An interventional study of Reporting of sucking patterns captured by Instrumented Bottle and Control in Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified and Feeding Patterns, sponsored by University of Alabama at Birmingham. Withdrawn. Open to participants aged 7 Days to 60 Days. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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).
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
Browse Premature Birth studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
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Exclusion Criteria:
Weekly reporting on objective measurements of sucking activity during oral feeding
Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle
Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)
Diagnostic Test: Control
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.
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.
Time to independent oral feeding
Time interval in days from introduction of oral feeding to full independent oral feeding
Time frame: Birth to 120 days
Postnatal age at discharge
Age in days at the time of hospital discharge
Time frame: Birth to 120 days
Length of hospital stay
Total number of hospitalization days
Time frame: Birth to 120 days
Growth rate during the transition from tube to oral feeding
Weekly weight gain in g/kg/day
Time frame: Birth to 120 days
Tube feeding events per day during the transition from tube to oral feeding.
Daily count of tube feeding events
Time frame: Birth to 120 days
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →