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

NCT06569186 | Not Yet Recruiting

• 1 other identifier: IRB-300012540
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time interval in days from introduction to attainment of independent oral feeding

  4-20 days

Secondary Outcomes (5)

• Postnatal age at discharge in days

  34 to 40 weeks postnatal age

• 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

• Follow up phone call

  4-6 months after birth

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Cue-based feedings

Behavioral: Cue-based feedings

Control

NO INTERVENTION

Clinician based feedings

Interventions

Cue-based feedings BEHAVIORAL

Speech therapists will use cue-based protocols to guide feeds

Also known as: Speech therapy driven feeds

Intervention

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Birthweight \< 1500 grams
• Gestational age between 28 and 31 weeks of gestation
• Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
• Oral feeding initiated before 33 weeks PMA.

You may not qualify if:

• Major congenital/chromosomal anomalies,
• Patent ductus arteriosus causing significant cardiovascular symptoms
• History of necrotizing enterocolitis stage 2 or greater

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention and Control groups

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

US (1)