Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-10-31
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Reporting of sucking patterns captured by Instrumented Bottle
Weekly reporting on objective measurements of sucking activity during oral feeding
Reporting of sucking patterns captured by Instrumented Bottle
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.
Control
Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)
Control
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.
Interventions
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Reporting of sucking patterns captured by Instrumented Bottle
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.
Control
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.
Eligibility Criteria
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Inclusion Criteria
* Gestational age \< 32 weeks of gestation
* Full enteral feeding established before or on postnatal day 21
* Oral feeding initiated before or at 33 weeks of postmenstrual age
Exclusion Criteria
* Patent ductus arteriosus causing significant cardiovascular symptoms
* History of necrotizing enterocolitis stage 2 or greater
7 Days
60 Days
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Ariel A. Salas
Assistant Professor
Principal Investigators
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Ariel A. Salas, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Other Identifiers
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300004412
Identifier Type: -
Identifier Source: org_study_id
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