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Antimicrobial Use and Adverse Drug Reaction in Newborns with Neonatal Sepsis: A Prospective Observational Study from a Tertiary Care Teaching Hospital |
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Riddhi C Parmar, Anil P Singh 1. Senior Resident, Department of Pharmacology, P. D. U. Medical College and Civil Hospital, Rajkot, Gujarat, India. 2. Head, Department of Pharmacology, P. D. U. Medical College and Civil Hospital, Rajkot, Gujarat, India. |
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Correspondence Address : Riddhi C Parmar, Department of Pharmacology, P.D.U. gov Medical College and Civil Hospital, Jamnagar Road, Rajkot-360001, Gujarat, India. E-mail: riddhiparmar9060@gmail.com |
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ABSTRACT | |||||||
: Introduction: Neonatal Sepsis (NS) is a major cause of morbidity and mortality worldwide, especially in developing countries like India. The role of antimicrobials is life-saving in NS. To achieve a good prognosis, early diagnosis and appropriate treatment are required. Data related to the irrational use of antimicrobials in neonates are limited. Aim: To evaluate the drug usage pattern and Adverse Drug Reactions (ADRs) of antimicrobials in NS. Materials and Methods: A prospective observational study was conducted among 350 neonates who were admitted and diagnosed with NS from January to December 2021 in the Neonatal Intensive Care Unit (NICU) of PDU Medical College and Civil Hospital, Rajkot, Gujarat, India. Demographic data such as age, sex, birth weight, and clinical data such as type of delivery, type of sepsis, culture-sensitivity status, and antimicrobials used were recorded. Suspected ADRs were reported in the pharmacovigilance database. Categorical data were analysed in percentage, whereas some clinical data were analysed with mean and median using Microsoft Office Excel-2019. Results: In the present study, 172 (49.15%) male and 178 (50.85%) female neonates were almost equally affected. The mean gestational age and birth weight were 35 ± 3.6 weeks and 2 ± 0.7 kg, respectively. Early-Onset Neonatal Sepsis (EONS) cases were more at 273 (78%) compared to Late-Onset Neonatal Sepsis (LONS). Seventeen different antimicrobials were used. The average number of antimicrobials used per case was 2.9. The Piperacillin Tazobactam was the most commonly used antimicrobial in 173 cases (49.43%) in early-onset sepsis, while Meropenem was used in 40 cases (11.43%) in late-onset sepsis. Coagulase-negative Staphylococcus was the most commonly isolated organism in 15 cases (4.2%), followed by Klebsiella Pneumoniae in 13 cases (3.7%). Twelve out of 17 antimicrobials (70.59%) were not included in the first list of essential medicines for children of India in 2011. Six ADRs were reported in the present study. Conclusion: In all admitted cases of sepsis, empirical therapy was given, but variations from standard recommendations were observed in dose and frequency. A periodic survey of antimicrobial use patterns in NS will be useful in the rational selection of empirical therapy. | |||||||
Keywords : Antimicrobial stewardship, Bacterial sensitivity test, Blood culture, Newborn, Staphylococcal infection | |||||||
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DOI and Others :
DOI: 10.7860/IJNMR/2024/69436.2418
Date of Submission: Jan 07, 2024 Date of Peer Review: Feb 06, 2024 Date of Acceptance: Mar 23, 2024 Date of Publishing: Jun 30, 2024 AUTHOR DECLARATION: • Financial or Other Competing Interests: None • Was Ethics Committee Approval obtained for this study? Yes • Was informed consent obtained from the subjects involved in the study? Yes (from parents/guardians) • For any images presented appropriate consent has been obtained from the subjects. NA |
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Original article / research
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