Feeding Patterns, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Premature
Conditions
Brief summary
In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants
Detailed description
In this parallel-group randomized controlled trial, ELBW infants (birthweight \< 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).
Interventions
DIAGNOSTIC_TESTReporting of sucking patterns captured by Instrumented Bottle
In the intervention group, data on nutritive sucking and feeding cues captured by the Instrumented Bottle will be made available to speech therapists to document the feeding session and provide written recommendations in their weekly report.
DIAGNOSTIC_TESTControl
In the control group, the information captured by the Instrumented Bottle will not be made available to speech therapists and therefore, will not be used to document a feeding session or provide weekly recommendations.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Days to 60 Days
Healthy volunteers
No
Inclusion criteria
* Birthweight \< 1000 grams * Gestational age \< 32 weeks of gestation * Full enteral feeding established before or on postnatal day 21 * Oral feeding initiated before or at 33 weeks of postmenstrual age
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 | Description |
|---|---|---|
| Time to independent oral feeding | Birth to 120 days | Time interval in days from introduction of oral feeding to full independent oral feeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postnatal age at discharge | Birth to 120 days | Age in days at the time of hospital discharge |
| Length of hospital stay | Birth to 120 days | Total number of hospitalization days |
| Growth rate during the transition from tube to oral feeding | Birth to 120 days | Weekly weight gain in g/kg/day |
| Tube feeding events per day during the transition from tube to oral feeding. | Birth to 120 days | Daily count of tube feeding events |
Outcome results
None listed