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Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.

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العنوان: Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.
المؤلفون: Sinha AP; Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India. apradhandr@gmail.com., Gupta SS; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Poluru R; The International Clinical Epidemiology Network (INCLEN) Trust International, F-1/5, 2nd Floor, Okhla Industrial Area Phase - 1, New Delhi, Delhi, 110019, India., Raut AV; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Arora NK; The International Clinical Epidemiology Network (INCLEN) Trust International, F-1/5, 2nd Floor, Okhla Industrial Area Phase - 1, New Delhi, Delhi, 110019, India., Pandey RM; Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India., Sahu AR; Next Gen Pharma India Pvt. Ltd., 331, Sector 15A, Noida, Uttar Pradesh, 201301, India., Bethou A; Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantri Nagar, Gorimedu, Puducherry, 605006, India., Sazawal S; Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India., Parida S; Neonatal Health & Human Nutrition, Asian Institute of Public Health (AIPH), 8A, Unit-6, Ganga Nagar (Near Raj Bhawan), Bhubaneswar, Odisha, 751001, India., Bavdekar A; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India., Saili A; Department of Neonatology, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital (KSCH), Near Gole Market, Central Dist., New Delhi, Delhi, 110001, India., Gaind R; Department of Microbiology, Vardhaman Mahavir Medical College and Safdarjung Hospital (VMMC & SJH), Ansari Nagar (W), New Delhi, Delhi, 110029, India., Kapil A; Department of Microbiology, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India., Garg BS; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Maliye C; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Jain M; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Mahajan KS; Department of Community Medicine, Dr. Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sewagram, Wardha, Maharashtra, 442102, India., Dhingra P; Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India., Pradhan KC; Neonatal Health & Human Nutrition, Asian Institute of Public Health (AIPH), 8A, Unit-6, Ganga Nagar (Near Raj Bhawan), Bhubaneswar, Odisha, 751001, India., Kawade AS; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India., Nangia S; Department of Neonatology, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital (KSCH), Near Gole Market, Central Dist., New Delhi, Delhi, 110001, India., Mukherjee A; Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India., Rasaily R; Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India., Sharma RS; Division of Reproductive Biology, Maternal & Child Health (RBM&CH), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.
مؤلفون مشاركون: ProSPoNS study Group
المصدر: Trials [Trials] 2021 Apr 01; Vol. 22 (1), pp. 242. Date of Electronic Publication: 2021 Apr 01.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Neonatal Sepsis* , Probiotics*/adverse effects, Double-Blind Method ; Humans ; India ; Infant ; Infant, Low Birth Weight ; Infant, Newborn ; Multicenter Studies as Topic ; Pilot Projects ; Randomized Controlled Trials as Topic
مستخلص: Background: Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising.
Methods: A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites.
Discussion: This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low-middle-income countries.
Trial Registration: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197 . Registered on 16 May 2019.
References: J Perinatol. 2005 Mar;25 Suppl 1:S72-81. (PMID: 15791281)
Nature. 2017 Aug 24;548(7668):407-412. (PMID: 28813414)
N Engl J Med. 2011 Jan 20;364(3):255-64. (PMID: 21247316)
Emerg Infect Dis. 2016 Sep;22(9):1664-6. (PMID: 27532215)
Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F257-63. (PMID: 25425653)
Lancet. 2020 May 23;395(10237):1640-1658. (PMID: 32413293)
J Perinatol. 2016 Dec;36(12):1106-1111. (PMID: 27583387)
Clin Infect Dis. 2003 Mar 15;36(6):775-80. (PMID: 12627362)
BMJ Open. 2017 Dec 7;7(12):e017638. (PMID: 29222137)
Pediatrics. 2008 Oct;122(4):693-700. (PMID: 18829790)
Pediatrics. 2016 Mar;137(3):e20153684. (PMID: 26908700)
Pediatrics. 2005 Jan;115(1):178-81. (PMID: 15629999)
Cochrane Database Syst Rev. 2014 Apr 10;(4):CD005496. (PMID: 24723255)
BMJ Open. 2015 Jul 10;5(7):e006564. (PMID: 26163028)
Nutrients. 2017 Aug 22;9(8):. (PMID: 28829405)
Early Hum Dev. 2012 May;88 Suppl 2:S69-74. (PMID: 22633519)
Medicine (Baltimore). 2016 Feb;95(8):e2581. (PMID: 26937897)
Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F456-62. (PMID: 22562869)
Clin Microbiol Infect. 1999 May;5(5):290-292. (PMID: 11856270)
J Pediatr Surg. 2015 Aug;50(8):1405-12. (PMID: 26216544)
J Immunol. 2015 May 1;194(9):4081-7. (PMID: 25888704)
Am J Physiol Gastrointest Liver Physiol. 2017 Jan 1;312(1):G34-G45. (PMID: 27856417)
Lancet. 2012 Jun 9;379(9832):2206-11. (PMID: 22682467)
PLoS One. 2016 Mar 08;11(3):e0150775. (PMID: 26953798)
Curr Nutr Food Sci. 2013 May 1;9(2):99-107. (PMID: 24353483)
Nutrients. 2018 Feb 10;10(2):. (PMID: 29439395)
Clin Infect Dis. 2015 Mar 15;60(6):924-7. (PMID: 25472946)
Clin Dev Immunol. 2013;2013:270301. (PMID: 23737810)
J Perinatol. 2014 Feb;34(2):125-9. (PMID: 24355942)
J Clin Gastroenterol. 2008 Sep;42 Suppl 3 Pt 1:S126-9. (PMID: 18806703)
Science. 2005 Jun 10;308(5728):1635-8. (PMID: 15831718)
معلومات مُعتمدة: United Kingdom WT_ Wellcome Trust; MR/S004912/1 United Kingdom MRC_ Medical Research Council
فهرسة مساهمة: Investigator: P Gupta; A Kumar; S Sarma; A Mathur; D Prajapati; K Yadav; NK Kashyap
Keywords: India; Low birth weight; Neonatal sepsis; Probiotics; Randomized controlled trial; Study protocol; Vivomixx®
تواريخ الأحداث: Date Created: 20210402 Date Completed: 20210617 Latest Revision: 20210617
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC8017823
DOI: 10.1186/s13063-021-05193-w
PMID: 33794969
قاعدة البيانات: MEDLINE
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