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Testing How Bottle Nipple Flow Rate Affects Milk Intake in Babies

Tests different bottle nipple flow rates and how much milk babies drink.

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, United StatesSee the site
Trial code
Registry title
The Bottle Optimization Testing Tiny Little Eaters Study
Status
Recruiting
People taking part
440 people, planned
Started
26 Jun 2026
Expected to end
Aug 2028
Type of study
Interventional
Treatments tested
  • Feeding
Record updated
1 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for mothers with a 4 to 6 month old baby who gets at least one bottle feed a week. It studies how nipple flow rate affects milk intake, feeding and sleep.

Age
Mother: 18 years or older. Baby: 4.0 to 6.0 months old at enrollment.
Sex
Babies of any sex can join.

Main reasons for not taking part

  • Mother currently has depression or anxiety, or a cognitive impairment that limits following the study instructions
  • Baby has a developmental delay, genetic condition or medical problem affecting eating, growth or development
  • Baby has had significant sucking, feeding or breastfeeding difficulties needing medical support
  • Baby's weight for age is below the 10th percentile, or baby had poor weight gain
  • Baby already uses a slower-flow nipple (under 5 mL/min)

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in United States

  • University of MichiganAnn Arbor, United StatesContact: Bryanne CaldwellTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Mother-infant dyadTreatment being tested

    Each mother-infant dyad serves as its own control.

    Treatment: Feeding

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
Plain-language title
Testing How Bottle Nipple Flow Rate Affects Milk Intake in BabiesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 July 2026