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NCT06569186
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
Conditions: Infant, Very Low Birth Weight, Infant Development, Feeding Patterns
Sex: All
Ages: 28 Weeks – 32 Weeks
Healthy volunteers: Yes
Phase: NA
Sponsor: University of Alabama at Birmingham
Location: University of Alabama at Birmingham Birmingham Alabama
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.
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
Source: ClinicalTrials.gov (NCT06569186). StuddyBuddy aggregates publicly available trial information.