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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04599101
• Other study ID #: 2020-325
• Status: Terminated
• Phase: N/A
• Start date: November 21, 2020
• Est. completion date: April 18, 2023

Study information

• Verified date: April 2024
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 18, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Device:
• Nose Frida nasal suction device
Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
• Bulb syringe nasal suction device
Caregivers will be given a bulb syringe device to remove the child's nasal secretions.

Locations

Country	Name	City	State
United States	Margaret J Menoch, MD	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Fridababy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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