Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

June 22, 2016 updated by: Mead Johnson Nutrition
The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Northwest Arkansas Pediatric Clinic
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatrics
    • Indiana
      • Evansville, Indiana, United States, 47725
        • Deaconess Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Universty of Kansas Medical Center
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
        • Woburn Pediatrics
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Pediatric Associates of Mt. Carmel
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton, 14-35 days of age at baseline
  • Term infant with birth weight of a minimum of 2500 grams
  • Solely formula-fed
  • Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

  • History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
  • Feeding difficulties or formula intolerance
  • Maternal history of illicit drug use or psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Previously marketed cow's milk-based infant formula
Other: Previously marketed cow's mlik-based infant formula
Experimental: Marketed cow's milk-based infant formula with prebiotics
Other: Marketed cow's milk-based infant formula with prebiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep Measures (Amount of time awake and asleep in a 72 hour period)
Time Frame: 14 weeks
14 weeks
Infant State (Infant behavior over a 72 hour period)
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieved Weight
Time Frame: 14 weeks
Total weight gain
14 weeks
Achieved Length
Time Frame: 14 weeks
Total length gain
14 weeks
Achieved Head Circumference
Time Frame: 14 weeks
Total head circumference gain
14 weeks
Formula Intake
Time Frame: 14 weeks
14 weeks
Fecal microbiome
Time Frame: Baseline and 112 days of age
Baseline and 112 days of age
Medically-confirmed Adverse Events
Time Frame: 14 weeks
14 weeks
Salivary Cortisol levels
Time Frame: 70 and 120 days of age
70 and 120 days of age
Temperament - Infant Behavior Questionnaire
Time Frame: Once at 112 days of age
Once at 112 days of age
Sleep Characteristics
Time Frame: 14 weeks
Amount of waking and sleeping, number of waking and sleep episodes
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 18, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 6023 (CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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