Prevention of Infection in Indian Neonates - Phase II Probiotics Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 284
- 试验地点
- 3
- 主要终点
- Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
研究概览
简要总结
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
详细描述
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a day for the first 7 days of life. The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants ≥ 35 weeks and ≥1800g born in the hospital
- •Infants > 12 hours and < 72 hours of age at enrollment
- •Infants likely to be hospitalized for 5-7 days without antibiotic treatment
- •Informed consent by one parent or guardian
- •Infants begun breastfeeding
排除标准
- •Antibiotic therapy prior to enrollment
- •Evidence or suspicion of clinical sepsis before randomization
- •Inability (as determined by the physician) to tolerate oral feeding of study supplement
- •Presence of major congenital anomalies
- •Infant's home is >30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
结局指标
主要结局
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
时间窗: 28 days
Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.
时间窗: 28 days
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
次要结局
- Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early).