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Clinical Trials/NCT01526018
NCT01526018
Terminated
N/A

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

University of Alabama at Birmingham1 site in 1 country5 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant Feeding Behavior
Sponsor
University of Alabama at Birmingham
Enrollment
5
Locations
1
Primary Endpoint
Food intake
Status
Terminated
Last Updated
11 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
January 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paula Chandler-Laney, PhD

Assistant Professor

University of Alabama at Birmingham

Eligibility 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.

Outcomes

Primary Outcomes

Food intake

Time Frame: 2 weeks

Rate of intake, volume of intake, duration of meal

Study Sites (1)

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