Recruiting

Bottle Nipples

Sponsor:

University of Michigan

Code:

NCT07665983

Conditions

Childhood Obesity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Feeding

Study Details

Brief summary:

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.

Conditions

Childhood Obesity

Study ID

NCT07665983

Start date

Jun 26, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

440 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Mother-infant dyad

Each mother-infant dyad serves as its own control.

Interventions

Feeding

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 outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Amanda Crandall, PhD

More Information

Sponsor

University of Michigan

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Infant growth
  • Responsive feeding
  • Satiation cues
  • Milk intake

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-01.