Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.
Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0-2-month-old low birth weight infants in India-the "ProSPoNS" Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial.
复制标题
DOI：
10.1186/s13063-021-05193-w
复制
发表时间：
2021-04-01
期刊：
影响因子：
2.5
通讯作者：
ProSPoNS study Group
中科院分区：
文献类型：
--
作者：
Sinha AP;Gupta SS;Poluru R;Raut AV;Arora NK;Pandey RM;Sahu AR;Bethou A;Sazawal S;Parida S;Bavdekar A;Saili A;Gaind R;Kapil A;Garg BS;Maliye C;Jain M;Mahajan KS;Dhingra P;Pradhan KC;Kawade AS;Nangia S;Mukherjee A;Rasaily R;Sharma RS;ProSPoNS study Group
印度在降低五岁以下儿童死亡率方面取得了进展；然而，新生儿死亡率下降的速度较慢。需要努力降低新生儿死亡率，以实现可持续发展目标3。在高危、易受感染的低出生体重儿中，用益生菌补充剂进行新的干预措施预防败血症是有希望的。一项第三阶段的多中心、随机、双盲、安慰剂对照研究正在印度的六个地点进行。在获得婴儿父母的书面知情同意后，共有6144名符合资格标准的健康低出生体重(LBW)婴儿将在出生后第一周内登记。按地点、性别和出生体重分层的1：1随机化将通过使用标准网络浏览器和电子邮件服务的交互式网络响应系统(IWRS)进行。一种含有8种细菌混合的益生菌Vivomixx®，以标准的悬浮液形式提供100亿cfu/ml，或有机感官上类似的安慰剂，按1毫升/天的剂量喂给登记的婴儿，持续30 天。对登记的婴儿进行为期60 天的跟踪，将按照预先指定的时间表进行，以记录六个参与地点的发病率和结果评估。疾病筛查将由社区中训练有素的现场工作人员进行，患病婴儿将被转介到指定的诊所/医院。医生会检查有主诉和临床症状的转介婴儿，并从患病婴儿身上采集血液样本，通过败血症筛查和血液培养诊断为新生儿败血症。将根据医院协议提供适当的治疗。这项研究将按照MRC关于全球健康试验管理的指南实施，符合ICH-GCP和印度监管指南。将聘请一个合同研究组织进行全面监测和质量保证。最终分析将按照统计分析计划(SAP)以盲法进行，以评估脓毒症、可能的严重细菌感染(PSBI)和次要结果。在DMC许可后，密码将被破解。利物浦热带医学院研究伦理委员会(REC-LSTM)已经从六个学科招募参与地点的研究伦理委员会审查了该方案。这项动力充足且设计良好的试验将最终回答益生菌是否可以预防低出生体重婴儿高危人群中的新生儿败血症的问题，这一问题由对1340名LBW婴儿的初步研究、来自医院研究的系统评价的证据以及对奥里萨邦健康新生儿的初步研究表明。这项研究的结果将适用于印度和其他中低收入国家。印度临床试验注册(CTRI)CTRI/2019/05/019197。在2019年5月16日登记
Progress has been made in the reduction of under-five mortality in India; however, neonatal mortality is reducing at a slower rate. Efforts are required to bring down neonatal mortality in order to attain the Sustainable Development Goal-3. Prevention of sepsis among the high-risk, vulnerable low birth weight neonates by a newer intervention with probiotic supplementation is promising. A phase III, multicenter, randomized, double-blind, placebo-controlled study is being conducted at six sites in India. A total of 6144 healthy low birth weight (LBW) infants fulfilling the eligibility criteria would be enrolled within the first week of life, after obtaining written informed consent from the parents of the infant. Randomization in 1:1 ratio, stratified by site, sex, and birth weight, would be done through an interactive web response system (IWRS) using a standard web browser and email service. Vivomixx®, a probiotic containing a mix of 8 strains of bacteria, in a suspension form standardized to deliver 10 billion CFU/ml, or an organoleptically similar placebo would be fed to enrolled infants in a 1-ml/day dose for 30 days. The follow-up of enrolled infants for 60 days would take place as per a pre-specified schedule for recording morbidities and outcome assessments at the six participating sites. Screening for morbidities would be conducted by trained field workers in the community, and sick infants would be referred to designated clinics/hospitals. A physician would examine the referred infants presenting with complaints and clinical signs, and blood samples would be collected from sick infants for diagnosis of neonatal sepsis by performing sepsis screen and blood culture. Appropriate treatment would be provided as per hospital protocol. The study would be implemented as per the MRC guideline for the management of Global Health Trials in accordance with ICH-GCP and Indian Regulatory guidelines. A contract research organization would be engaged for comprehensive monitoring and quality assurance. The final analysis would be conducted in a blinded manner as per the statistical analysis plan (SAP) to estimate the primary outcomes of sepsis, possible serious bacterial infection (PSBI), and secondary outcomes. The codes will be broken after DMC permission. The protocol has been reviewed by the Research Ethics Committee of the Liverpool School of Tropical Medicine (REC-LSTM), from Research Ethics Committees of the six subject recruitment participating sites. This adequately powered and well-designed trial would conclusively answer the question whether probiotics can prevent neonatal sepsis in the high-risk group of low birth weight infants as indicated by a pilot study in 1340 LBW infants, evidence from systematic reviews of hospital-based studies, and a primary study on healthy newborns in Orissa. Results of the study would be generalizable to India and other low–middle-income countries. Clinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019
登录
查看更多内容
DOI：
10.4049/jimmunol.1403169
发表时间：
2015-05-01
期刊：
Journal of immunology (Baltimore, Md. : 1950)
影响因子：
--
作者：
Sassone-Corsi M;Raffatellu M
通讯作者：
Raffatellu M
DOI：
10.1136/fetalneonatal-2011-301373
发表时间：
2012-11
期刊：
Archives of disease in childhood. Fetal and neonatal edition
影响因子：
--
作者：
Madan JC;Salari RC;Saxena D;Davidson L;O'Toole GA;Moore JH;Sogin ML;Foster JA;Edwards WH;Palumbo P;Hibberd PL
通讯作者：
Hibberd PL
影响因子：
64.8
作者：
Panigrahi, Pinaki;Parida, Sailajanandan;Gewolb, Ira H.
通讯作者：
Gewolb, Ira H.
影响因子：
5.9
作者：
Baldassarre, Maria Elisabetta;Di Mauro, Antonio;Laforgia, Nicola
通讯作者：
Laforgia, Nicola
影响因子：
3.7
作者：
Patole SK;Rao SC;Keil AD;Nathan EA;Doherty DA;Simmer KN
通讯作者：
Simmer KN