An interventional study of Nose Frida nasal suction device and Bulb syringe nasal suction device in Bronchiolitis and Respiratory Disease, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to participants aged Up to 18 Months. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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.
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.
360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.
This study's enrollment of 21 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nose Frida nasal suction device to clear nasal secretions
Device: Nose Frida nasal suction device
Bulb syringe suction device to clear nasal secretions
Device: Bulb syringe nasal suction device
Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
Caregivers will be given a bulb syringe device to remove the child's nasal secretions.
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
Time frame: 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
Time frame: 5 days
Caregiver Device Preference
In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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?"
Time frame: 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?"
Time frame: 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."
Time frame: 7 days
| Milestone | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Started | 12 | 9 |
| Completed | 7 | 4 |
| Not completed | 5 | 5 |
| Withdrew: Lost to follow-up | 5 | 5 |
Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey
| number of visits | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Number of Emergency Room Visits | 0 | 0 |
Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey
| Participants | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration | 0 | 0 |
In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Number of days after discharge until respiratory symptoms (tachypnea, retractions, increased WOB) return to pre-illness levels.
| days | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels | 1.3 ± 0.6 | — |
Number of days after discharge until eating/drinking returns to pre-illness levels
| days | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels | 1.5 ± 1.2 | 1.0 ± 0 |
Number of days after discharge until sleeping returns to pre-illness levels
| days | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels | 1.0 ± 0 | 1.0 ± 0 |
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?"
| score on a scale | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Parental Satisfaction on Suction Product Efficacy | 4 (3 to 5) | 4.5 (3 to 5) |
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?"
| score on a scale | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Parental Satisfaction on Ease of Use | 4.5 (3 to 5) | 4.5 (3 to 5) |
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."
| score on a scale | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb |
|---|---|---|
| Participant Recommendation to Other Parents | 4.5 (4 to 5) | 4.5 (3 to 5) |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasal Suction Device: Nose Frida | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Nasal Suction Device: Bulb | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(months) | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb | Total |
|---|---|---|---|
| Mean | 11.3 ± 2.5 | 8.5 ± 6.8 | 10.1 ± 4.9 |
| Sex: Female, Male(Participants) | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 7 | 6 | 13 |
| Race and Ethnicity Not Collected(Participants) | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Nasal Suction Device: Nose Frida | Nasal Suction Device: Bulb | Total |
|---|---|---|---|
| United States | 12 | 9 | 21 |
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William Beaumont Hospitals