NCT06569186

Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants

Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Accepted

Summary

In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.

Conditions

• Infant, Very Low Birth Weight
• Infant Development
• Feeding Patterns

Interventions

Type	Name	Description
BEHAVIORAL	Cue-based feedings	Speech therapists will use cue-based protocols to guide feeds

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-05-01
• Completion: 2028-10-01
• First posted: 2024-08-23
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States