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

August 25, 2026 updated by: Ariel A. Salas, University of Alabama at Birmingham

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

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 4-20 days
4-20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postnatal age at discharge in days
Time Frame: 34 to 40 weeks postnatal age
34 to 40 weeks postnatal age
Length of hospital stay in days
Time Frame: 10-60 days
10-60 days
Average weight gain during the transition from tube to oral feeding
Time Frame: 10-60 days
10-60 days
Total number of tube feeding events per infant during the transition from tube to oral feeding
Time Frame: 10-60 days
10-60 days
Follow up phone call
Time Frame: 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.
4-6 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

August 27, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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