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In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants
In this parallel-group randomized controlled trial, ELBW infants (birthweight < 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reporting of sucking patterns captured by Instrumented Bottle | Experimental | Weekly reporting on objective measurements of sucking activity during oral feeding |
|
| Control | Sham Comparator | Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reporting of sucking patterns captured by Instrumented Bottle | Diagnostic Test | In the intervention group, data on nutritive sucking and feeding cues captured by the Instrumented Bottle will be made available to speech therapists to document the feeding session and provide written recommendations in their weekly report. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to independent oral feeding | Time interval in days from introduction of oral feeding to full independent oral feeding | Birth to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postnatal age at discharge | Age in days at the time of hospital discharge | Birth to 120 days |
| Length of hospital stay | Total number of hospitalization days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A. Salas, MD, MSPH | University of Alabama at Birmingham | Principal Investigator |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Control | Diagnostic Test | In the control group, the information captured by the Instrumented Bottle will not be made available to speech therapists and therefore, will not be used to document a feeding session or provide weekly recommendations. |
|
| Birth to 120 days |
| Growth rate during the transition from tube to oral feeding | Weekly weight gain in g/kg/day | Birth to 120 days |
| Tube feeding events per day during the transition from tube to oral feeding. | Daily count of tube feeding events | Birth to 120 days |
| D000091642 | Urogenital Diseases |
| D001522 | Behavior, Animal |
| D001519 | Behavior |