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NCT Number: NCT07665983

The Bottle Optimization Testing Tiny Little Eaters Study

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.

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Key information

Age range

4 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Amanda Crandall, PhD

PRINCIPAL_INVESTIGATOR

Bryanne Caldwell

CONTACT

[email protected]

734-647-8100

About this study

The study will enroll 220 mother-infant dyads.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

  1. 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)

    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

Secondary outcomes

  1. Change in suck effect (Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Measured with smart bottles and defined as the area under the sucking curve across a single feeding.

  2. Change in peak tongue pressure ((Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Measured with smart bottles and defined as the average peak of the sucking curves across a single feeding.

  3. Change in sucking frequency (Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Measured with smart bottles and defined as the average number of full suck cycles per second across a single feeding.

  4. Change in sucking smoothness ((Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Measured with smart bottles and defined as the average number of sucking pattern peaks in the speed profile of a suck across a single feeding.

  5. Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Calculated as the mean Feeding Interval during the given 12-hour segment on the Slower Flow day minus the mean Feeding Interval during the matching 12-hour segment Typical nipple day.

  6. Change in satiation signaling (Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Coded set of behaviors from video recordings of feeding interactions associated with infant disengagement from the bottle or caregiver.

  7. Change in dyadic mutuality between infant and caregiver (Δ^(S-T))

    Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)

    Coded from video-recordings of feeding interactions, based on behaviors associated with strong communication, warmth, and synchrony of the dyad.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryanne Caldwell

CONTACT

[email protected]

734-647-8100

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions

Acronym: BOTTLE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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