Clinical trial

The Bottle Optimization Testing Tiny Little Eaters Study

Recruiting now · Not applicable · 1 countries · Registry ID NCT07665983

Recruiting nowNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age4 Months to Not listed
SexAll
Healthy volunteersAccepted
ConditionChildhood Obesity

Full registry criteria

Inclusion Criteria: 1. 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). 2. Maternal age: Mother is ≥18 years old. 3. Language: Mother understands spoken and written English sufficiently to provide informed consent, answer questionnaires and follow study instructions. 4. Gestational age: Infant was born at 37.0-42.0 weeks gestation. 5. Birthweight: Infant's birthweight was appropriate for gestational age. 6. Bottle feeding: Infant currently receives at least one bottle feeding of ≥2 ounces at least once per week. 7. 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. 8. Infant age: Infant is 4.0-6.0 months old at enrollment. Exclusion Criteria: 1. Current maternal depression or anxiety, as assessed by screening questionnaires, or any cognitive impairment that would limit ability to follow study instructions. 2. Infant developmental delay, genetic condition, or medical problems or diagnosis affecting current or future eating, growth, or development. 3. History of significant sucking or feeding difficulties or breastfeeding difficulties requiring significant medical intervention or support. 4. Current weight-for-age below the 10th percentile or significant history of poor weight gain. 5. Infant already typically uses a slower-flow nipple (flow rate \< 5 mL/min).

Treatments and study arms

Feeding

Behavioral

Following a baseline day (Day 1) in which infants are fed with their typical nipple, infants are exposed to a commercially available nipple with a 30 percent reduced flow rate for three consecutive days (Days 2-4).

Primary outcomes

Change in milk/formula intake (Δ^(S-T))From baseline to the end of the slower flow feeding phase (approximately 4 days later)

Calculated as intake (pre-weight minus post-weight divided by infant body weight) during each slower-flow feeding minus the mean intake across the three baseline feedings

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Michigan🇺🇸 Ann Arbor, Michigan, United States
Bryanne CaldwellContact
Amanda Crandall, PhDPrincipal Investigator