The Bottle Optimization Testing Tiny Little Eaters Study

Official title

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

Overview

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.

Detailed description

The study will enroll 220 mother-infant dyads.

Interventions

• Behavioral 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 measures

• 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)]

Secondary outcome measures (7)

• Change in suck effect (Δ^(S-T)) [Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
• 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)]
• Change in sucking frequency (Δ^(S-T)) [Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
• Change in sucking smoothness ((Δ^(S-T)) [Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
• 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)]
• Change in satiation signaling (Δ^(S-T)) [Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)]
• 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)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07665983 · HUM00278538 · 1K99HD112517-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