Ten- vs. 14-day antibiotic therapy for culture-positive neonatal sepsis.

BACKGROUND: Neonatal sepsis is a major determinant of neonatal mortality. There is a scarcity of evidence-based guidelines for the duration of antibiotics in culture-positive sepsis. OBJECTIVES: The aim of this study was to compare the efficacy of 10- and 14-day antibiotic therapies in the management of culture-positive neonatal sepsis. METHODS: This randomized controlled trial was conducted in the neonatal intensive care unit of a tertiary care center among the neonates suffering from culture-positive sepsis (with signs of clinical remission on day 9 of antibiotic) between January 2023 and May 2023. Newborns with major congenital anomaly, deep-seated infections, multi-organ dysfunction, associated fungal infections/infection by multiple organisms and severe birth asphyxia were excluded. Two hundred and thirty-four newborns were randomized into two groups-study (received 10 days of antibiotics) and control (received 14 days of antibiotics). Treatment failure, hospital stay and adverse effects were compared between the two groups. p < 0.05 was taken as the limit of statistical significance. RESULTS: Median [interquartile range (IQR)] birth weight and gestational age of the study population (53.8% boys) were 2.424 kg (IQR: 2.183-2.695) and 37.3 weeks (IQR: 35.5-38.1), respectively. Acinetobacter was the most commonly isolated species (56, 23.9%). The baseline characteristics of both groups were almost similar. Treatment failure was similar in the study and control groups (3.8% vs. 1.7%, p = 0.40), with a shorter hospital stay [median (IQR): 14 (13-16) vs. 18 (17-19) days, p < 0.001]. CONCLUSION: Ten-day antibiotic therapy was comparable with 14-day antibiotic therapy in efficacy, with a shorter duration of hospital stay and without any significant increase in adverse effects.

Neonatal sepsis is a major cause of neonatal mortality in developing countries like India. Textbooks recommend 14-day antibiotic treatment for culture-positive neonatal sepsis. However, these guidelines are not strictly evidence based. Prolonged antibiotic treatment might be associated with drug resistance, secondary infections and organ damage. A shorter course of antibiotic, if found effective, would be beneficial especially in the resource-constrained settings like India. Hence, this study was undertaken to compare a shorter duration antibiotic treatment (10 days) with the conventional 14-day antibiotic therapy. Two hundred and thirty-four newborns with culture-positive sepsis were randomized into the study group (received 10 days of antibiotics) and the control group (received 14 days of antibiotics). Socio-demographic characters, clinical and laboratory features and bacteriological profile of both the groups were recorded. Both the groups were comparable in baseline features. Two-thirds of them were suffering from Gram-negative sepsis, Acinetobacter being the most commonly isolated organism. Incidence of treatment failure was similar in the study and control groups. Duration of hospital stay was significantly lower in the study group than in the control group. This observation was true irrespective of gestational age and type of organisms. There were no significant differences in adverse effects between the groups. However, there are certain limitations in the study, and hence, multi-centric research should be undertaken before making generalized recommendations of practising short duration of antibiotics.

Clinical Profile and Short-Term Outcome of SARS-CoV-2-Infected Neonates from a Government Medical College in West Bengal, India.

INTRODUCTION: Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) has led to a terrifying global pandemic. The presentations in neonates are varied with less case severity compared to adults. AIM: To describe the clinical and laboratory features and outcomes of neonates admitted with SARS-CoV-2 infection during the second surge of COVID-19 pandemic in a Government Medical College, West Bengal, India. MATERIALS AND METHODS: It is a hospital-based observational cross-sectional study conducted in the newborn unit of Burdwan Medical College and Hospital between 1 April 2021 and 31 July 2021 including all SARS-CoV-2 Real time RT-PCR (Reverse transcriptase polymerase chain reaction) positive neonates. The demographic, clinical and laboratory characteristics of all the neonates and their outcomes were documented and analysed. RESULTS: Twenty-two neonates were found to be SARS-CoV-2 RT-PCR positive out of which 9 (40.9%) were found to be asymptomatic and 6 (27.27%) required neonatal intensive care unit admissions. Among the symptomatic neonates, most common presentations were respiratory distress (40.9%) and gastrointestinal manifestations (40.9%). Eight (36.36%) neonates required respiratory support. Three (13.6%) neonates had pneumonia of which one had right middle lobe collapse. Laboratory parameters were nonspecific except for the two (9%) cases of multisystem inflammatory syndrome in neonates. High-resolution computed tomography findings in two cases were suggestive of SARS-CoV-2 infection-induced changes. Two (9%) neonates died of which one was likely due to SARS-CoV-2 infection. CONCLUSION: Neonates with SARS-CoV-2 infection are mostly asymptomatic. However, clinicians must be vigilant as atypical presentations such as consolidation, collapse, meningitis or multisystem inflammatory syndrome may occur.

