Complications of Hypertriglyceridemia in Pregnancy and Its Impact on Neonates: a Hospital-Based Study From Odisha.

Objective Hypertriglyceridemia (HTG) in pregnancy causes an increased risk for maternal and fetal complications. But, reports on the impact of HTG in pregnancy on maternal and fetal outcomes are scarce in developing countries. We aim to determine the maternal and neonatal complications of HTG in pregnancy. Materials and methods This prospective observational study was conducted on 150 pregnant women with HTG in the department of obstetrics and gynecology, KIMS, Bhubaneswar, from December 2019 to November 2020. Measurement of triglycerides during the first trimester, second trimester, and delivery was done. Maternal complications and neonatal outcomes in HTG mothers and mothers with normal triglyceride levels were compared. Results Out of 150 HTG cases, hypothyroidism, preeclampsia, acute pancreatitis, and sickle cell crisis occurred in 41 (27.3%), 22 (14.7%), six (4%), and three (2%) cases, respectively. The triglyceridemia (TG) levels raised from 133.7±48.2 mg/dl in the first trimester to 232.8±151.0 mg/dl in the third trimester. There is a significant increase in TG levels at the time of delivery compared to the first and second trimesters (p< .001). Out of 140 neonates, 30 (21.4%) were preterm, eight (5.7%) had intrauterine growth restriction (IUGR), and four (6.06%) were macrosomic. Intrauterine death, preterm, and macrosomia are significantly associated with maternal HTG compared to normal mothers (p < .032). All mortalities were due to acute pancreatitis (6; 4%) among mothers and four intrauterine fetal death. Conclusion There is a steady increase in TG levels in the successive trimesters of pregnancy. Gestational severe hypertriglyceridemia causes life-threatening complications. HTG-induced acute pancreatitis needs to be managed aggressively to prevent maternal death. Neonates of HTG mothers suffer from complications like prematurity, IUGR, and macrosomia.

Bacteriological Profile and Outcome of Culture-Positive Neonatal Sepsis in a Special Newborn Care Unit Setting, Odisha.

INTRODUCTION: Nearly one-third of neonatal mortality in India is due to neonatal sepsis and death occurs in 30% of culture-positive neonates. Pathogens such as Klebsiella pneumoniae and Escherichia coli are the most common bacteria responsible for neonatal sepsis in India and South Asia. MATERIALS AND METHODS: It was an observational study, conducted in special newborn care units (SNCUs) of Capital Hospital in Bhubaneswar, Odisha from May 2017 to October 2019. All neonates (<28 days of life) with blood culture-positive sepsis were included in this study. Blood cultures were sent in all the babies with features of clinical sepsis. The demographic profile of neonates, clinical presentations, isolated organisms, and their sensitive patterns was recorded for analysis. RESULTS: Blood culture was sent in 445 suspected neonates with clinical sepsis out of which 115 blood culture positive organisms were isolated. Among the isolated organisms, 42 (35.6%) cases were Staphylococcus aureus followed by Coagulase negative Staphylococcus (CONS) (20.8%), E. coli (19.1%), K. pneumoniae (10.4%), Acinetobacter baumannii (2.7%), Enterobacter spp.(4.3%), Enterococcus spp. (4.3%), and Pseudomonas aeruginosa (2.7%). S. aureus was the predominant organism found in both early and late-onset sepsis. All Gram-negative bacilli (GNB) are resistant to ampicillin whereas cephalosporin resistance was found in 68% of cases. Mortality due to sepsis was 8%. CONCLUSION:  S. aureus followed by CONS was found to be the most common cause of sepsis in SNCU. A high degree of resistance of organisms to penicillins and cephalosporins calls for a re-evaluation of antibiotic policy and protocols for empirical treatment in neonatal sepsis.

Comparison of Hematological and Biochemical Parameters of SARS-CoV-2-Positive and -Negative Neonates of COVID-19 Mothers in a COVID-19 Hospital, Odisha State.

Introduction Data are scarce on the hematological and biochemical changes caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in neonates. This study aimed to compare hematological and biochemical parameters in SARS-CoV-2-positive neonates with healthy neonates born to mothers diagnosed with coronavirus disease 2019 (COVID-19) and assess disease severity in both groups. Methodology  This prospective observational study was conducted at a COVID-19 hospital at Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India, from May 1 to November 30, 2020. Forty-eight babies, including 39 inborn and nine outborn, were enrolled in the study after their parents provided written informed consent. Neonates were diagnosed with COVID-19 via nasopharyngeal real-time reverse transcription-polymerase chain reaction testing. The hematological and biochemical parameters of these 48 neonates were recorded and analyzed. Results  SARS-CoV-2-infected neonates had lower hemoglobin, neutrophil to lymphocyte ratio, total white blood cell count, and absolute neutrophil count compared to noninfected babies (p<0.05). All SARS-CoV-2-infected neonates had serum transaminase levels and renal function tests within reference ranges. We saw no significant differences in hematological and biochemical parameters among asymptomatic SARS-CoV-2-infected and noninfected neonates.  Conclusions Hematological and biochemical parameters between asymptomatic SARS-CoV-2-infected and non-infected neonates were similar. The blood count abnormalities found in SARS-CoV-2-infected neonates could be due to other associated neonatal comorbidities. According to our results, asymptomatic SARS-CoV-2-infected newborns need close monitoring rather than a battery of investigation.

Hospital-Based Prevalence, Electroencephalogram (EEG), and Neuroimaging Correlation in Seizures Among Children in Odisha, India.

BACKGROUND: Febrile seizures are very common in pediatric practice. We need to differentiate between febrile seizures and other seizures due to central nervous system (CNS) infection by various means of investigation. Though approximately 30% of patients with febrile seizure have later epilepsy and the risk is around 20% even if electroencephalogram (EEG), and neuro-imagings are normal. But data regarding this is laking in developing countries like India. AIM: The primary objective of this study is to determine the hospital-based prevalence among various types and etiologies of seizures in children admitted to the pediatric department in a teaching hospital of a developing country, India. Besides, the different types of seizures were correlated with the EEG and neuroimaging findings along with the acute onset of seizures among children. METHODS: In this prospective observational study, children from two months to 15 years of age admitted to the Pediatrics Department, KIMS, Bhubaneswar in India between September 2017 and September 2019 were taken. The patients having seizures were included in the study based on the inclusion criteria. Neurological and systemic examinations of the children were recorded and the neuroimaging reports were analyzed. RESULTS: A total of 19,553 patients aged two months to 15 years were admitted during the study period. Of that, 1,192 cases were diagnosed with febrile and unprovoked seizures. It was observed that the hospital-based prevalence of seizures among children in Odisha was 6%. Besides, it is found that generalized seizure disorder was the most common among the children. It was found that abnormal EEG, magnetic resonance imaging (MRI), and computed tomography (CT) brain in 60% (202/340), 49% (113/230), and 47% (136/288) of cases, respectively. MRI is a better modality of investigation in partial seizure cases 22 (64%) to detect CNS abnormality. Also, MRI of the brain is better in evaluating CNS abnormality in complex febrile cases 4 (31%) than CT brain (0%). CONCLUSION: The study concluded that EEG must be the standard modality of test for patients' diagnosis of seizure in children with seizures. CT/MRI scan can give a better supplement to the results but MRI findings are more accurate in cases of complex febrile seizures.

MRI Abnormalities of the Brain After Complex Febrile Seizures in Children.

Background Though simple febrile seizures do not cause significant and lasting neurological deficits, complex febrile seizures (CFS) can result in neurologic sequelae. Because CFS causes cortical focal injuries and other brain lesions, it needs to be evaluated. Objective The objective of this study was to evaluate the MRI brain changes in CFS, the incidence of seizures in children aged six months to five years, and their severity in relation to MRI findings of the brain. Methods In this observational study, 36 children aged six months to five years, having fever with seizure, and fulfilling the criteria of CFS were enrolled within 48 hours of the episode. Detailed clinical and neurological examinations were performed with MRI scans to find out the probable CNS lesions of CFS. Two radiologists separately evaluated all MRI brains. Results MRI lesions of the brain were found in 11 (30.56%) CFS patients. Generalized tonic-clonic seizures (GTCS) (n=31, 86.11%) were the most common type of seizure among CFS cases. Cortical focal hyperintensity (CFH) (42.1%) was the most common MRI presentation. Positive MRI findings were significantly associated with focal convulsions (n=5, 100%) as compared to GTCS cases (n=6, 19%) (p=0.001). Conclusions CFH is the most common abnormality in the MRI brain among CFS cases. CFS patients with focal seizures or prolonged seizures in 24 hours have higher abnormal neuroimaging findings. MRI should be considered a preferred investigatory tool for detecting CNS pathology in CFS cases. Follow-up studies are needed to determine the long-term outcomes of CNS lesions in children with CFS.

Adverse Drug Reactions in the Pediatric Population: Findings From the Adverse Drug Reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020).

Background and objective The incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India. Methods This was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis. Results The largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent. Conclusions One-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.

