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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).)

Background: Sensory processing refers to receiving, organizing, and interpreting sensory stimuli from the sensory system. Unlike other neurodevelopmental disorders, knowledge about the sensory processing abilities of children with cerebral palsy (CP) is lacking., Objective: To study the difference in sensory processing abilities of children with cerebral palsy in comparison to age matched typically developing children (TDC)., Methods and Material: A cross-sectional analysis of sensory processing abilities of children with CP and TDC was performed from July 2018 through February 2020. The child sensory profile2 (CSP2) caregiver questionnaire was used to detect sensory processing differences (SPD) across nine sensory domains and four sensory processing patterns. A comparison was made between the two study groups as well as between the CP subtypes., Result: Around 226 children with CP and 58 TDC were screened. Finally, 150 children with CP and 50 TDC were enrolled. Probable SPD (>1SD) was observed in (121/150) 80.7% of children with CP compared to (13/50) 26% in TDC (p < 0.001). Definite SPD (>2SD) was seen in 40.7% (61/150) of children with CP vs. none in TDC (p < 0.001). The body position domain which tests the vestibular and proprioceptive processing was primarily affected in CP. Most children with CP fell under the "bystander" pattern suggesting poor registration of sensory stimuli. No significant difference in the pattern of sensory processing was observed between the CP subtypes. Prevalence of definite SPD positively correlated with the gross motor functional classification system level., Conclusion: Sensory processing abilities of children with CP differ significantly from TDC. Proprioceptive and vestibular sensory processing is primarily affected in CP., (Copyright © 2024 Copyright: © 2024 Neurology India, Neurological Society of India.)