all major antibiotic classes were similar between early onset and late onset infections. There was no association between carbapenem resistance and mortality. Conclusion: In our NICU in India, there are high rates of AMR among Gram-negative pathogens that are predominantly responsible for infections. Given higher colistin resistance in this cohort than previously reported, hospitals should consider routinely testing for colistin resistance.

Lung ultrasound (LUS) in pre-term neonates with respiratory distress: A prospective observational study.

Aim: To find out the diagnostic use of lung ultrasound (LUS) in respiratory distress in neonates by taking clinico-radiological (clinical plus X-ray) diagnosis as the gold standard. Secondary objectives were to find out if modified LUS score can predict the need for surfactant therapy. Methods: A prospective observational study was done in a tertiary care neonatal intensive care unit over a period of 1 year (January-December 2018). All pre-term infants with respiratory distress were screened with LUS and CXR within 2 h of admission and modified LUS score was calculated to find out the lung water content and its correlation with the severity of respiratory distress syndrome (RDS). Results: In total, 92 neonates were screened during the study period, and 61 were finally diagnosed as RDS. The Kappa statistic between the clinico-radiological diagnosis and LUS diagnosis was 0.639. LUS diagnosis and CXR diagnosis had a Kappa correlation value of 0.786 (95% CI: 0.678-0.983). The most common LUS feature in RDS was pleural line thickening (100%), followed by whiteout lungs (75.4%). The modified LUS score was higher in babies who needed surfactant therapy (median (IQR): 49 (44, 53.5) vs. 29.5 (21, 46)) (P < 0.0001). Conclusion: Our study shows that LUS in neonatal RDS can predict the severity of the disease, need for surfactant therapy and has good agreement with clinical and Xray diagnosis.

Implementation of the Comprehensive Unit-Based Safety Program to Improve Infection Prevention and Control Practices in Four Neonatal Intensive Care Units in Pune, India.

Objective: To implement the Comprehensive Unit-based Safety Program (CUSP) in four neonatal intensive care units (NICUs) in Pune, India, to improve infection prevention and control (IPC) practices. Design: In this quasi-experimental study, we implemented CUSP in four NICUs in Pune, India, to improve IPC practices in three focus areas: hand hygiene, aseptic technique for invasive procedures, and medication and intravenous fluid preparation and administration. Sites received training in CUSP methodology, formed multidisciplinary teams, and selected interventions for each focus area. Process measures included fidelity to CUSP, hand hygiene compliance, and central line insertion checklist completion. Outcome measures included the rate of healthcare-associated bloodstream infection (HA-BSI), all-cause mortality, patient safety culture, and workload. Results: A total of 144 healthcare workers and administrators completed CUSP training. All sites conducted at least 75% of monthly meetings. Hand hygiene compliance odds increased 6% per month [odds ratio (OR) 1.06 (95% CI 1.03-1.10)]. Providers completed insertion checklists for 68% of neonates with a central line; 83% of checklists were fully completed. All-cause mortality and HA-BSI rate did not change significantly after CUSP implementation. Patient safety culture domains with greatest improvement were management support for patient safety (+7.6%), teamwork within units (+5.3%), and organizational learning-continuous improvement (+4.7%). Overall workload increased from a mean score of 46.28 ± 16.97 at baseline to 65.07 ± 19.05 at follow-up (p < 0.0001). Conclusion: CUSP implementation increased hand hygiene compliance, successful implementation of a central line insertion checklist, and improvements in safety culture in four Indian NICUs. This multimodal strategy is a promising framework for low- and middle-income country healthcare facilities to reduce HAI risk in neonates.

LATCH Score at Discharge: A Predictor of Weight Gain and Exclusive Breastfeeding at 6 Weeks in Term Healthy Babies.

OBJECTIVES: World Health Organization recommends exclusive breastfeeding (EBF) for 6 months after birth. However, problems with the baby failing to latch properly are common in the postpartum period contributing to breastfeeding cessation. The aim of the study was to evaluate the utility of LATCH score to predict EBF and weight gain at 6 weeks postpartum along with an optimum LATCH score cutoff. PATIENTS AND METHODS: This prospective cohort study was conducted in India. Ninety-three mother-infant dyads at term gestation were enrolled. Two LATCH score assessments were done by a lactation consultant: first within 24 hours of birth and second at discharge. Mothers with low LATCH scores were counselled before discharge. EBF rate and weight gain velocity were analyzed at 6 weeks. RESULTS: LATCH score ≥6 at discharge has the highest sensitivity (92.1%) and specificity (66.7%) for predicting EBF at 6 weeks postpartum (RR, 95% CI; 5.63 [4.32-12.65], P = 0.0003). Receiver operating characteristic (ROC) of LATCH score at discharge and EBF at 6 weeks had an area under the curve of 0.785 with a cutoff ≥5.5, showing the highest sensitivity of 93.6% with a false-positive rate of 30.1%. LATCH score >6 at discharge was significantly associated with higher EBF rate (RR, 95% CI; 0.61 [0.39-0.94]) and appropriate weight gain (≥ 20 grams/day) at 6 weeks of age (RR, 95% CI; 0.44 [0.25-0.75]). After counselling, the LATCH score significantly improved at discharge in mothers (n = 62) with an initial score <6 (P < 0.001). CONCLUSION: LATCH score is a simple tool to identify mothers who require breastfeeding support and counselling before discharge from the hospital to prevent early breastfeeding cessation.

High Burden of Bloodstream Infections Associated With Antimicrobial Resistance and Mortality in the Neonatal Intensive Care Unit in Pune, India.

