Infant Feeding BehaviorNCT01526018
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
An observational study of Infant Feeding Behavior, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Feeding Behavior
- What is being tested?
- Podee bottle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Bottle-fed infants aged 1-6 months
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
- Conditions
- Infant Feeding Behavior
- Being tested
- Podee bottle
- Keywords
- Intake, Formula feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Podee bottleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Novel bottle | Not described Receives: Behavioral: Podee bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Rate of intake, volume of intake, duration of meal
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Chandler-Laney, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526018
- Sponsor's protocol ID
- F110921001
- Status last verified
- Aug 2014
- First submitted
- 31 Jan 2012
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
- ClinicalTrials.gov ID
- NCT01526018
- Acronym / sponsor ID
- F110921001
- Conditions
- Infant Feeding Behavior
- Keywords
- Intake, Formula feeding
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel bottle | – | Behavioral: Podee bottle |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Bottle-fed infants aged 1-6 months
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Podee bottleInfants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles. | Behavioural | Novel bottle |
Primary outcome
Food intake
Time frame: 2 weeks
Rate of intake, volume of intake, duration of meal
Results and safety
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Feeding Behavior, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.