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
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.Meth...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-03-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e068215.full |
| _version_ | 1797856466854477824 |
|---|---|
| author | Ravindra Mohan Pandey Shankar Prinja Anju Sinha Pankaj Bahuguna Bharati Kulkarni Subodh Sharan Gupta Yamini Priyanka Kuruba Ramesh Poluru Apoorva Mathur Dilip Raja Abhishek V Raut Kamaleshwar S Mahajan Rishikesh Sudhakar Narendra K. Arora |
| author_facet | Ravindra Mohan Pandey Shankar Prinja Anju Sinha Pankaj Bahuguna Bharati Kulkarni Subodh Sharan Gupta Yamini Priyanka Kuruba Ramesh Poluru Apoorva Mathur Dilip Raja Abhishek V Raut Kamaleshwar S Mahajan Rishikesh Sudhakar Narendra K. Arora |
| author_sort | Ravindra Mohan Pandey |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T20:40:55Z |
| format | Article |
| id | doaj.art-259c0f2646c043de8c3341ce81cc9af8 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T20:40:55Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-259c0f2646c043de8c3341ce81cc9af82023-03-30T02:30:06ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-068215Study 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 trialRavindra Mohan Pandey0Shankar Prinja1Anju Sinha2Pankaj Bahuguna3Bharati Kulkarni4Subodh Sharan Gupta5Yamini Priyanka Kuruba6Ramesh Poluru7Apoorva Mathur8Dilip Raja9Abhishek V Raut10Kamaleshwar S Mahajan11Rishikesh Sudhakar12Narendra K. Arora13All India Institute of Medical Sciences (AIIMS), New Delhi, India1 Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh, IndiaIndian Council of Medical Research (ICMR), New Delhi, IndiaDepartment of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research School of Public Health, Chandigarh, IndiaClinical Division, ICMR-National Institute of Nutrition, Hyderabad, Telangana, IndiaCommunity Medicine, MGIMS, Wardha, IndiaReproductive, Child Health and Nutrition, Indian Council of Medical Research, New Delhi, Delhi, IndiaResearch Department, The INCLEN Trust International, New Delhi, IndiaReproductive, Child Health and Nutrition, Indian Council of Medical Research, New Delhi, Delhi, IndiaReproductive, Child Health and Nutrition, Indian Council of Medical Research, New Delhi, Delhi, IndiaDepartment of Community Medicine, Mahatma Gandhi Institute of Medical Sciences, Sevagram, IndiaDepartment of Community Medicine, Mahatma Gandhi Institute of Medical Sciences, Sevagram, IndiaResearch Department, The INCLEN Trust International, New Delhi, IndiaResearch Department, The INCLEN Trust International, New Delhi, IndiaIntroduction 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.https://bmjopen.bmj.com/content/13/3/e068215.full |
| spellingShingle | Ravindra Mohan Pandey Shankar Prinja Anju Sinha Pankaj Bahuguna Bharati Kulkarni Subodh Sharan Gupta Yamini Priyanka Kuruba Ramesh Poluru Apoorva Mathur Dilip Raja Abhishek V Raut Kamaleshwar S Mahajan Rishikesh Sudhakar Narendra K. Arora 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/13/3/e068215.full |
| work_keys_str_mv | AT ravindramohanpandey studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT shankarprinja studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT anjusinha studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT pankajbahuguna studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT bharatikulkarni studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT subodhsharangupta studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT yaminipriyankakuruba studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT rameshpoluru studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT apoorvamathur studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT dilipraja studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT abhishekvraut studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT kamaleshwarsmahajan studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT rishikeshsudhakar studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial AT narendrakarora studyprotocolforeconomicevaluationofprobioticinterventionforpreventionofneonatalsepsisin02montholdlowbirthweightinfantsinindiatheprosponstrial |