Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthw... | NCT06569186

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

NCT06569186

Sponsor

University of Alabama at Birmingham

Status

Not yet recruiting

Last Update Posted

Aug 15, 2025Actual

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Infant, Very Low Birth Weight
Infant Development
Feeding Patterns

Interventions

Cue-based feedings

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2026Estimated

Primary Completion Date

May 2028Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Aug 21, 2024

First Submission Date that Met QC Criteria

Aug 21, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2025

Last Update Posted Date

Aug 15, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ariel A. Salas, Principal Investigator, University of Alabama at BirminghamPrincipal Investigator

Lead Sponsor

University of Alabama at BirminghamOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Cue-based feedings	Behavioral: Cue-based feedings
Control	No Intervention	Clinician based feedings

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cue-based feedings	Behavioral	Speech therapists will use cue-based protocols to guide feeds	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Weeks

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States

Condition Browse Module

MeSH Terms

ID	Term
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided