Antibiotic regimens for late-onset neonatal sepsis

Korang, Steven Kwasi; Safi, Sanam; Gupta, Munish; Greisen, Gorm; Lausten-Thomsen, Ulrik; Jakobsen, Janus Christian

doi:10.1002/14651858.cd013836

Cited by 2 publications

(2 citation statements)

References 134 publications

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“…In another exercise, we have examined the certainty of evidence from Cochrane systematic reviews on neonatal sepsis (personal communication; presented at the Cochrane colloquium 2023). Eight out of 11 Cochrane reviews reported low to very low certainty of evidence for reasons of indirectness and inconsistency, including inconsistency in how neonatal sepsis was de ned in the studies [14,[28][29][30][31][32].…”

Section: Discussionmentioning

confidence: 99%

“…Some of the reasons for low recruitment rate in the trial observed by us are: disruption of the obstetric services due to COVID-19 priority, lower delivery rate of low birth rate infants, potential participants from out of study catchment area, competing studies at particular site, and lack of engagement are other reasons [13]. Less than optimum recruitment at the site is referred as a 'research waste' in view of time and money spent to build the site [14]. A review of trials funded and published by the UK's Health Technology Assessment program has reported that recruitment patterns in multicenter randomized trials t more closely to Price's Law (50% of participants are recruited by the square root of the total number of sites), than the Pareto Principle (80% of participants are recruited by 20% of sites,) [13].…”

Section: Recruitment Challengementioning

confidence: 93%

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Challenges in Trials on Neonatal Sepsis- Case of ProSPoNS Trial & Role of Central Endpoint Adjudication

Sinha,

Raja,

Mahajan

et al. 2024

Preprint

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Background: Despite progress in reducing Infant mortality in India, neonatal mortality decline is slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming prevention of neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention, including probiotic supplementation. This article communicates the decision by ProSPoNS trial investigators to establish a Central Endpoint Adjudication committee as an addendum to the published protocol in 'Trials 2021.' Methods: In the pursuit of clarity regarding the primary outcome of Sepsis/PSBI in a clinical trial, a crucial decision was reached during the investigators' meeting at MGIMS Sevagram on 17th-18th August 2023. The unanimous consensus was to explicitly define "Physician diagnosed sepsis" as the primary study outcome, encompassing Sepsis/PSBI. This alignment aimed to synchronize the primary objective and outcome with the stated hypothesis, necessitating the establishment of a Central Endpoint Adjudication (CEA) process across all six trial sites. To enact this, the CEA committee, chaired by an external Subject Expert and comprising Site Principal Investigators, a Trial Statistician, and a Microbiologist, will employ four criteria to determine 'Physician diagnosed sepsis' for each sickness event in a study participant. These criteria include Blood culture status, Sepsis screen status, PSBI/non-PSBI signs and symptoms, and the Clinical course during the event, including antibiotic usage. 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. Results: The challenges faced in the trial implementation, such as complex multi-centric design, heterogeneity / extreme variation across sites, inconsistency with definition of sepsis in the neonatal/young infant population, remote vs. on-site training/monitoring during the Covid-19 Pandemic have been described and potential solutions to some of the challenges in clinical trials suggested. Conclusions: The decision to utilize the guidance of a Central Endpoint Adjudication Committee has been suggested as a way forward in the ProSPoNS and other multicentre complex clinical trials. Trial registration: Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.

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