NCT07665983 · University of Michigan
The Bottle Optimization Testing Tiny Little Eaters Study
(BOTTLE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Current weight-for-age below the 10th percentile or significant history of poor weight gain.
- Infant already typically uses a slower-flow nipple (flow rate \< 5 mL/min).
Where
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations