The ProSPoNS Trial: Statistical Analysis Protocol for Evaluating Efficacy of Probiotic Supplementation for Prevention of Neonatal Sepsis in 0–2-month-old Low Birth Weight Infants in India

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Abstract Introduction: A Phase III multicentre randomised, double-blind, placebo-controlled trial evaluating the role of probiotics in the prevention of neonatal sepsis in 0–2-month-old Indian infants was conducted at six study sites in India, funded by UKRI-MRC and coordinated by ICMR. Methods and Analysis: The primary objective is to reduce the incidence of sepsis by 30%. This statistical analysis plan (SAP) identifies the procedures to be applied to the primary and secondary analyses for the ProSPoNS trial once the trial data are completed. The SAP was finalised during trial implementation, and all analyses were prospectively defined. This article briefly describes the study design and statistical methods used to analyse the primary and secondary outcomes. The SAP also outlines the planned sensitivity and subgroup analyses that will be performed to explore the robustness and generalisability of the results. The document describes methods for handling missing data, controlling for confounding variables and using statistical tests to compare the treatment groups. It also describes sensitivity or subgroup analyses that will be performed.

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