SARS-CoV-2 infection in neonates is rare with varied presentations ranging from asymptomatic neonates to a few presenting with multiorgan failure. The disease severity and case fatality are much less than in adults. We studied the clinical and laboratory features and outcomes of 22 neonates with SARS-CoV-2 infection during the second surge of COVID-19 pandemic. While nine (40.9%) neonates were asymptomatic, six (27.27%) required NICU admission. Pneumonia is a rare presentation in neonates but severe COVID-19 pneumonia resulting in consolidation and lobar collapse requiring positive pressure ventilation is a possibility. Multisystem inflammatory syndrome in neonates is also a clinical entity probably as a result of hyperinflammatory syndrome due to transplacental transfer of antibodies. They require rigorous treatment, close monitoring and regular follow-ups. Amniotic fluid, placental or cord blood testing is essential to ascertain the definite mode of transmission in these neonates.

Effectiveness and adverse drug reactions of levetiracetam and midazolam in refractory neonatal seizure: A cross-sectional comparative study.

BACKGROUND: Neonatal seizure (NS) reflects serious underlying brain injury, requiring immediate evaluation and early treatment. In neonates, phenobarbitone and phenytoin are used primarily to control the seizures. If uncontrolled, widespread off-label use of midazolam and levetiracetam was practiced. These drugs gained popularity though there are no such studies available on literature search comparing them. The present study was designed to explore these lacunae using these two drugs in refractory cases. To study the efficacy and adverse drug reactions (ADRs) of midazolam and levetiracetam not responding to usual line of therapy. MATERIALS AND METHODS: This was a prospective cross-sectional study conducted on 69 neonates in the NICU and Department of Pharmacology in Burdwan Medical College and Hospital, West Bengal. Patients receiving midazolam or levetiracetam when uncontrolled with first line antiepileptics, namely, phenobarbitone and phenytoin, were considered eligible. The study variables were time to control seizure, seizure recurrence and frequency, and treatment-related adverse events. analysis used Mann-Whitney U-test were applied Comparison with respect to time to control and Chi-square test were applied to detect difference in proportion for ADRs. The SPSS Statistics 17.0 was used for analysis. RESULTS: We compared the time periods to control neonatal seizure for effectiveness between levetiracetam and midazolam showing no significant difference (P = 0.190). Comparing the portion of recurrences in two groups gives statistically nonsignificant (P = 0.878) result. Only respiratory depression was seen in the levetiracetam group (12.90%) and midazolam group (18.42%). All adverse events were 'probable' as per the WHO-UMC criteria, and there was no statistically significant difference between the two drugs (P = 0.533). CONCLUSIONS: Both midazolam and levetiracetam are equally effective and safe in NS not responding to usual line of treatment.

A Comparative Study on Intranasal Versus Intravenous Lorazepam in the Management of Acute Seizure in Children.

