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

• ClinicalTrials.gov Identifier: NCT04599101
• Recruitment Status: Recruiting
• First Posted: October 22, 2020
• Last Update Posted: January 24, 2022
• Sponsor: William Beaumont Hospitals
• Collaborator: Fridababy
• Information provided by (Responsible Party): Margaret J Menoch, MD, William Beaumont Hospitals

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 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.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis; Respiratory Disease	Device: Nose Frida nasal suction device; Device: Bulb syringe nasal suction device	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: single site, prospective
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
• Actual Study Start Date: November 21, 2020
• Estimated Primary Completion Date: January 6, 2023
• Estimated Study Completion Date: February 2023

Arms and Interventions

Arm	Intervention/treatment
Nasal suction devices: Nose Frida and Bulb; Nose Frida nasal suction device and bulb syringe 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.; Device: Bulb syringe nasal suction device; Caregivers will be given a bulb syringe device to remove the child's nasal secretions.

Outcome Measures

Primary Outcome Measures :

1. Number of emergency room visits [ Time Frame: 5 days ]
   Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey
2. Number of participants readmitted to Hospital for respiratory illness or dehydration [ Time Frame: 5 days ]
   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 :

1. Caregiver device preference [ Time Frame: 5 days ]
   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
2. Caregiver perception of NoseFrida device effectiveness [ Time Frame: 5 days ]
   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
3. Caregiver perception of NoseFrida Device Effectiveness [ Time Frame: 5 days ]
   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

Eligibility Criteria

• Ages Eligible for Study: up to 18 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Margaret J Menoch, MD; 248-551-5000; Margaret.Menoch@beaumont.org

Contact: Beth Kring, RN; 248-898-7289; Elizabeth.Kring@beaumont.org

Locations

United States, Michigan

Margaret J Menoch, MD; Recruiting

Royal Oak, Michigan, United States, 48073

Contact: Margaret J Menoch, MD 248-551-5000 Margaret.Menoch@beaumont.org

Contact: Beth Kring, RN 248-898-7289 ext Menoch Elizabeth.Kring@beaumont.org

Principal Investigator: Margaret J Menoch, MD

Sponsors and Collaborators

William Beaumont Hospitals

Fridababy

Investigators

• Principal Investigator: Margaret J Menoch; Beaumont

More Information

• Responsible Party: Margaret J Menoch, MD, Emergency Medicine Physician, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT04599101
• Other Study ID Numbers: 2020-325
• First Posted: October 22, 2020
• Last Update Posted: January 24, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Margaret J Menoch, MD, William Beaumont Hospitals:

nasal suction; nasal secretions

Additional relevant MeSH terms:

Bronchiolitis; Respiration Disorders; Respiratory Tract Diseases; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases