PRobiotics for EVEry Newborn Trial (PREVENT)
Primary Purpose
Colic, Infantile
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
L. reuteri
Sponsored by
About this trial
This is an interventional prevention trial for Colic focused on measuring Colic, Probiotic, Infant
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Prevention
Treatment-as-needed
Arm Description
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Infant daily cry duration
Daily cry duration will be examined separately
Infant daily cry duration
Daily cry duration will be examined separately
Infant daily cry duration
Daily cry duration will be examined separately
Infant daily fuss duration
Daily fuss duration will be examined separately
Infant daily fuss duration
Daily fuss duration will be examined separately
Infant daily fuss duration
Daily fuss duration will be examined separately
Infant colic
Daily cry/fuss of at least 180 minutes
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Infant daily sleep duration
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
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.
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.
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.
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
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.
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
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Gut microbial composition, diversity and function
Microbial composition, diversity and function will be measured in infant fecal samples.
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Adverse effects - digestive upset
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Adverse effects - growth/length
Infant growth (length) will be measured at scheduled health supervision visits
Adverse effects - growth/weight
Infant growth (weight) will be measured at scheduled health supervision visits
Adverse effects - growth/head circumference
Infant growth (head circumference) will be measured at scheduled health supervision visits
Health services utilization
Frequency of assessments
Health services utilization
Frequency of assessments
Health services utilization
Frequency of assessments
Full Information
NCT ID
NCT04537494
First Posted
January 27, 2020
Last Updated
February 9, 2021
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT04537494
Brief Title
PRobiotics for EVEry Newborn Trial
Acronym
PREVENT
Official Title
PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic, Infantile
Keywords
Colic, Probiotic, Infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prevention
Arm Type
Active Comparator
Arm Description
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
Arm Title
Treatment-as-needed
Arm Type
Other
Arm Description
Supplementation with the probiotic L. reuteri after randomization, to infants who develop excessive cry/fuss up to 12 weeks of age
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri
Other Intervention Name(s)
BioGaia
Intervention Description
Probiotic
Primary Outcome Measure Information:
Title
Combined infant daily cry/fuss duration
Description
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.
Time Frame
Baseline
Title
Combined infant daily cry/fuss duration
Description
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.
Time Frame
6 weeks
Title
Combined infant daily cry/fuss duration
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Infant daily cry duration
Description
Daily cry duration will be examined separately
Time Frame
Baseline
Title
Infant daily cry duration
Description
Daily cry duration will be examined separately
Time Frame
6 weeks
Title
Infant daily cry duration
Description
Daily cry duration will be examined separately
Time Frame
12 weeks
Title
Infant daily fuss duration
Description
Daily fuss duration will be examined separately
Time Frame
Baseline, 6 and 12 weeks of age
Title
Infant daily fuss duration
Description
Daily fuss duration will be examined separately
Time Frame
Baseline
Title
Infant daily fuss duration
Description
Daily fuss duration will be examined separately
Time Frame
6 weeks
Title
Infant colic
Description
Daily cry/fuss of at least 180 minutes
Time Frame
12 weeks
Title
Infant daily sleep duration
Description
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time Frame
Baseline
Title
Infant daily sleep duration
Description
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time Frame
6 weeks
Title
Infant daily sleep duration
Description
Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.
Time Frame
12 weeks
Title
Parent (female and male) mental health
Description
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.
Time Frame
Baseline
Title
Parent (female and male) mental health
Description
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.
Time Frame
6 weeks
Title
Parent (female and male) mental health
Description
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.
Time Frame
12 weeks
Title
Parent (female and male) fatigue
Description
Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome
Time Frame
Baseline
Title
Parent (female and male) fatigue
Description
Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome.
Time Frame
6 weeks
Title
Parent (female and male) fatigue
Description
Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome
Time Frame
12 weeks
Title
Gut microbial composition, diversity and function
Description
Microbial composition, diversity and function will be measured in infant fecal samples.
Time Frame
Baseline
Title
Gut microbial composition, diversity and function
Description
Microbial composition, diversity and function will be measured in infant fecal samples.
Time Frame
6 weeks
Title
Gut microbial composition, diversity and function
Description
Microbial composition, diversity and function will be measured in infant fecal samples.
Time Frame
12 weeks
Title
Adverse effects - digestive upset
Description
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Time Frame
8 weeks
Title
Adverse effects - digestive upset
Description
Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary
Time Frame
16 weeks
Title
Adverse effects - growth/length
Description
Infant growth (length) will be measured at scheduled health supervision visits
Time Frame
8 weeks
Title
Adverse effects - growth/weight
Description
Infant growth (weight) will be measured at scheduled health supervision visits
Time Frame
8 weeks
Title
Adverse effects - growth/head circumference
Description
Infant growth (head circumference) will be measured at scheduled health supervision visits
Time Frame
8 weeks
Title
Adverse effects - growth/length
Description
Infant growth (length) will be measured at scheduled health supervision visits
Time Frame
16 weeks
Title
Adverse effects - growth/weight
Description
Infant growth (weight) will be measured at scheduled health supervision visits
Time Frame
16 weeks
Title
Adverse effects - growth/head circumference
Description
Infant growth (head circumference) will be measured at scheduled health supervision visits
Time Frame
16 weeks
Title
Health services utilization
Description
Frequency of assessments
Time Frame
Baseline
Title
Health services utilization
Description
Frequency of assessments
Time Frame
6 weeks
Title
Health services utilization
Description
Frequency of assessments
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalah C. Mason, MPH
Phone
416-813-7654
Ext
302129
Email
dalah.mason@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Parkin, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Li, MD
Organizational Affiliation
The Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PRobiotics for EVEry Newborn Trial
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