Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial.

OBJECTIVE: To examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE). DESIGN: Double-blind pilot randomised controlled trial. SETTING: Eight neonatal units in South Asia. PATIENTS: Neonates (≥36 weeks) with moderate or severe HIE admitted between 31 December 2022 and 3 May 2023. INTERVENTIONS: Erythropoietin (500 U/kg daily) or to the placebo (sham injections using a screen) within 6 hours of birth and continued for 9 days. MRI at 2 weeks of age. MAIN OUTCOMES AND MEASURES: Feasibility of randomisation, drug administration and assessment of brain injury using MRI. RESULTS: Of the 154 neonates screened, 56 were eligible; 6 declined consent and 50 were recruited; 43 (86%) were inborn. Mean (SD) age at first dose was 4.4 (1.2) hours in erythropoietin and 4.1 (1.0) hours in placebo. Overall mortality at hospital discharge occurred in 5 (19%) vs 11 (46%) (p=0.06), and 3 (13%) vs 9 (40.9%) (p=0.04) among those with moderate encephalopathy in the erythropoietin and placebo groups. Moderate or severe injury to basal ganglia, white matter and cortex occurred in 5 (25%) vs 5 (38.5%); 14 (70%) vs 11 (85%); and 6 (30%) vs 2 (15.4%) in the erythropoietin and placebo group, respectively. Sinus venous thrombosis was seen in two (10%) neonates in the erythropoietin group and none in the control group. CONCLUSIONS: Brain injury and mortality after moderate or severe HIE are high in South Asia. Evaluation of erythropoietin monotherapy using MRI to examine treatment effects is feasible in these settings. TRIAL REGISTRATION NUMBER: NCT05395195.

"Caring for the Uncared for": A Novel Initiative of Madras Medical College.

BACKGROUND: Every society has persons with illness who do not have any family support. Taking care of such uncared-for patients requires a well-structured system providing medical, psychological, emotional, and rehabilitory support. The first ever rehabilitation ward among government hospitals in Tamil Nadu was created at Rajiv Gandhi Government General Hospital (RGGGH), Chennai with the motto of "Caring for the uncared for." This paper highlights the organizational structure, functionality, profile of patients admitted, challenges faced, and the outcome of patients admitted in the rehabilitation ward. METHODS: A retrospective study was done on the "untended" patients, who were admitted in the rehabilitation ward at Rajiv Gandhi Government General Hospital (RGGGH), Chennai, Tamil Nadu, India from December 2020 to June 2022. Sociodemographic and clinical characteristics and outcome of the patients were analyzed. RESULTS: A total of 201 adults with physical disabilities or mixed physical and psychiatric disabilities were admitted for intensive rehabilitation. Common medical illnesses included orthopedic disorders in 80 (39.8%), followed by neurological illness in 43 (21.4%) patients. The median length of stay was 50 (24.5-103.5) days with longest stay of 447 days. Of those patients who recovered, 54 patients (26.9%) reunited with family and returned home and 125 (62.2%) patients were sent to old age homes/asylums. CONCLUSION: A dedicated ward for untended patients is the first of its kind in the state of Tamil Nadu, India. Such a venture has proved to be of benefit, considering the positive outcome in a significant proportion of the beneficiaries.

Clinico-Epidemiological Profile of COVID-19 Patients with Omicron Variant Admitted in a Tertiary Care Center, South India.

Background and Objectives: Omicron, a variant of SARS COV2, is looming large as a cause of global concern. Its high transmissibility can pose challenges in healthcare allocation in a highly populous country like India. Studying the behaviour of the virus among the Indian population will definitely help in planning for the impending omicron surge, so we conducted a preliminary analysis of the clinical and epidemiological characteristics of the suspected omicron cases in the early part of the surge. Methodology: The study was conducted in the Rajiv Gandhi Government General Hospital, from 17th December 2021 to 11th January 2022. A total number of 159 consecutive patients ≥18 years of age with the S gene target failure were enrolled and clinically followed up during hospitalisation. Results: Nearly half (n = 79, 49.7%) were aged between 18 and 30 years and the mean (SD) age of the patients was 35.1 (14.9); 52.8% (n = 84) were males and 54.7% (n = 87) were healthcare workers. The NLR ratio and CRP were raised in unvaccinated individuals. Out of 159 patients, only 4 patients required oxygen and all the others showed a mild course of illness and there was no mortality. Conclusion: The clinical course of suspected omicron patients was mild in those who were vaccinated. Unvaccinated individuals with comorbid illness need to be closely monitored for prompt referral for acute care. Further studies are needed in the high-risk group with omicron.

Efficient control of IL-6, CRP and Ferritin in Covid-19 patients with two variants of Beta-1,3-1,6 glucans in combination, within 15 days in an open-label prospective clinical trial

ObjectiveIn this study, we evaluated the efficiency of the combination of two variants AFO-202 and N-163 strains of Aureobasidium Pullulans produced in comparison with the control arm, which underwent a conventional regimen of treatment alone, for a shorter duration of 15 days. MethodsA total of 40 RT-PCR positive Covid-19 patients divided into two groups (Gr): Gr. 1 control (n=22) - Standard treatment; Gr. 2 (n =18) - Standard treatment + combination of AFO-202 and N-163 beta glucans for 15 days. Biomarkers of relevance to cytokine storm and coagulopathy were evaluated at baseline on Day 7 and Day 15. ResultsThe C-reactive protein (CRP), which declined from 33.95 mg/l to 5.07 mg/l in control and from 33.95 mg/l to 5.64 mg/l in the treatment arm on Day 7, increased to 14.6 mg/l in the former while it continued to be under control in the treatment arm at 5.68 mg/l on Day 15. The same trend was observed in Ferritin, whose values were 560.58 ng/ml at baseline to 261.44 ng/ml (day-7) and 182.40 ng/ml (day-15) in the treatment group, while it was 535.24 ng/ml at baseline, 116.66 ng/ml on day 7 and 291.95 ng/ml on day 15 in the control group. IL-6 showed a higher decrease in treatment group compared to the control group. The difference between day 7 and day 15 values were statically significant. ConclusionA statistically significant control of IL-6, CRP and Ferritin in Covid-19 patients who orally consumed AFO-202 and N-163 strains of Aureobasidium Pullulans produced Beta glucans together in 15 days make us recommend this safe food supplement be consumed by Covid-19 patients along with conventional treatments, especially to the vulnerable population, as a prophylaxis amidst the prolonged pandemic with evolution of mutated strains of SARS-COV2.