Clinical trial NCT04537494: PRobiotics for EVEry Newborn Trial
Official title: PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic
Infantile
Keywords: Colic
Probiotic
Infant
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. 1 to 7 days of age
2. term (37 to 41 weeks)
3. breast or formula fed
4. birth weight \> 2500 grams
5. parental consent

Exclusion Criteria:

1. congenital or other medical disorders
2. parents unable to communicate in English or French

Primary outcomes:
measure: Combined infant daily cry/fuss duration
timeFrame: Baseline
measure: Combined infant daily cry/fuss duration
timeFrame: 6 weeks
measure: Combined infant daily cry/fuss duration
timeFrame: 12 weeks
Secondary outcomes:
measure: Infant daily cry duration
timeFrame: Baseline
measure: Infant daily cry duration
timeFrame: 6 weeks
measure: Infant daily cry duration
timeFrame: 12 weeks
measure: Infant daily fuss duration
timeFrame: Baseline, 6 and 12 weeks of age
measure: Infant daily fuss duration
timeFrame: Baseline
measure: Infant daily fuss duration
timeFrame: 6 weeks
measure: Infant colic
timeFrame: 12 weeks
measure: Infant daily sleep duration
timeFrame: Baseline
measure: Infant daily sleep duration
timeFrame: 6 weeks
measure: Infant daily sleep duration
timeFrame: 12 weeks
measure: Parent (female and male) mental health
timeFrame: Baseline
measure: Parent (female and male) mental health
timeFrame: 6 weeks
measure: Parent (female and male) mental health
timeFrame: 12 weeks
measure: Parent (female and male) fatigue
timeFrame: Baseline
measure: Parent (female and male) fatigue
timeFrame: 6 weeks
measure: Parent (female and male) fatigue
timeFrame: 12 weeks
measure: Gut microbial composition, diversity and function
timeFrame: Baseline
measure: Gut microbial composition, diversity and function
timeFrame: 6 weeks
measure: Gut microbial composition, diversity and function
timeFrame: 12 weeks
measure: Adverse effects - digestive upset
timeFrame: 8 weeks
measure: Adverse effects - digestive upset
timeFrame: 16 weeks
measure: Adverse effects - growth/length
timeFrame: 8 weeks
measure: Adverse effects - growth/weight
timeFrame: 8 weeks
measure: Adverse effects - growth/head circumference
timeFrame: 8 weeks
measure: Adverse effects - growth/length
timeFrame: 16 weeks
measure: Adverse effects - growth/weight
timeFrame: 16 weeks
measure: Adverse effects - growth/head circumference
timeFrame: 16 weeks
measure: Health services utilization
timeFrame: Baseline
measure: Health services utilization
timeFrame: 6 weeks
measure: Health services utilization
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Patricia Parkin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Research Institute of the McGill University Health Centre
name: Patricia Li, MD
role: PRINCIPAL_INVESTIGATOR
References: