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

Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. 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. The caregiver-participants will be supplied with a suction devices (either NoseFrida and bulb syringe suction). The device 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. 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. REDCAP survey will be sent day 5 and again on day 7 if not completed. This completes study involvement.

Study Overview

• Status: Terminated
• Conditions: Bronchiolitis; Respiratory Disease
• Intervention / Treatment: Device: Nose Frida nasal suction device; Device: Bulb syringe nasal suction device

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 a suction device to be used once they are discharged home. The participants will be asked to use a NoseFrida device or a bulb syringe. The device supplied which is instructed to be used will be dependent on the week of enrollment in the study. 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 and again 7 days post discharge if not completed.

The protocol was revised to supply both nasal suction devices to the participants. However, no data was collected under this revised protocol before termination.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret J Menoch, MD; Phone Number: 248-551-5000; Email: Margaret.Menoch@beaumont.org
• Study Contact Backup: Name: Christine Batchelder, RN; Phone Number: 248-898-1075; Email: christine.batchelder@corewellhealth.org

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Margaret J Menoch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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, Tracheomalacia/laryngomalacia or Subglottic stenosis
• Previously enrolled in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal suction device: Nose Frida; Nose Frida nasal suction device to clear nasal secretions	Device: Nose Frida nasal suction device; Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
Active Comparator: Nasal suction device: Bulb; Bulb syringe suction device to clear nasal secretions	Device: Bulb syringe nasal suction device; Caregivers will be given a bulb syringe device to remove the child's nasal secretions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days
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	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Device Preference	In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither.	5 days
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	5 days
Caregiver Perception of Bulb 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	5 days
Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels	Number of days after discharge until respiratory symptoms (tachypnea, retractions, increased WOB) return to pre-illness levels.	7 days
Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels	Number of days after discharge until eating/drinking returns to pre-illness levels	7 days
Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels	Number of days after discharge until sleeping returns to pre-illness levels	7 days
Parental Satisfaction on Suction Product Efficacy	Parental satisfaction on a likert scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) for the question "Does this product suction babies nose well?"	7 days
Parental Satisfaction on Ease of Use	Parental satisfaction on a likert scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) for the question "Is this product easy to use?"	7 days
Participant Recommendation to Other Parents	Parental agreement on a likert scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) for the statement "I would recommend this product to other parents."	7 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Collaborators: Fridababy
• Investigators: Principal Investigator: Margaret J Menoch, Beaumont

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2020
• Primary Completion (Actual): April 18, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: October 17, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: nasal suction; nasal secretions
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2020-325

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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