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

NCT ID: NCT06569186

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2028-10-31

Brief Summary

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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

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Conditions

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Infant, Very Low Birth Weight Infant Development Feeding Patterns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention and Control groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Cue-based feedings

Group Type ACTIVE_COMPARATOR

Cue-based feedings

Intervention Type BEHAVIORAL

Speech therapists will use cue-based protocols to guide feeds

Control

Clinician based feedings

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cue-based feedings

Speech therapists will use cue-based protocols to guide feeds

Intervention Type BEHAVIORAL

Other Intervention Names

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Speech therapy driven feeds

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Ariel A. Salas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300012540

Identifier Type: -

Identifier Source: org_study_id

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