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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99HD112517-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-infant dyad | Experimental | Each mother-infant dyad serves as its own control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to the end of the slower flow feeding phase (approximately 4 days later) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in suck effect (Δ^(S-T)) | Measured with smart bottles and defined as the area under the sucking curve across a single feeding. | From baseline to the end of the slower flow feeding phase (approximately 4 days later) |
| Change in peak tongue pressure ((Δ^(S-T)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryanne Caldwell | Contact | 734-647-8100 | bmcaldwe@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amanda Crandall, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
The researchers will upload the study data to Deep Blue Data. Video-recordings and raw sucking data will not be included in the archived data on Deep Blue Data and will only be shared under appropriate data use agreements.
"Deep Blue Data provides access to digital research data that were developed or used in the support of research activities at U-M. All data in the repository are available for anyone to download without restriction." https://www.lib.umich.edu/collections/deep-blue-repositories
Data will be available by August 2029 and the researchers will leave it up a minimum of 3 years.
"All data in the repository are available for anyone to download without restriction." The data not in the repository, ideo-recordings and raw sucking data, University investigators pending approval of data sharing agreement.
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Measured with smart bottles and defined as the average peak of the sucking curves across a single feeding. |
| 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. | 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. | 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. | 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. | 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. | From baseline to the end of the slower flow feeding phase (approximately 4 days later) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |