Nutritive Sucking Patterns in Premature Infants

Study Overview
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Brief Summary
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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
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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).

Official Title
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Nutritive Sucking Patterns in Premature Infants: A Randomized Trial

Conditions
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Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns

Intervention / Treatment
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* Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle
* Diagnostic Test: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 60 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reporting of sucking patterns captured by Instrumented Bottle<br>Weekly reporting on objective measurements of sucking activity during oral feeding | Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle<br>* 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.<br>|
| Sham Comparator: Control<br>Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported) | Diagnostic Test: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to independent oral feeding | Time interval in days from introduction of oral feeding to full independent oral feeding | Birth to 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postnatal age at discharge | Age in days at the time of hospital discharge | Birth to 120 days | 
| Length of hospital stay | Total number of hospitalization days | Birth to 120 days | 
| Growth rate during the transition from tube to oral feeding | Weekly weight gain in g/kg/day | Birth to 120 days | 
| Tube feeding events per day during the transition from tube to oral feeding. | Daily count of tube feeding events | Birth to 120 days |