Clinical trial NCT03892811: Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants
Official title: Evaluation of the Effect of Flow Rate on Swallowing Function in Young Infants
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Deglutition Disorders in Infants
Bottle Feeding
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants less than 3 months corrected age (up to 11 weeks and 6 days) who have been referred for video fluoroscopic swallow study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VFSS - number of sucks per swallow
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - oral bolus control
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - location of swallow onset
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - presence of pharyngonasal regurgitation
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - presence of laryngeal penetration
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - presence of aspiration (silent or non-silent)
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
measure: VFSS - presence of post-swallow residue
timeFrame: Through completion of 10 swallows under each study condition, maximum of 1 minute per study condition.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Stephanie A DiPerna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.