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

Bottle Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03892811
• Other study ID #: IRB-P00028852
• Status: Withdrawn
• Start date: February 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: June 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bottle Feeding
• Deglutition Disorders
• Deglutition Disorders in Infants

Intervention

Other:
• Three 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

References & Publications (2)

Pados BF, Park J, Dodrill P. Know the Flow: Milk Flow Rates From Bottle Nipples Used in the Hospital and After Discharge. Adv Neonatal Care. 2019 Feb;19(1):32-41. doi: 10.1097/ANC.0000000000000538. — View Citation

Pados BF, Thoyre SM, Estrem HH, Park J, Knafl GJ, Nix B. Effects of milk flow on the physiological and behavioural responses to feeding in an infant with hypoplastic left heart syndrome. Cardiol Young. 2017 Jan;27(1):139-153. doi: 10.1017/S1047951116000251. Epub 2016 Mar 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.