Bottle flow-rate test for babies and feeding patterns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this interventional study, researchers will compare infant feeding behavior when using bottles with nipples that have different flow rates over several days. The goal is to see if nipple flow influences milk intake, feeding duration, and sleep patterns in healthy, term infants. About 220 mother–infant dyads will participate, with at-home assessments and visits to the U-M North Campus research site as needed. Eligible families are English-speaking, reside near Ann Arbor, and have infants aged 4–6 months who currently bottle-feed at least weekly. Exclusion criteria include maternal depression or anxiety that is currently present.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Amanda Crandall, PhD — University of Michigan
• Study coordinator: Bryanne Caldwell
• Email: bmcaldwe@umich.edu
• Phone: 734-647-8100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.