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other·pediatrics, clinical trial, epidemiology, public health, research methods·PMC10069556

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 · 14 authors, 7 centres

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TL;DR

This is a study protocol describing a cost-utility analysis planned alongside a multicentre double-blind placebo-controlled RCT of probiotics to prevent neonatal sepsis in low-birth-weight Indian neonates. No trial results are reported; the protocol outlines planned methods for estimating incremental cost per disability-adjusted life year averted from a societal perspective.

Full summary

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This protocol describes a planned cost-utility analysis (CUA) conducted alongside the ProSPoNS multicentre double-blind placebo-controlled RCT. The primary economic outcome is incremental cost per disability-adjusted life year (DALY) averted, adopting a societal perspective that captures direct medical and non-medical costs. A 6-month time horizon with 3% discounting is planned, and trial data will be extrapolated via decision-analytic modelling to the broader high-risk neonatal population in India. Sensitivity analyses (deterministic and probabilistic) are planned to address uncertainty. As a protocol paper, no empirical results are available.

STUDY TYPE

other

SPECIALTY

pediatrics

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AI pipeline

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100% · A

ORIGINAL PAPER

PMC10069556

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

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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.

CITATION EXPORT

Anju Sinha, Pankaj Bahuguna, Subodh Sharan Gupta et al.. 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. (2023). https://doi.org/10.1136/bmjopen-2022-068215

AUTHORS

14 · 7 CENTRES

Anju Sinha, Pankaj Bahuguna, Subodh Sharan Gupta, Yamini Priyanka Kuruba, Ramesh Poluru, Apoorva Mathur, Dilip Raja, Abhishek V Raut, Kamaleshwar S Mahajan, Rishikesh Sudhakar, Bharati Kulkarni, Ravindra Mohan Pandey, Narendra K. Arora, Shankar Prinja

1Reproductive, Child Health and Nutrition, Indian Council of Medical Research, New Delhi, Delhi, India
2Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research School of Public Health, Chandigarh, India
3School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, Scotland's Western Lowlands, UK
4Community Medicine, MGIMS, Wardha, India
5Research Department, The INCLEN Trust International, New Delhi, India
6Department of Community Medicine, Mahatma Gandhi Institute of Medical Sciences, Sevagram, India
7Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India