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

June 9, 2021 updated by: Stephanie DiPerna, Boston Children's Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 hours to 3 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants referred for swallow study

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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Stephanie A DiPerna, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2018

Primary Completion (ACTUAL)

January 30, 2019

Study Completion (ACTUAL)

January 30, 2019

Study Registration Dates

First Submitted

February 6, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (ACTUAL)

March 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00028852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data will be made available in a secure Database.

IPD Sharing Time Frame

Data will be made available 2 years after study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by the research team.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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