The Bottle Optimization Testing Tiny Little Eaters Study
Recruiting · NCT07665983 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Feeding
What this trial 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.
Who can take part
Age range
4 Months and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States