The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Information provided by (Responsible Party):
Paula Chandler-Laney, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01526018
First received: January 31, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle. Exclusively formula-fed infants and their caregiver will be provided with the novel feeding bottle and caregivers will be asked to acclimate their infant to this bottle during the next several weeks. Once acclimated, infants will undergo two weighed, timed, and videotaped test meals on two separate days; one with the novel bottle and one with their standard bottle, in random order. It is hypothesized that when the novel bottle is used, infants bottle will consume smaller meals and will have a longer meal duration, as compared to when a standard bottle is used.


Condition Intervention
Infant Feeding Behavior
Behavioral: Podee bottle

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Food intake [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Rate of intake, volume of intake, duration of meal


Enrollment: 5
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Novel bottle Behavioral: Podee bottle
Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Bottle-fed infants aged 1-6 months

Criteria

Inclusion Criteria:

  • healthy, exclusively formula-fed infants aged 1-6 months at enrollment;
  • parent must be at least 19 years of age, able to understand written and verbal English, and provide daytime care for the infant at least 4 days per week.

Exclusion Criteria:

  • born < 37 weeks;
  • birth weight < 2500g or > 4000g;
  • current weight < 10th percentile for age;
  • hospitalization > 72 hours following birth or any hospital admission since birth;
  • any health issue that could interfere with feeding and/or growth;
  • use of complementary foods;
  • inability or unwillingness to comply with study-related procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526018

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Paula Chandler-Laney, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01526018     History of Changes
Other Study ID Numbers: F110921001
Study First Received: January 31, 2012
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Intake
Formula feeding

ClinicalTrials.gov processed this record on August 21, 2014