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

The University of Alabama at Birmingham

Status: Not yet enrolling

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

Treatments: Behavioral: Cue-based feedings

Study type: Interventional

Funder types: Other

Identifiers

NCT06569186

IRB-300012540

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Cue-based feedings

Treatment:

Behavioral: Cue-based feedings

Control

No Intervention group

Description:

Clinician based feedings