PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Combined infant daily cry/fuss duration
研究概览
简要总结
The aim of the study is to compare prevention (oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks) with treatment-as-needed (supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age). This is a single site pilot study to assess feasibility for a full trial.
详细描述
One in five infants experience colic, defined as recurrent and prolonged episodes of crying and fussing with no obvious cause in healthy infants less than 5 months of age. There is evidence to support the role of the probiotic L. reuteri for treatment of colic in breastfed babies and for prevention of colic. However, these two options (prevention vs treatment-as-needed) have not been previously compared head-to-head. The study aims determine if oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks (prevention) is superior to treatment-as-needed, as measured by daily cry/fuss duration at 6 and 12 weeks of age.
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
- None
盲法说明
For the 2 Randomized arms, all parties were masked. For the 2 Parent Preference arms, all parties were unmasked (open label)
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1 to 7 days of age
- •term (37 to 41 weeks)
- •breast or formula fed
- •birth weight > 2500 grams
- •parental consent
排除标准
- •congenital or other medical disorders
- •parents unable to communicate in English or French
研究组 & 干预措施
Treatment-as-needed (Parent Preference)
Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age
干预措施: L. reuteri (Dietary Supplement)
Prevention (Parent Preference)
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
干预措施: L. reuteri (Dietary Supplement)
Treatment-as-needed (Randomized)
Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age
干预措施: L. reuteri (Dietary Supplement)
Prevention (Randomized)
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
干预措施: L. reuteri (Dietary Supplement)
结局指标
主要结局
Combined infant daily cry/fuss duration
时间窗: 12 weeks
The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.
Combined infant daily cry/fuss duration
时间窗: 6 weeks
The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.
Combined infant daily cry/fuss duration
时间窗: Baseline
The primary outcome will be infant daily cry/fuss duration (combined cry and fuss in minutes) measured using the modified Baby's Day Diary over a 48 hour period.
次要结局
- Infant colic(12 weeks)
- Infant daily fuss duration(6 weeks)
- Gut microbial composition, diversity and function(12 weeks)
- Infant daily cry duration(12 weeks)
- Parent (female and male) fatigue(12 weeks)
- Adverse effects - growth/length(16 weeks)
- Adverse effects - growth/head circumference(16 weeks)
- Health services utilization(12 weeks)
- Infant daily sleep duration(12 weeks)
- Parent (female and male) mental health(12 weeks)
- Adverse effects - digestive upset(16 weeks)
- Adverse effects - growth/weight(16 weeks)
- Infant daily cry duration(Baseline)
- Infant daily cry duration(6 weeks)
- Infant daily fuss duration(Baseline, 6 and 12 weeks of age)
- Infant daily fuss duration(Baseline)
- Infant daily sleep duration(Baseline)
- Infant daily sleep duration(6 weeks)
- Parent (female and male) mental health(Baseline)
- Parent (female and male) mental health(6 weeks)
- Parent (female and male) fatigue(Baseline)
- Parent (female and male) fatigue(6 weeks)
- Gut microbial composition, diversity and function(Baseline)
- Gut microbial composition, diversity and function(6 weeks)
- Adverse effects - digestive upset(8 weeks)
- Adverse effects - growth/length(8 weeks)
- Adverse effects - growth/weight(8 weeks)
- Adverse effects - growth/head circumference(8 weeks)
- Health services utilization(Baseline)
- Health services utilization(6 weeks)
研究者
Patricia Parkin
Professor, Senior Associate Scientist, Staff Pediatrician
The Hospital for Sick Children