The Bottle Optimization Testing Tiny Little Eaters Study
ConditionChildhood Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Feeding
BehavioralFollowing 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).
Treatment groups
440 Participants
are divided into 1 treatment groupGroup A: Mother-infant dyadExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in milk/formula intake (Δ^(S-T))
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
Time frame
From baseline to the end of the slower flow feeding phase (approximately 4 days later)Secondary outcomes
1
Change in suck effect (Δ^(S-T))
Measured with smart bottles and defined as the area under the sucking curve across a single feeding.
Time frame
From baseline to the end of the slower flow feeding phase (approximately 4 days later)2
Change in peak tongue pressure ((Δ^(S-T))
Measured with smart bottles and defined as the average peak of the sucking curves across a single feeding.
Time frame
From baseline to the end of the slower flow feeding phase (approximately 4 days later)3
Change in sucking frequency (Δ^(S-T))
Measured with smart bottles and defined as the average number of full suck cycles per second across a single feeding.
Time frame
From baseline to the end of the slower flow feeding phase (approximately 4 days later)4
Change in sucking smoothness ((Δ^(S-T))
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.
Time frame
From baseline to the end of the slower flow feeding phase (approximately 4 days later)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov