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PRobiotics for EVEry Newborn Trial (PREVENT)

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ClinicalTrials.gov Identifier: NCT04537494
Recruitment Status : Not yet recruiting
First Posted : September 3, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Patricia Parkin, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colic Infantile Dietary Supplement: L. reuteri Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREVENT: PRobiotics for EVEry Newborn vs Treatment-as-Needed Comparative Effectiveness Trial
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : May 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prevention
Oral supplementation with the probiotic L. reuteri administered to every newborn within the first week of life for 12 weeks
 Dietary Supplement: L. reuteri
Probiotic
Other Name: BioGaia
Treatment-as-needed
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
Probiotic
Other Name: BioGaia


Outcome Measures
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Primary Outcome Measures :
  1. Combined infant daily cry/fuss duration [ Time Frame: Baseline ]
    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.

  2. Combined infant daily cry/fuss duration [ Time Frame: 6 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.

  3. Combined infant daily cry/fuss duration [ Time Frame: 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 :
  1. Infant daily cry duration [ Time Frame: Baseline ]
    Daily cry duration will be examined separately

  2. Infant daily cry duration [ Time Frame: 6 weeks ]
    Daily cry duration will be examined separately

  3. Infant daily cry duration [ Time Frame: 12 weeks ]
    Daily cry duration will be examined separately

  4. Infant daily fuss duration [ Time Frame: Baseline, 6 and 12 weeks of age ]
    Daily fuss duration will be examined separately

  5. Infant daily fuss duration [ Time Frame: Baseline ]
    Daily fuss duration will be examined separately

  6. Infant daily fuss duration [ Time Frame: 6 weeks ]
    Daily fuss duration will be examined separately

  7. Infant colic [ Time Frame: 12 weeks ]
    Daily cry/fuss of at least 180 minutes

  8. Infant daily sleep duration [ Time Frame: Baseline ]
    Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.

  9. Infant daily sleep duration [ Time Frame: 6 weeks ]
    Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.

  10. Infant daily sleep duration [ Time Frame: 12 weeks ]
    Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.

  11. Parent (female and male) mental health [ Time Frame: Baseline ]
    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.

  12. Parent (female and male) mental health [ Time Frame: 6 weeks ]
    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.

  13. Parent (female and male) mental health [ Time Frame: 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.

  14. Parent (female and male) fatigue [ Time Frame: Baseline ]
    Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome

  15. Parent (female and male) fatigue [ Time Frame: 6 weeks ]
    Fatigue will be measured using a validated Fatigue Visual Analogue Scale. Scores will range between 0 and 180, higher score means worse outcome.

  16. Parent (female and male) fatigue [ Time Frame: 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

  17. Gut microbial composition, diversity and function [ Time Frame: Baseline ]
    Microbial composition, diversity and function will be measured in infant fecal samples.

  18. Gut microbial composition, diversity and function [ Time Frame: 6 weeks ]
    Microbial composition, diversity and function will be measured in infant fecal samples.

  19. Gut microbial composition, diversity and function [ Time Frame: 12 weeks ]
    Microbial composition, diversity and function will be measured in infant fecal samples.

  20. Adverse effects - digestive upset [ Time Frame: 8 weeks ]
    Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary

  21. Adverse effects - digestive upset [ Time Frame: 16 weeks ]
    Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary

  22. Adverse effects - growth/length [ Time Frame: 8 weeks ]
    Infant growth (length) will be measured at scheduled health supervision visits

  23. Adverse effects - growth/weight [ Time Frame: 8 weeks ]
    Infant growth (weight) will be measured at scheduled health supervision visits

  24. Adverse effects - growth/head circumference [ Time Frame: 8 weeks ]
    Infant growth (head circumference) will be measured at scheduled health supervision visits

  25. Adverse effects - growth/length [ Time Frame: 16 weeks ]
    Infant growth (length) will be measured at scheduled health supervision visits

  26. Adverse effects - growth/weight [ Time Frame: 16 weeks ]
    Infant growth (weight) will be measured at scheduled health supervision visits

  27. Adverse effects - growth/head circumference [ Time Frame: 16 weeks ]
    Infant growth (head circumference) will be measured at scheduled health supervision visits

  28. Health services utilization [ Time Frame: Baseline ]
    Frequency of assessments

  29. Health services utilization [ Time Frame: 6 weeks ]
    Frequency of assessments

  30. Health services utilization [ Time Frame: 12 weeks ]
    Frequency of assessments


Eligibility Criteria
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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537494


Contacts
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Contact: Dalah C. Mason, MPH 416-813-7654 ext 302129 dalah.mason@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Patricia Parkin, MD The Hospital for Sick Children
Principal Investigator: Patricia Li, MD The Research Institute of the McGill University Health Centre
More Information
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Responsible Party: Patricia Parkin, Professor, Senior Associate Scientist, Staff Pediatrician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04537494    
Other Study ID Numbers: 1000064700
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Patricia Parkin, The Hospital for Sick Children:
Colic
Probiotic
Infant
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases