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

Not Applicable

Not yet recruiting

• Conditions: Infant Development; Infant, Very Low Birth Weight; Feeding Patterns

• Registration Number: NCT06569186
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Study Start: 2025-06
• Primary Completion: 2026-05
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time interval in days from introduction to attainment of independent oral feeding	4-20 days

Secondary Outcome Measures

Name	Time	Method
Follow up phone call	4-6 months after birth	A follow-up phone call 3 months after NICU discharge will also be performed to assess long-term outcomes including the need for tube feeding or hospitalizations related to feeding/nutrition problems.
Length of hospital stay in days	10-60 days
Average weight gain during the transition from tube to oral feeding	10-60 days
Total number of tube feeding events per infant during the transition from tube to oral feeding	10-60 days
Postnatal age at discharge in days	34 to 40 weeks postnatal age

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States