Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cue-based feedings.
- Who it may be relevant to
- Registry conditions: Infant, Very Low Birth Weight, Infant Development, Feeding Patterns. Basic parameters: 28 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial
Overview
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.
Interventions
- Behavioral Cue-based feedings
Speech therapists will use cue-based protocols to guide feeds
Primary outcome measures
- Time interval in days from introduction to attainment of independent oral feeding [Time frame: 4-20 days]
Secondary outcome measures (5)
- Postnatal age at discharge in days [Time frame: 34 to 40 weeks postnatal age]
- Length of hospital stay in days [Time frame: 10-60 days]
- Average weight gain during the transition from tube to oral feeding [Time frame: 10-60 days]
- Total number of tube feeding events per infant during the transition from tube to oral feeding [Time frame: 10-60 days]
- Follow up phone call [Time frame: 4-6 months after birth]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06569186 · IRB-300012540