Feeding Patterns, Infant Development, Infant, Very Low Birth Weight
Conditions
Brief 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.
Interventions
BEHAVIORALCue-based feedings
Speech therapists will use cue-based protocols to guide feeds
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intervention and Control groups
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time interval in days from introduction to attainment of independent oral feeding | 4-20 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postnatal age at discharge in days | 34 to 40 weeks postnatal age | — |
| Length of hospital stay in days | 10-60 days | — |
| Average weight gain during the transition from tube to oral feeding | 10-60 days | — |
| Total number of tube feeding events per infant during the transition from tube to oral feeding | 10-60 days | — |
| Follow up phone call | 4-6 months after birth | A follow-up phone call 3 months after NICU discharge will also be performed to assess long-term outcomes including the need for tube feeding or hospitalizations related to feeding/nutrition problems. |
Countries
United States
Outcome results
None listed