PRobiotics for EVEry Newborn Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial

Conditions
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Colic, Infantile

Intervention / Treatment
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* Dietary Supplement: L. reuteri


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prevention<br>Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks | Dietary Supplement: L. reuteri<br>* Probiotic<br>* Other names: BioGaia;|
| Other: Treatment-as-needed<br>Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age | Dietary Supplement: L. reuteri<br>* Probiotic<br>* Other names: BioGaia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined infant daily cry/fuss duration | 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. | Baseline | 
| Combined infant daily cry/fuss duration | 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. | 6 weeks | 
| Combined infant daily cry/fuss duration | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant daily cry duration | Daily cry duration will be examined separately | Baseline | 
| Infant daily cry duration | Daily cry duration will be examined separately | 6 weeks | 
| Infant daily cry duration | Daily cry duration will be examined separately | 12 weeks | 
| Infant daily fuss duration | Daily fuss duration will be examined separately | Baseline, 6 and 12 weeks of age | 
| Infant daily fuss duration | Daily fuss duration will be examined separately | Baseline | 
| Infant daily fuss duration | Daily fuss duration will be examined separately | 6 weeks | 
| Infant colic | Daily cry/fuss of at least 180 minutes | 12 weeks | 
| Infant daily sleep duration | Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock. | Baseline | 
| Infant daily sleep duration | Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock. | 6 weeks | 
| Infant daily sleep duration | Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock. | 12 weeks | 
| Parent (female and male) mental health | Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scores range between 0 and 30 and higher scores mean worse outcome. | Baseline | 
| Parent (female and male) mental health | Mental health will be measured using the Edinburgh Postnatal Depression Scale, a validated 10-item screening questionnaire. Scores range between 0 and 30 and higher score means worse outcome. | 6 weeks | 
| Parent (female and male) mental health | 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. | 12 weeks | 
| Parent (female and male) fatigue | Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome | Baseline | 
| Parent (female and male) fatigue | Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome. | 6 weeks | 
| Parent (female and male) fatigue | Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome | 12 weeks | 
| Gut microbial composition, diversity and function | Microbial composition, diversity and function will be measured in infant fecal samples. | Baseline | 
| Gut microbial composition, diversity and function | Microbial composition, diversity and function will be measured in infant fecal samples. | 6 weeks | 
| Gut microbial composition, diversity and function | Microbial composition, diversity and function will be measured in infant fecal samples. | 12 weeks | 
| Adverse effects - digestive upset | Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary | 8 weeks | 
| Adverse effects - digestive upset | Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary | 16 weeks | 
| Adverse effects - growth/length | Infant growth (length) will be measured at scheduled health supervision visits | 8 weeks | 
| Adverse effects - growth/weight | Infant growth (weight) will be measured at scheduled health supervision visits | 8 weeks | 
| Adverse effects - growth/head circumference | Infant growth (head circumference) will be measured at scheduled health supervision visits | 8 weeks | 
| Adverse effects - growth/length | Infant growth (length) will be measured at scheduled health supervision visits | 16 weeks | 
| Adverse effects - growth/weight | Infant growth (weight) will be measured at scheduled health supervision visits | 16 weeks | 
| Adverse effects - growth/head circumference | Infant growth (head circumference) will be measured at scheduled health supervision visits | 16 weeks | 
| Health services utilization | Frequency of assessments | Baseline | 
| Health services utilization | Frequency of assessments | 6 weeks | 
| Health services utilization | Frequency of assessments | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colic, Probiotic, Infant