PRobiotics for EVEry Newborn Trial

Colic Clinical Trial

— PREVENT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04537494
• Other study ID #: 1000064700
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: February 2021
• Source: The Hospital for Sick Children
• Contact: Dalah C. Mason, MPH
• Phone: 416-813-7654
• Email: dalah.mason[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Infantile

Intervention

Dietary Supplement:
• L. reuteri
Probiotic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Infant daily cry duration	Daily cry duration will be examined separately	Baseline
Secondary	Infant daily cry duration	Daily cry duration will be examined separately	6 weeks
Secondary	Infant daily cry duration	Daily cry duration will be examined separately	12 weeks
Secondary	Infant daily fuss duration	Daily fuss duration will be examined separately	Baseline, 6 and 12 weeks of age
Secondary	Infant daily fuss duration	Daily fuss duration will be examined separately	Baseline
Secondary	Infant daily fuss duration	Daily fuss duration will be examined separately	6 weeks
Secondary	Infant colic	Daily cry/fuss of at least 180 minutes	12 weeks
Secondary	Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	Baseline
Secondary	Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	6 weeks
Secondary	Infant daily sleep duration	Sleep duration will be measured objectively using actigraphy worn around the infant's ankle over a sock.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	Baseline
Secondary	Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	6 weeks
Secondary	Gut microbial composition, diversity and function	Microbial composition, diversity and function will be measured in infant fecal samples.	12 weeks
Secondary	Adverse effects - digestive upset	Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary	8 weeks
Secondary	Adverse effects - digestive upset	Number of participants with occurrences of digestive upset (e.g., diarrhea), in the Baby's Day Diary	16 weeks
Secondary	Adverse effects - growth/length	Infant growth (length) will be measured at scheduled health supervision visits	8 weeks
Secondary	Adverse effects - growth/weight	Infant growth (weight) will be measured at scheduled health supervision visits	8 weeks
Secondary	Adverse effects - growth/head circumference	Infant growth (head circumference) will be measured at scheduled health supervision visits	8 weeks
Secondary	Adverse effects - growth/length	Infant growth (length) will be measured at scheduled health supervision visits	16 weeks
Secondary	Adverse effects - growth/weight	Infant growth (weight) will be measured at scheduled health supervision visits	16 weeks
Secondary	Adverse effects - growth/head circumference	Infant growth (head circumference) will be measured at scheduled health supervision visits	16 weeks
Secondary	Health services utilization	Frequency of assessments	Baseline
Secondary	Health services utilization	Frequency of assessments	6 weeks
Secondary	Health services utilization	Frequency of assessments	12 weeks