Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0-2-month old low-birth weight infants in India: the ProSPoNS trial

Sinha, A. et al. (2023) Study protocol for economic evaluation of probiotic intervention for prevention of neonatal sepsis in 0-2-month old low-birth weight infants in India: the ProSPoNS trial. BMJ Open, 13(3), e068215. (doi: 10.1136/bmjopen-2022-068215) (PMID:36990484) (PMCID:PMC10069556)

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Abstract

Introduction: The ProSPoNS trial is a multicentre, double-blind, placebo-controlled trial to evaluate the role of probiotics in prevention of neonatal sepsis. The present protocol describes the data and methodology for the cost utility of the probiotic intervention alongside the controlled trial. Methods and analysis: A societal perspective will be adopted in the economic evaluation. Direct medical and non-medical costs associated with neonatal sepsis and its treatment would be ascertained in both the intervention and the control arm. Intervention costs will be facilitated through primary data collection and programme budgetary records. Treatment cost for neonatal sepsis and associated conditions will be accessed from Indian national costing database estimating healthcare system costs. A cost–utility design will be employed with outcome as incremental cost per disability-adjusted life year averted. Considering a time-horizon of 6 months, trial estimates will be extrapolated to model the cost and consequences among high-risk neonatal population in India. A discount rate of 3% will be used. Impact of uncertainties present in analysis will be addressed through both deterministic and probabilistic sensitivity analysis. Ethics and dissemination: Has been obtained from EC of the six participating sites (MGIMS Wardha, KEM Pune, JIPMER Puducherry, AIPH, Bhubaneswar, LHMC New Delhi, SMC Meerut) as well as from the ERC of LSTM, UK. A peer-reviewed article will be published after completion of the study. Findings will be disseminated to the community of the study sites, with academic bodies and policymakers. Registration: The protocol has been approved by the regulatory authority (Central Drugs Standards Control Organisation; CDSCO) in India (CT-NOC No. CT/NOC/17/2019 dated 1 March 2019). The ProSPoNS trial is registered at the Clinical Trial Registry of India (CTRI). Registered on 16 May 2019. Trial registration number: CTRI/2019/05/019197; Clinical Trial Registry.

Item Type:Articles
Additional Information:The study is funded by the Department of Health and Social Care (DHSC), the Foreign, Commonwealth & Development Office (FCDO), the Medical Research Council (MRC) and Wellcome. Award/grant number is MR/S004912/1.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Bahuguna, Dr Pankaj
Authors: Sinha, A., Bahuguna, P., Gupta, S. S., Kuruba, Y. P., Poluru, R., Mathur, A., Raja, D., Raut, A. V., Mahajan, K. S., Sudhakar, R., Kulkarni, B., Pandey, R. M., Arora, N. K., and Prinja, S.
College/School:College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:29 March 2023
Copyright Holders:Copyright © 2023 The Authors
First Published:First published in BMJ Open 13(3): e068215
Publisher Policy:Reproduced under a Creative Commons License

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