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Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.

التفاصيل البيبلوغرافية
العنوان: Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.
المؤلفون: Sinha AP; Division of Reproductive, Child Health and Nutrition (RCN), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India. apradhandr@gmail.com., Raja D; Division of Reproductive, Child Health and Nutrition (RCN), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, 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., Sharma P; Division of Reproductive, Child Health and Nutrition (RCN), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India., 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., Kawade AS; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India., Dayma G; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India., Sazawal S; Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India., Bavdekar A; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, 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., 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., 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., Bethou A; Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantri Nagar, Gorimedu, Puducherry, 605006, India., Devi P; Centre for Public Health Kinetics (CPHK), 214 A, Vinoba Puri, Lajpat Nagar-II, New Delhi, Delhi, 110024, India., Gorpade M; Department of Pediatrics, KEM Hospital Research Centre, 489 Rasta Peth, Sardar Moodliar Road, Pune, Maharashtra, 411011, India., Fatima T; Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantri Nagar, Gorimedu, Puducherry, 605006, India., Nayak R; Neonatal Health & Human Nutrition, Asian Institute of Public Health (AIPH), 8A, Unit-6, Ganga Nagar (Near Raj Bhawan), Bhubaneswar, Odisha, 751001, India., Kapil A; Department of Microbiology, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, India., Azam M; 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., Khan PA; Division of Reproductive, Child Health and Nutrition (RCN), Indian Council of Medical Research (ICMR) Headquarters, V Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India., Pandey RM; Department of Biostatistics, All India Institute of Medical Sciences (AIIMS), New Delhi, Delhi, 110029, 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.
مؤلفون مشاركون: ProSPoNS Study Group
المصدر: Trials [Trials] 2024 Jul 05; Vol. 25 (1), pp. 458. Date of Electronic Publication: 2024 Jul 05.
نوع المنشور: 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*/diagnosis , Neonatal Sepsis*/drug therapy, Humans ; Infant, Newborn ; Endpoint Determination/standards ; India ; Infant Mortality ; Probiotics/therapeutic use ; Probiotics/adverse effects ; Randomized Controlled Trials as Topic ; Research Design ; Sample Size ; Treatment Outcome ; Clinical Trial Protocols as Topic
مستخلص: Despite progress in reducing the infant mortality in India, the neonatal mortality decline has been slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming to prevent neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention includes probiotic supplementation. This article communicates the decision by the ProSPoNS trial investigators to establish a Central Endpoint Adjudication Committee (CEAC) as an addendum to the protocol published in Trials in 2021 for the purpose of clarifying the primary outcome. In the published protocol, the study hypothesis and primary objective are based on "sepsis," the primary outcome has been specified as sepsis/PSBI, whereas the sample size estimation was performed based on the "physician diagnosed sepsis." To align all the three above, the investigators meeting, held on 17th-18th August 2023, at MGIMS Sevagram, Wardha, deliberated and unanimously agreed that "physician diagnosed sepsis" is the primary study outcome which includes sepsis/PSBI. The CEAC, chaired by an external subject expert and members including trial statistician, a microbiologist, and all site principal investigators will employ four criteria to determine "physician diagnosed sepsis": (1) blood culture status, (2) sepsis screen status, (3) PSBI/non-PSBI signs and symptoms, and (4) the clinical course for each sickness event. Importantly, this clarification maintains consistency with the approved study protocol (Protocol No. 5/7/915/2012 version 3.1 dated 14 Feb 2020), emphasizing the commitment to methodological transparency and adherence to predefined standards. The decision to utilize the guidance of a CEAC is recommended as the gold standard in multicentric complex clinical trials to achieve consistency and accuracy in assessment of outcomes.Trial registrationClinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.
(© 2024. The Author(s).)
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معلومات مُعتمدة: United Kingdom WT_ Wellcome Trust; ICMR-FCRA/2019-2020/Project-08 Indian Council of Medical Research
فهرسة مساهمة: Investigator: D Prajapati; A Mathur; P Gupta; P Kumari
Keywords: Adjudication; Clinical trial; Neonatal; ProSPoNS; Sepsis
تواريخ الأحداث: Date Created: 20240705 Date Completed: 20240705 Latest Revision: 20240829
رمز التحديث: 20240830
مُعرف محوري في PubMed: PMC11227181
DOI: 10.1186/s13063-024-08298-0
PMID: 38970042
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-024-08298-0