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

Boston Children's Hospital logo

Boston Children's Hospital

Status

Withdrawn

Conditions

Deglutition Disorders in Infants
Bottle Feeding

Treatments

Other: Three study conditions

Study type

Observational

Funder types

Other

Identifiers

NCT03892811
IRB-P00028852

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

12 hours to 3 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Infants referred for swallow study
Description:
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.
Treatment:
Other: Three study conditions

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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