Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of nipple flow rate on swallowing function in infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for videofluoroscopic swallow study.

Detailed Description
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Feeding difficulties are common in infants born premature and with medical complexity, particularly those with congenital heart disease. One of the most common strategies for managing feeding difficulties is changing the milk flow rate of the bottle nipple. Milk flow is the rate at which milk transfers from the bottle to the infant's mouth. During swallowing, the vocal folds must close to prevent aspiration of fluid into the airway. When milk flow is fast, the infant must swallow frequently to clear the bolus of fluid and prevent aspiration; this is done at the expense of respiration. When the milk flow rate is slowed, the infant can swallow less frequently, allowing better integration of respiration, and has more time to coordinate an effective swallow. While there is some very limited evidence that slower milk flow rate improves feeding in infants born premature and with congenital heart disease, the underlying mechanisms for improvement of feeding remain unknown. This project will be the first to evaluate the effect of milk flow rate on swallowing function under fluoroscopy to better understanding how swallowing changes under different conditions of flow in young infants. This research will provide the evidence needed to support the use of this simple intervention (i.e., changing the flow rate) in infants at risk for feeding difficulty and swallowing dysfunction.

Official Title
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Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants

Conditions
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Deglutition Disorders in Infants, Bottle Feeding

Intervention / Treatment
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* Other: Three study conditions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant less than 3 months corrected age Must be referred for video fluoroscopic swallow study (VFSS) at Boston Children's Hospital Exclusion Criteria: - Infant unsafe to trial all study conditions as determined by clinician(s) conducting the VFSS.

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants referred for swallow study<br>This is a within-subjects intervention study where each infant in the study will receive all three conditions. The three study conditions are bottle-feeding with 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple. | Other: Three study conditions<br>* Continuous fluoroscopy (at 30 frames/second) will be used for intermittent periods to capture 10 swallows in the initial sucking sequence of each of three study conditions: 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VFSS - number of sucks per swallow | Number of sucks per swallow for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - oral bolus control | Oral bolus control for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - location of swallow onset | Location of swallow onset for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - presence of pharyngonasal regurgitation | Presence of pharyngonasal regurgitation for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - presence of laryngeal penetration | Presence of laryngeal penetration for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - presence of aspiration (silent or non-silent) | Presence of aspiration (silent or non-silent) for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. | 
| VFSS - presence of post-swallow residue | Presence of post-swallow residue for each of 10 swallows under each of the three study conditions. | Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition. |