INTRODUCTION: The acute seizure in childhood is a medical emergency which is usually managed by benzodiazepines used as a first line of therapy. There are no strict guidelines of using intranasal lorazepam in India. Many paediatricians use it in an emergency situation as it is inexpensive, easy to administer and even treatment can be started at home. Very few studies are available to compare efficacy and safety of intravenous lorazepam with intranasal lorazepam in childhood seizure, though both routes have comparable pharmacokinetic profile. Intravenous lorazepam (0.1 mg/kg) is already recommended as a first-line treatment of acute childhood seizures in India. There are very few studies regarding the usefulness of intranasal lorazepam. With this background, we compared intranasal lorazepam with the more widely accepted intravenous lorazepam for control of acute seizure. AIM: To compare effectiveness and safety of intranasal and intravenous lorazepam in acute seizure in children aged 5-12 years. MATERIALS AND METHODS: This is an analytical observational cross-sectional study involving patients with acute seizure who received lorazepam via either the intravenous or intranasal route. Formulation and dosage of lorazepam were the same in both routes. RESULTS: Distributions of patient groups according to sex, age, and weight were statistically not significant (p=0.42, p=0.391, and p=0.605, respectively). Time to control seizure within 10 min and persistent cessation of seizure activity were similar in both groups. Safety parameters showed no differences statistically. CONCLUSIONS: Though intravenous lorazepam is recommended as first-line treatment, intranasal lorazepam may be a good alternative choice in a convulsing child.

Effect of Virgin Coconut Oil Application on the Skin of Preterm Newborns: A Randomized Controlled Trial.

BACKGROUND: Preterm constitutes a major part of neonatal mortality, particularly in India. Due to dermal immaturity, preterm neonates are susceptible to various complications like infection, hypothermia, etc. Emollient application is a traditional practice in our subcontinent. AIMS: To find out the efficacy of coconut oil application for skin maturity, prevention of sepsis, hypothermia and apnea, its effect on long-term neurodevelopment and adverse effect of it, if any. MATERIAL AND METHODS: A randomized controlled trial was conducted in the rural field practice area of Department of Community Medicine, Burdwan Medical College from March 2014 to August 2018. Preterm born in the study period was divided into Group A (received virgin coconut oil application) and Group B (received body massage without any application). Neonatal skin condition was assessed on 7th, 14th, 21st and 28th day of life. Neurodevelopmental status was assessed on 3rd, 6th and 12th months. RESULTS: A total of 2294 preterm were included in the study. Groups A and B consisted of 1146 and 1148 preterm infants, consecutively. Mean gestational age of the study population was 31.9 ± 3.4 weeks and 50.4% were male. Mean weight loss in first few days was less in group A but mean weight gain per day was higher in group B. Lesser incidences of hypothermia and apnea, and better skin maturity and neurodevelopmental outcome were noted in group A. No significant adverse effect was noted with coconut oil application. CONCLUSION: Use of coconut oil helps in dermal maturity and better neurodevelopmental outcome. Further studies are warranted for universal recommendation.

Efficacy of Arsenicum album 30cH in preventing febrile episodes following DPT-HepB-Polio vaccination - a randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: Among the post-immunization adverse events, especially of Diphtheria-Pertusis-Tetanus (DPT), fever is a common systemic reaction. There is anecdotal support for the use of the homeopathic medicine Arsenicum album in preventing post-vaccination fever. The investigators intended to evaluate its efficacy in preventing febrile episodes following vaccination. METHODS: In the community medicine out-patient of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, West Bengal, India, between August 2014 and January 2017, a double-blind, randomized, placebo-controlled trial was conducted on 120 children (verum: 60, placebo: 60) who presented for the 2nd and 3rd dose of DPT-HepB-Polio vaccination and reported febrile episodes following the 1st dose. Intervention used was Arsenicum album 30cH 6 doses or placebo (indistinguishable from verum), thrice daily for two subsequent days. Parents were advised to report any event of febrile attacks within 48h of vaccination, either directly or over telephone. RESULTS: The groups were comparable at baseline. Children reporting fever after the 2nd dose was 29.8% and 30.4% respectively for the homeopathy group and control group respectively [Relative Risk (RR)=1.008] with no significant difference (P=0.951) between groups. Again after the 3rd dose, children reporting fever were 31.5% and 28.3% respectively for the homeopathy group and control group respectively (RR=0.956) with no significant difference (P=0.719) between groups. CONCLUSION: Empirically selected Arsenicum album 30cH could not produce differentiable effect from placebo in preventing febrile episodes following DPT-HepB-Polio vaccination. [Trial registration: CTRI/2017/02/007939].

Assessment of normal portal vein diameter in children.

