Skip to content

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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03892811
Enrollment
0
Registered
2019-03-27
Start date
2018-02-01
Completion date
2019-01-30
Last updated
2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bottle Feeding, Deglutition Disorders in Infants

Brief summary

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

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.

Interventions

OTHERThree study conditions

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.

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Hours to 3 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
VFSS - number of sucks per swallowThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Number of sucks per swallow for each of 10 swallows under each of the three study conditions.
VFSS - oral bolus controlThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Oral bolus control for each of 10 swallows under each of the three study conditions.
VFSS - location of swallow onsetThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Location of swallow onset for each of 10 swallows under each of the three study conditions.
VFSS - presence of pharyngonasal regurgitationThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Presence of pharyngonasal regurgitation for each of 10 swallows under each of the three study conditions.
VFSS - presence of laryngeal penetrationThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Presence of laryngeal penetration for each of 10 swallows under each of the three study conditions.
VFSS - presence of aspiration (silent or non-silent)Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Presence of aspiration (silent or non-silent) for each of 10 swallows under each of the three study conditions.
VFSS - presence of post-swallow residueThrough completion of 10 swallows under each study condition, maximum of 1 minute per study condition.Presence of post-swallow residue for each of 10 swallows under each of the three study conditions.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026