NCT07665983Recruiting
The Bottle Optimization Testing Tiny Little Eaters Study
Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
The researchers will study how babies respond to bottle nipples with different flow rates over a few days, and how this may affect how much milk they drink, their feeding patterns, and their sleep.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- 26 Jun 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- University of Michigan
- Diseases
- Obesity
- NCT number
- NCT07665983
What you commit to
- Study type: Interventional
- Planned participants: 440
- From 26 Jun 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions.
- Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development.
- History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support.
Age
- Current weight-for-age below the 10th percentile or significant history of poor weight gain.
Other
- Infant already typically uses a slower-flow nipple (flow rate \< 5 mL/min).
Who the study is looking for
- Mother-infant dyad: The biological mother is the legal guardian of the infant and has custody for ≥5 days per week (in cases of joint custody).
- Maternal age: Mother is ≥18 years old.
- Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions.
- Gestational age: Infant was born at 37.0-42.0 weeks gestation.
- Birthweight: Infant's birthweight was appropriate for gestational age.
- Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week.
- Residence: Family lives within approximately one hours driving distance of Ann Arbor, Michigan to participate in an at- home appointment or is willing to drive to the U-M North Campus research site.
- Infant age: Infant is 4.0-6.0 months old at enrollment.
Age in the registry: 4 months to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.