BACKGROUND AND AIM: The internal diameter of the portal vein varies with age and anthropometric parameters. The caliber of the normal portal vein in adults has been extensively studied but little is known about portal vein dimensions in the growing child. This study was conducted to establish standards of portal vein diameter by ultrasonography in healthy Indian children based on age, gender and anthropometric parameters. METHODS: Total 306 healthy children between the age of < 1 month and 12 years, visiting our outpatient departmentor accompanying their siblings were enrolled in the study. The children were distributed into ten age-groups. Each group was further divided in two sub-groups based on gender. Anthropometric parameters including weight, height and chest circumference were measured.Portal vein diameter was assessed by ultrasonography. RESULTS: The portal vein diameter increases with age, height, weight and chestcircumference. But the values are similar in boys and girls. Multiple logistic regression (adjusted R- square: 0.922) revealed age (p = 0.002), height/length (p < 0.0001), weight (p = 0.011), and chest circumference (p < 0.0001), as independent determinants of portal vein diameter. However, height/length emerged as the most consistent determinant (coefficient of regression: 1.536; p < 0.001; 95% confidence interval: 0.066-0.092). CONCLUSION: Our results provide a normal range of portal vein diameter according to age, gender and anthropometric parameters. We conclude that portal vein diameter strongly correlates with age and anthropometric variables like height, weight and chestcircumference,with height being the strongest determinant.

Umbilical myiasis in newborn.

Umbilical myiasis is rare in newborns. We are reporting two cases of umbilical myiasis from rural West Bengal (India) that were infected by larval forms of blow fly (Chrysomya megacephala). One of them subsequently developed septicemia while the other one was clinically well.

Hydatid cyst in rectus abdominis muscle in a child: An unusual occurrence.

Hydatid cysts usually involve the liver; extrahepatic localization is reported in 11% of all cases of abdominal hydatid disease. Cyst at unusual localization includes kidney, heart, spleen, pancreas and brain. Isolated involvement of muscle is also rare in children. Here is a case of hydatid cyst in a female child involving the rectus abdominis muscle, which is a very rare presentation. There were no cysts in any other location. Serological tests were negative for cystic echinococcosis. The patient was operated on and the cyst was completely excised. The pathologic examination confirmed the diagnosis of hydatid cyst.

Lissencephaly--not an uncommon cause of intractable seizure in children: report of 3 cases.

Lissencephaly or azyria, a rare disorder characterised by the absence of cerebral convolutions and poorly formed sylvlan fissures giving the appearance of a foetal brain with smooth cerebral surface, thickened cortical mantle and microscopic appearance ofincomplete neuronal migration. It is to consider lissencephaly in the diagnosis of developmental delay with seizure disorder as many patients may be diagnosed as cerebral palsy. Several lissencephaly syndrome have been described, Here three cases of lissencephaly with developmental delay and Intractable seizures are reported.

Oropharyngeal true teratoma.

Oropharyngeal teratoma in newborn is very rare. Here we report a case of oropharyngeal true teratoma where a 17-day-old female baby presented with a protruding mass from oropharynx with episodic respiratory distress and feeding difficulty complicated by aspiration pneumonia, and treated successfully with coordinated team approach.

Menkes kinky hair disease: A case report.

An eight month old male infant with protein energy malnutrition was admitted in the hospital with the history of repeated attacks of convulsion since four months of age. He was also suffering from frequent attacks of cough and cold since 6 months of age which was marked prior to admission. The infant had fair complexion, sparse fuzzy wooly hair with marked trunkal hypotonia. He had also mental retardation. Serum copper and ceruloplasmin levels were low, MRI showed prominent extraaxial spaces with gliosis, MR angiography revealed tortuosity of cerebral vessels. Microscopic examination of hair revealed pili torti. The patient was diagnosed as Menkes disease and treated symptomatically. For lack of facilities we were not able to do genetic study.

Extragonadal teratomas presenting at birth and originating from 3 different sites--a report of 3 cases.

Three cases of extragonadal teratomas presented at birth and all the cases arisen from three separate sites are reported in the present study. A huge sacrococcygeal teratoma is being reported and the other two retroperitoneal and nasopharyngeal teratomas, are reported for the rarity of their location in neonatal period. Teratomas of all three babies were mature benign on histopathology and surgical removal sufficed as mode of treatment. No recurrence was noted on follow-up.