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

NCT03892811 | Withdrawn DMC

• 1 other identifier: IRB-P00028852
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deglutition Disorders in Infants; Bottle Feeding

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

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

Interventions

Three study conditions OTHER

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.

Infants referred for swallow study

Eligibility Criteria

• Age: 12 Hours - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Infant less than 3 months corrected age
• Must be referred for video fluoroscopic swallow study (VFSS) at Boston Children's Hospital

You may not qualify if:

• \- Infant unsafe to trial all study conditions as determined by clinician(s) conducting the VFSS.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Related 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.

  PMID: 30028734 BACKGROUND

• 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.

  PMID: 26982280 BACKGROUND

MeSH Terms

Conditions

Bottle Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Stephanie A DiPerna, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AP - Medical Staff, Radiology - Diagnostic

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: March 27, 2019
• Study Start: February 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available 2 years after study completion.
• Access Criteria: Data access requests will be reviewed by the research team.