BACKGROUND: Antimicrobial resistance (AMR) is a growing threat to newborns in low- and middle-income countries (LMIC). METHODS: We performed a prospective cohort study in 3 tertiary neonatal intensive care units (NICUs) in Pune, India, to describe the epidemiology of neonatal bloodstream infections (BSIs). All neonates admitted to the NICU were enrolled. The primary outcome was BSI, defined as positive blood culture. Early-onset BSI was defined as BSI on day of life (DOL) 0-2 and late-onset BSI on DOL 3 or later. RESULTS: From 1 May 2017 until 30 April 2018, 4073 neonates were enrolled. Among at-risk neonates, 55 (1.6%) developed early-onset BSI and 176 (5.5%) developed late-onset BSI. The majority of BSIs were caused by gram-negative bacteria (GNB; 58%); among GNB, 61 (45%) were resistant to carbapenems. Klebsiella spp. (n = 53, 23%) were the most common cause of BSI. Compared with neonates without BSI, all-cause mortality was higher among neonates with early-onset BSI (31% vs 10%, P < .001) and late-onset BSI (24% vs 7%, P < .001). Non-low-birth-weight neonates with late-onset BSI had the greatest excess in mortality (22% vs 3%, P < .001). CONCLUSIONS: In our cohort, neonatal BSIs were most commonly caused by GNB, with a high prevalence of AMR, and were associated with high mortality, even in term neonates. Effective interventions are urgently needed to reduce the burden of BSI and death due to AMR GNB in hospitalized neonates in LMIC.

Ionizing Radiation Exposure in NICU.

The authors prospectively studied ionizing radiation exposure in consecutive 107 very low birth weight (VLBW) neonates, admitted to their Level III neonatal intensive care unit (NICU). Number of X-rays, their indications and calculated dose of radiation were documented. Their mean birth weight (+SD) and gestational age (+SD) were 1077 (±219.8) g and 29.7 (+2.57) wk respectively. Extremely low birth weight (ELBW) neonates underwent significantly higher radiographs when compared with VLBW neonates; 7.5(5-13.25) vs. 2(1-6); p < 0.0001. ELBW neonates received 3 times higher dose of radiation, when compared with VLBW neonates; 139.4 µsv (81.6-256.15) vs. 46.6 µsv (14.4-115.7); p < 0.0001. Seven percent of ELBW neonates received >1msv radiation. Lifetime risk associated with high radiation exposure during neonatal period is unknown. Every effort should be taken to reduce number of radiographs. Imaging modalities without radiation exposure such as, point of care ultrasound should be used wherever possible.

Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.

Fluconazole prophylaxis against fungal colonization and invasive fungal infection in very low birth weight infants.

BACKGROUND: Fungal infections are common cause of morbidity and mortality in very low birth weight Infants OBJECTIVES: To evaluate the efficacy of prophylactic Fluconazole in preventing fungal colonization and invasive fungal infection in VLBW infants. DESIGN: Prospective, randomized, double blind placebo controlled clinical trial. SETTING: Tertiary level Neonatal intensive care unit. SUBJECTS: 120 preterm infants with birth Weight < 1500 g. INTERVENTION: Infants were randomly assigned during first three days to receive either Fluconazole or placebo till 28 days or less if, discharged or died earlier. Weekly surveillance cultures from groin, oropharynx, rectum and blood were collected in all patients. Fungal isolates were typed based on standard microbiologic techniques. Liver enzymes were monitored. RESULTS: Baseline risk factors for fungal infection in Fluconazole and Placebo groups were similar. Fungal colonization was seen in 30 infants (50%) in the placebo group and 11 infants (19%) in the Fluconazole group (P <0.001). Fungal colonization at rectum, groin and oropharynx was less in fluconazole groups. Fluconazole group showed significantly lower colonizations with Candida albicans but not with C. glabrata. Invasive infection was seen in 15 (25%) infants in Placebo group and 16 (26.7%) infants in Fluconazole group (P = 0.835). Various non-albicans Candida were responsible for 96.8% cases of invasive fungal infection (Candida glabrata 71%, C. parapsilosis 14.7% and C. tropicalis 9.6%). No significant hepatotoxicity was noticed during Fluconazole therapy. CONCLUSION: Prophylactic fluconazole during the first four weeks of life is effective in reducing fungal colonization but not invasive infection in VLBW infants.

Noma neonatorum.

Noma Neonatorum is characterized by a gangrenous process involving mucocutaneous junctions of oral, nasal and anal area and occasionally, the eyelids and scrotum. It is seen during the first few weeks of neonatal life in premature and low birth weight babies. Noma Neonatorum is commonly described with pseudomonas aeruginosa septicemia. A case of Noma Neonatorum associated with E.coli sepsis is described for the first time.

Sirenomelia apus with vestigial tail.

Sirenomelia is an exceptionally rare congenital malformation characterized by complete or near complete fusion of lower limbs. A newborn with clinical features of sirenomelia including fused lower limbs in medial position, absent fibula, anal atresia, complete absence of urogenital system (bilateral renal agenesis, absent ureters, urinary bladder, absent internal and external genitalia), a single umbilical artery and a vestigial tail is reported. Association of vestigial tail with sirenomelia is not described in the literature.

Fanconi's anemia in newborn.

Fanconi's anemia (FA) is a paradigm for congenital anomalies, aplastic anemia and predisposition to malignancies. Identification of the disease at birth is based on characteristic physical malformations, as hematologic manifestations at birth are extremely rare. We report a case of FA in a newborn who presented with anophthalmia, unilateral radial ray defect, hemivertebrae and thrombocytopenia.