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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infant Development; Infant, Very Low Birth Weight; Feeding Patterns
• Intervention / Treatment: Behavioral: Cue-based feedings

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• 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.

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Cue-based feedings	Behavioral: Cue-based feedings; Speech therapists will use cue-based protocols to guide feeds; Other Names: Speech therapy driven feeds
No Intervention: Control; Clinician based feedings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time interval in days from introduction to attainment of independent oral feeding	4-20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4-6 months after birth

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: IRB-300012540

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No