PRobiotics for EVEry Newborn Trial
- Conditions
- ColicInfantile
- Interventions
- Dietary Supplement: L. reuteri
- Registration Number
- NCT04537494
- Lead Sponsor
- The Hospital for Sick Children
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 1 to 7 days of age
- term (37 to 41 weeks)
- breast or formula fed
- birth weight > 2500 grams
- parental consent
- congenital or other medical disorders
- parents unable to communicate in English or French
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment-as-needed L. reuteri Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age Prevention L. reuteri Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
- Primary Outcome Measures
Name Time Method Combined infant daily cry/fuss duration 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.
- Secondary Outcome Measures
Name Time Method Infant daily fuss duration 6 weeks Daily fuss duration will be examined separately
Gut microbial composition, diversity and function 12 weeks Microbial composition, diversity and function will be measured in infant fecal samples.
Infant colic 12 weeks Daily cry/fuss of at least 180 minutes
Infant daily cry duration 12 weeks Daily cry duration will be examined separately
Parent (female and male) fatigue 12 weeks Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome
Adverse effects - growth/length 16 weeks Infant growth (length) will be measured at scheduled health supervision visits
Adverse effects - growth/head circumference 16 weeks Infant growth (head circumference) will be measured at scheduled health supervision visits
Health services utilization 12 weeks Frequency of assessments
Infant daily sleep duration 12 weeks Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Parent (female and male) mental health 12 weeks Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scoring is between o and 30 and higher score means worse outcome.
Adverse effects - digestive upset 16 weeks Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Adverse effects - growth/weight 16 weeks Infant growth (weight) will be measured at scheduled health supervision visits
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada