PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Combined infant daily cry/fuss duration
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
For the 2 Randomized arms, all parties were masked. For the 2 Parent Preference arms, all parties were unmasked (open label)
Eligibility Criteria
- Ages
- 1 Day to 7 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1 to 7 days of age
- •term (37 to 41 weeks)
- •breast or formula fed
- •birth weight > 2500 grams
- •parental consent
Exclusion Criteria
- •congenital or other medical disorders
- •parents unable to communicate in English or French
Arms & Interventions
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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: L. reuteri (Dietary Supplement)
Outcomes
Primary Outcomes
Combined infant daily cry/fuss duration
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Patricia Parkin
Professor, Senior Associate Scientist, Staff Pediatrician
The Hospital for Sick Children