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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
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colic focused on measuring Colic, Probiotic, Infant

Eligibility Criteria

1 Day - 7 Days (Child)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    January 27, 2020
    Last Updated
    February 9, 2021
    Sponsor
    The Hospital for Sick Children
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    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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