Not Yet RecruitingNot Applicable

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

United States74 participantsStarted 2026-12

Plain-language 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.

Who can participate

Age range28 Weeks – 32 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 4-20 days

Trial details

NCT IDNCT06569186

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

View on ClinicalTrials.gov More Infant, Very Low Birth Weight trials