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Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe

Primary Purpose

Bronchiolitis, Respiratory Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nose Frida nasal suction device
Bulb syringe nasal suction device
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring nasal suction, nasal secretions

Eligibility Criteria

undefined - 18 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Infants 18 months of age or younger
  • Evaluated in the Emergency Center at Beaumont, Royal Oak
  • Diagnosis of bronchiolitis, or presenting symptoms that are consistent with this diagnosis, such as cough, difficulty in breathing, wheezing, decreased oral intake, Fever
  • Initial Emergency Center visit for the current illness

Exclusion Criteria:

  • Clinically ill, as defined by: Requiring respiratory support (ex. O2 nasal canula, or HFNC) or Abnormal respiratory rate on most recent measurement, per Pediatric Advanced Life Support (PALS) guidelines: Infant- >53 breaths per minute, Toddler- >37 breaths per minute
  • Any history of structural upper airway disease, including Cleft palate, Trachemalacia/laryngomalacia or Subglottic stenosis
  • Previously enrolled in the study

Sites / Locations

  • Margaret J Menoch, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Nasal suction devices: Nose Frida and Bulb

Arm Description

Nose Frida nasal suction device and bulb syringe suction device to clear nasal secretions

Outcomes

Primary Outcome Measures

Number of emergency room visits
Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey
Number of participants readmitted to Hospital for respiratory illness or dehydration
Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey

Secondary Outcome Measures

Caregiver device preference
In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither. A higher score represents increased preference
Caregiver perception of NoseFrida device effectiveness
In response to "Which device was more effective in suctioning your baby's nose?" on caregiver survey, responses using a likert scale (0-NoseFrida less effective, 1-NoseFrida equally effective, 2-NoseFrida more effective). A higher score represents higher caregiver perceived effectiveness of NoseFrida
Caregiver perception of NoseFrida Device Effectiveness
In response to "Which device was more effective in suctioning your baby's nose?" on caregiver survey, responses using a likert scale (0-Bulb Syringe less effective, 1-Bulb Syringe equally effective, 2-Bulb Syringe more effective). A higher score represents higher caregiver perceived effectiveness of bulb syringe

Full Information

First Posted
October 17, 2020
Last Updated
June 12, 2023
Sponsor
William Beaumont Hospitals
Collaborators
Fridababy
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1. Study Identification

Unique Protocol Identification Number
NCT04599101
Brief Title
Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
Official Title
Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
Collaborators
Fridababy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research study will evaluate the difference in effectiveness of nasal suction between two different suction devices (NoseFrida and bulb syringe) in infants that have bronchiolitis. Bronchiolitis (a virus infection that goes into the lungs, which subsequently causes difficulty breathing, difficulty sleeping, and difficulty eating and drinking in children) is a common infection in young children. The caregiver-participants will be supplied with two suction devices (NoseFrida and bulb syringe suction). The devices should be used to clear nasal secretions as needed following discharge from the Emergency Center. The participants will be asked to use either a NoseFrida device or a bulb syringe first, and then to alternate thereafter. Caregivers will monitor how well their baby is breathing, eating/drinking, sleeping and how many times the baby has been seen by a medical provider in the 5 days post discharge from the Emergency Center. Post discharge, caregivers will complete a REDCAP survey asking questions about how their baby has been doing over the first 5 days following hospital discharge. This completes study involvement.
Detailed Description
Bronchiolitis is common infection in the small airways of the lungs in the pediatric population. It typically affects children under the age of two years during the fall and winter months.Infants with this condition often have a significant amount of nasal drainage and congestion. Infants are known to be obligate nasal breathers. When the nasal secretions block the nasal airway, then breathing, sleeping, and eating/drinking all become very difficult. For this reason it is very important to have a good method of suctioning out the nose and clearing out the secretions. Historically a baby's nose was suctioned with a bulb syringe. These are still commonly used and are given out in the hospital setting, although there are many other types of devices that have been developed recently that are used for suctioning. One of these devices that has become very common among parents now is called the NoseFrida. It is important to evaluate this device and its efficacy compared to the bulb syringe. This research study will evaluate the difference in effectiveness of nasal suction between two different suction devices (NoseFrida and bulb syringe) in infants that have bronchiolitis. Bronchiolitis (a virus infection that goes into the lungs, which subsequently causes difficulty breathing, difficulty sleeping, and difficulty eating and drinking in children) is a common infection in young children. Patients will be considered for enrollment in the study based on inclusion/exclusion criteria. The patient's caregiver will be supplied with an information sheet, and any questions will be addressed. Those who verbally consent will be enrolled in the study. After parents or guardians (caregivers) provide informed consent for their child, researchers will review the child's medical record for information regarding their history of respiratory distress. The caregiver will then be supplied with both suction devices to be used once they are discharged home: The participants will be asked to use either a NoseFrida device or a bulb syringe first, and then to alternate thereafter. The device supplied which is instructed to be used first will be dependent on the week of enrollment in the study (we will rotate supplying NoseFrida to all patients asking participants to use NoseFrida first one week, and bulb syringe to all patients first the next week in order to attain similar size cohorts). Education will be given on how to use their respective the suction device devices. Along with the device, a form (Home monitoring form) will be supplied that will outline what should be monitored while using the device, including: number of days after discharge until respiratory symptoms resolve, number of days until the infant is eating/drinking well, and the number of days until the infant is sleeping well. A REDCAP survey will be emailed to participants after 5 days post discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Respiratory Disease
Keywords
nasal suction, nasal secretions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single site, prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal suction devices: Nose Frida and Bulb
Arm Type
Other
Arm Description
Nose Frida nasal suction device and bulb syringe suction device to clear nasal secretions
Intervention Type
Device
Intervention Name(s)
Nose Frida nasal suction device
Intervention Description
Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
Intervention Type
Device
Intervention Name(s)
Bulb syringe nasal suction device
Intervention Description
Caregivers will be given a bulb syringe device to remove the child's nasal secretions.
Primary Outcome Measure Information:
Title
Number of emergency room visits
Description
Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey
Time Frame
5 days
Title
Number of participants readmitted to Hospital for respiratory illness or dehydration
Description
Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Caregiver device preference
Description
In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither. A higher score represents increased preference
Time Frame
5 days
Title
Caregiver perception of NoseFrida device effectiveness
Description
In response to "Which device was more effective in suctioning your baby's nose?" on caregiver survey, responses using a likert scale (0-NoseFrida less effective, 1-NoseFrida equally effective, 2-NoseFrida more effective). A higher score represents higher caregiver perceived effectiveness of NoseFrida
Time Frame
5 days
Title
Caregiver perception of NoseFrida Device Effectiveness
Description
In response to "Which device was more effective in suctioning your baby's nose?" on caregiver survey, responses using a likert scale (0-Bulb Syringe less effective, 1-Bulb Syringe equally effective, 2-Bulb Syringe more effective). A higher score represents higher caregiver perceived effectiveness of bulb syringe
Time Frame
5 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants 18 months of age or younger Evaluated in the Emergency Center at Beaumont, Royal Oak Diagnosis of bronchiolitis, or presenting symptoms that are consistent with this diagnosis, such as cough, difficulty in breathing, wheezing, decreased oral intake, Fever Initial Emergency Center visit for the current illness Exclusion Criteria: Clinically ill, as defined by: Requiring respiratory support (ex. O2 nasal canula, or HFNC) or Abnormal respiratory rate on most recent measurement, per Pediatric Advanced Life Support (PALS) guidelines: Infant- >53 breaths per minute, Toddler- >37 breaths per minute Any history of structural upper airway disease, including Cleft palate, Trachemalacia/laryngomalacia or Subglottic stenosis Previously enrolled in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret J Menoch, MD
Phone
248-551-5000
Email
Margaret.Menoch@beaumont.org
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Kring, RN
Phone
248-898-7289
Email
Elizabeth.Kring@beaumont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret J Menoch
Organizational Affiliation
Beaumont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Margaret J Menoch, MD
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret J Menoch, MD
Phone
248-551-5000
Email
Margaret.Menoch@beaumont.org
First Name & Middle Initial & Last Name & Degree
Beth Kring, RN
Phone
248-898-7289
Ext
Menoch
Email
Elizabeth.Kring@beaumont.org
First Name & Middle Initial & Last Name & Degree
Margaret J Menoch, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe

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