Risk and Adverse Outcome Factors of Severe Acute Malnutrition in Children: A Hospital-Based Study in Odisha.

Background  Malnutrition is prevalent in 41% of children less than five years old in developing countries. Objective To determine the clinical spectrum, identify the risk factors, and find out the factors responsible for the adverse outcomes of severe acute malnutrition (SAM) in children. Methods In this prospective cohort, children aged one month to five years with SAM from October 2016 to September 2018 were enrolled. Clinical profile, contributing factors, treatment, and outcome of cases (n=198) were noted. Results SAM was diagnosed in 323 (1.6%) of admitted cases. The unimmunized children were 123 (62.1%). Common co-morbidities were acute gastroenteritis (n=89, 44.9%), respiratory tract infection (n=88, 44.4%), and septicemia (n=54, 26.7%). Children not on exclusive breastfeeding (n=157, 79.1%), early complementary feeding (<6 months) (n=157, 88.2%), bottle-feeding (n=138, 77.55%), low birth weight (157, 79.1%), living in kutcha houses (115, 58.2%), and unavailability of safe drinking water (131, 66.4%) were the significant risk factors. Pneumonia, diarrhea, nutritional edema, hypothermia, and circulatory shock at the time of admission were responsible for adverse outcomes. One hundred and eighty-three (92.4%) children were cured and discharged and 15 (7.6%) children died. Conclusions Wrong feeding practices and unavailability of safe drinking water have an important bearing on the development of SAM children. Pneumonia, diarrhea, nutritional edema, hypothermia, and circulatory shock at the time of admission were responsible for adverse outcomes.

Rotavirus Strain Distribution before and after Introducing Rotavirus Vaccine in India.

In April 2016, an indigenous monovalent rotavirus vaccine (Rotavac) was introduced to the National Immunization Program in India. Hospital-based surveillance for acute gastroenteritis was conducted in five sentinel sites from 2012 to 2020 to monitor the vaccine impact on various genotypes and the reduction in rotavirus positivity at each site. Stool samples collected from children under 5 years of age hospitalized with diarrhea were tested for group A rotavirus using a commercial enzyme immunoassay, and rotavirus strains were characterized by RT-PCR. The proportion of diarrhea hospitalizations attributable to rotavirus at the five sites declined from a range of 56-29.4% in pre-vaccine years to 34-12% in post-vaccine years. G1P[8] was the predominant strain in the pre-vaccination period, and G3P[8] was the most common in the post-vaccination period. Circulating patterns varied throughout the study period, and increased proportions of mixed genotypes were detected in the post-vaccination phase. Continuous long-term surveillance is essential to understand the diversity and immuno-epidemiological effects of rotavirus vaccination.

Clinico-Biochemical Correlation in Birth Asphyxia and Its Effects on Outcome.

Background Birth asphyxia is a major cause of early neonatal death and leads to severe consequences such as epilepsy, cerebral palsy, and developmental delay. This study aims to determine the correlation between dyselectrolytemia and the degree of hypoxic-ischemic encephalopathy (HIE) and to find out major risk factors contributing to the severity of HIE and neonatal death. Methods In this prospective cohort study (n=150), term babies weighing ≥ 2.5 kg at birth, with the diagnosis of birth asphyxia, admitted in a medical college in Odisha state from September 2014 to August 2016 were included. Clinical findings, biochemical parameters, treatment, and outcome of HIE babies were recorded. Result The majority of the asphyxiated babies were having moderate HIE (HIE II) (57.33%), whereas mild and severe stages were seen in 15.33%, and 27.34% of babies, respectively. Factors like prolonged labor (87.8%) and meconium-stained liquor (63.4%) were mostly attributed to the severe degree of birth asphyxia (p < 0.001). Apnea, lethargy, and hypothermia were the most remarkable feature of HIE III. The degree of hyponatremia, hypocalcemia, and hyperkalemia (124.4±4.4 mmol/l, 0.83±0.08 mmol/l, and 6.17± 0.89 mmol/l, respectively) were more severely affected in HIE III as compared to HIE l (137.5±3.8 mmol/l, 1.06±0.17 mmol/l, and 5.0±0.79 mmol/l, respectively). Serum urea and creatinine increased proportionately with an increase in the severity of HIE grade. The mildly asphyxiated neonates recovered completely, whereas all the cases who died (n=29,19.3%) belonged to the moderate or severe degree of birth asphyxia. Conclusion The asphyxiated neonates had hyponatremia, hypocalcemia, hyperkalemia, raised serum urea, and creatinine and correlated with the severity of birth asphyxia. Prolonged labor and meconium-stained liquor were the most attributable factor for the severe degree of birth asphyxia. Effective neonatal resuscitation and quick correction of electrolyte imbalances will help in the reduction of neonatal mortality and long-term neurological sequelae.

