NCT04561700

Nutritive Sucking Patterns in Premature Infants

Nutritive Sucking Patterns in Premature Infants: A Randomized Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 7 Days – 60 Days
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Premature
• Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified
• Feeding Patterns

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-07-01
• Completion: 2023-06-01
• First posted: 2020-09-24
• Last updated: 2022-01-10