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 study will enroll 220 mother-infant dyads.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
440
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).
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGChange 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)
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)
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)
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)
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)
Change in feeding Interval for each of the 12-hour segments post-introduction of the Slower-Flow bottle nipple
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.
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Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
Change in satiation signaling (Δ^(S-T))
Coded set of behaviors from video recordings of feeding interactions associated with infant disengagement from the bottle or caregiver.
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))
Coded from video-recordings of feeding interactions, based on behaviors associated with strong communication, warmth, and synchrony of the dyad.
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)