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

ConditionsInfant, Very Low Birth WeightInfant DevelopmentFeeding Patterns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-32
SponsorUniversity of Alabama at Birmingham

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Major congenital/chromosomal anomalies,

Patent ductus arteriosus causing significant cardiovascular symptoms

History of necrotizing enterocolitis stage 2 or greater

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cue-based feedings

    Behavioral

    Speech therapists will use cue-based protocols to guide feeds

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time interval in days from introduction to attainment of independent oral feeding

Time frame
4-20 days

Secondary outcomes

1

Postnatal age at discharge in days

Time frame
34 to 40 weeks postnatal age
2

Length of hospital stay in days

Time frame
10-60 days
3

Average weight gain during the transition from tube to oral feeding

Time frame
10-60 days
4

Total number of tube feeding events per infant during the transition from tube to oral feeding

Time frame
10-60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: