University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
NCT Number: NCT07665983
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.
Interested in participating?
Request Info4 month and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
The study will enroll 220 mother-infant dyads.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
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)
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)
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)
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)
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)
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.
Time frame: From baseline to the end of the slower flow feeding phase (approximately 4 days later)
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)
Coded from video-recordings of feeding interactions, based on behaviors associated with strong communication, warmth, and synchrony of the dyad.
Contact information is provided by the study sponsor or research team.
University of Michigan
Other
Managing Excess Infant Energy Intake by Increasing Satiation Responsiveness in Dyadic Feeding Interactions
Acronym: BOTTLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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