Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy of Probiotic Supplementation for Prevention of Neona

摘要（外行）：新生儿感染是发展中国家婴儿期疾病和死亡的主要原因。抗生素治疗具有局限性，因为细菌已经产生耐药性，并且缺乏新的抗生素。目前，人们对如何预防这种疾病缺乏了解。目前的试验旨在确定在生命的第一个月内每天喂养益生菌30天是否可以预防这些感染。在第一个月保持健康很重要，因为它可以让新生儿成长为健康的成年人。这项研究将由三个研究组织协调，在印度的六个地点进行。6500名体重小于2500克的新生儿将被分配到益生菌组或安慰剂组，而研究参与者或研究人员不知道组分配。他们将被喂食指定的药物，并由训练有素的现场工作人员定期在家中进行长达60天的随访（第一周每天一次，2-4周内每两周一次，第二个月每周一次），以确定他们是否生病。患病婴儿将被转诊/带至研究医生处进行检查、检测和治疗。所有研究相关信息将在平板电脑/手持设备上采集，并发送至中心位置进行分析。研究完成后，将对数据进行分析，以确定与另一组相比，用益生菌喂养婴儿的组中是否有更少的感染/败血症病例。如果结果有利于益生菌，它可以用作预防发展中国家新生儿感染的新方法。这将使数百万目前因感染而死亡的新生儿受益。

Summary (layman): Neonatal infections are a major cause of sickness and death in infancy in the developing countries. Treatment with antibiotics has limitation as the bacteria have become resistant and there is dearth of new antibiotics. At present there is lack of knowledge about how to prevent the disease. Current trial aims to find out if feeding probiotics daily for 30 days during the first month of life would prevent these infections. Remaining healthy in the first month is important as it allows the newborns to grow to become healthy adults. The study would be coordinated by three research organizations and implemented at six sites in India. 6500 Newborn infants weighing less than 2500gms would be allocated to either the probiotics or a placebo group without the study participants' or researchers' knowledge of the group assignment. They would be fed the assigned drug and followed up in their homes regularly upto 60 days by trained field workers (daily in the first week, biweekly during 2-4 weeks of life, and weekly during the second month) to find out if they fell sick. Sick infants would be referred/taken to study physician for examination, testing and treatment. All study related information would be captured on Tablets/hand held devices and sent to a central location for analysis. After completion of the study the data would be analysed to see whether there were less infections/sepsis cases in the group where infants were fed with probiotics as compared to the other group. If the results favour the probiotics it could be used as a new method of preventing neonatal infections in the developing countries. This would benefit millions of newborns who are currently dying due to infections.