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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06569186
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
28 Weeks - 32 Weeks
Healthy Volunteers
Accepted

Interventions

  • Cue-based feedings — BEHAVIORAL
    Speech therapists will use cue-based protocols to guide feeds

Study Details

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.

Key Dates

Start date
Dec 31, 2026
Status verified
Aug 2025
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention
    Cue-based feedings
  • No Intervention: Control
    Clinician based feedings

Primary Outcome Measure

Time interval in days from introduction to attainment of independent oral feeding [ Time Frame: 4-20 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-

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By research site
University of Alabama at Birmingham· Birmingham, AL

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