Clinical Feature and Outcome of Childhood Status Epilepticus in a Teaching Hospital, Odisha, India.

Objectives The main aim is to find out the clinical feature and outcome of status epilepticus (SE) in children managed in a teaching hospital. The secondary aim is to identify the risk factors influencing the adverse outcomes. Methods In this prospective cohort, children aged 1 month to 14 years with SE as per the International League Against Epilepsy's new guideline (2016) who presented to the emergency department during the period of November 2017 to October 2019 were enrolled. Clinical profile, treatment, and outcome of cases (n = 94) were noted. Results The majority of children, 60 (63.82%), were less than five years of age. Prior history of seizures was present in 33 (35.1%) cases, whereas 61 (64.9%) cases presented with SE as the first episode of seizure. In 14 (42.4%) previous seizure cases, SE was due to drug default. No response to first-line antiepileptic drug (AED) was seen in 84 (89.37%) cases. Acute symptomatic etiology was the commonest etiology of SE in 64 (68%) cases, of which neuro-infections accounted for 44 (46.80%) cases. Longer duration (>60 minutes) of status (p < 0.01), ventilator support (p < 0.0001), and circulatory impairment (p < 0.0001) were attributable risk factors for mortality. A total of 28 children died (mortality rate, 29.8%), and 11 showed the persistence of their neuro-deficit. Conclusions Neuro-infection is the most common etiology of SE in children. Longer duration of SE, more lag time for receiving the first AED, respiratory failure, and presence of shock are independent predictors for poor outcome. Hence, cessation of convulsion at the earliest leads to improved outcomes.

Intussusception after Rotavirus Vaccine Introduction in India.

BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

An Assumed Vertical Transmission of SARS-CoV-2 During Pregnancy: A Case Report and Review of Literature.

The ongoing coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has affected persons of all ages, including the newborns. Few published case reports and case series have described the possibility of vertical transmission of COVID-19. In the present report, we describe a young primigravida at 33 weeks of gestation, who presented with a four-day history of low-grade fever, malaise, and breathing difficulty. She underwent testing of nasopharyngeal swab sample by real-time polymerase chain reaction (RT-PCR), which was positive for COVID-19. Cesarean section was done, and a preterm low birthweight baby was delivered. The baby required resuscitation at birth and was mechanically ventilated for a shorter duration. A tracheal aspirate that was taken at 12 hours of life tested positive for COVID-19. The course and outcome of the newborn are described here along with the possibility of vertical transmission.

Coronavirus Disease 2019 in Neonates - What Is Known and What Needs to Be Known.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first broke out in Wuhan, China, and subsequently spread worldwide affecting all ages including newborns. The cases of coronavirus disease 2019 (COVID-19) are very less in neonates and they recover well with supportive treatment. Though the vertical transmission of infection is scarcely found, to get rid of acquiring infection by horizontal transmission one should screen all pregnant women and ensure standard infection control measures and monitoring of newborns at risk of COVID-19. Neonates may present as a refusal to feed, feeding intolerance, fever, pneumonia, shortness of breath, and lethargic. Based on available evidence, antivirals like lopinavir, ritonavir, remdesivir specific medication like chloroquine/hydroxychloroquine, azithromycin, corticosteroids, and intravenous gamma globulin, are not recommended, so early detection and supportive treatment is needed for an optimal outcome.

Vaccine development for enteric bacterial pathogens: Where do we stand?

Gut infections triggered by pathogenic bacteria lead to most frequently occurring diarrhea in humans accounting for million deaths annually. Currently, only a few licensed vaccines are available against these pathogens for mostly travelers moving to diarrheal endemic areas. Besides commercialized vaccines, there are many formulations that are either under clinical or pre-clinical stages of development and despite several efforts to improve safety, immunogenicity and efficacy, none of them can confer long-term protective immunity, for which repeated booster doses are always recommended. Further in many countries, financial, social and political constraints have jeopardized vaccine development program against these pathogens that enforce us to gather knowledge on safety, tolerability, immunogenicity and protective efficacy regarding the same. In this review, we analyze safety and efficacy issues of vaccines against five major gut bacteria causing enteric infections. The article also simultaneously describes several barriers for vaccine development and further discusses possible strategies to enhance immunogenicity and efficacy.