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| Name | Class |
|---|---|
| Fridababy | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal suction device: Nose Frida | Experimental | Nose Frida nasal suction device to clear nasal secretions |
|
| Nasal suction device: Bulb | Active Comparator | Bulb syringe suction device to clear nasal secretions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nose Frida nasal suction device | Device | Caregivers will be given a Nose Frida device to remove the child's nasal secretions. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret J Menoch | Beaumont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Margaret J Menoch, MD | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Suction Device: Nose Frida | Nose Frida nasal suction device to clear nasal secretions Nose Frida nasal suction device: Caregivers will be given a Nose Frida device to remove the child's nasal secretions. |
| FG001 | Nasal Suction Device: Bulb | Bulb syringe suction device to clear nasal secretions Bulb syringe nasal suction device: Caregivers will be given a bulb syringe device to remove the child's nasal secretions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Suction Device: Nose Frida | Nose Frida nasal suction device to clear nasal secretions Nose Frida nasal suction device: Caregivers will be given a Nose Frida device to remove the child's nasal secretions. |
| BG001 | Nasal Suction Device: Bulb |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 participants in bulb group and 5 participants in the nose frida group did not complete follow up and no data was collected. | Posted | Number | number of visits | 5 days |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nasal Suction Device: Nose Frida | Nose Frida nasal suction device to clear nasal secretions Nose Frida nasal suction device: Caregivers will be given a Nose Frida device to remove the child's nasal secretions. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Batchelder, Research Nurse Manager | William Beaumont Hospitals | 2488981075 | christine.batchelder@corewellhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2020 | Jan 4, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2024 | Jan 4, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2023 | Jan 4, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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single site, prospective
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| Bulb syringe nasal suction device | Device | Caregivers will be given a bulb syringe device to remove the child's nasal secretions. |
|
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 |
Bulb syringe suction device to clear nasal secretions Bulb syringe nasal suction device: Caregivers will be given a bulb syringe device to remove the child's nasal secretions. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| 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 participants in bulb group and 5 participants in the nose frida group did not complete follow up and no data was collected. | Posted | Count of Participants | Participants | 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. | This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision. | Posted | 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 | This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision. | Posted | 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 | This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision. | Posted | 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. | Data was not collected for 9 participants in the bulb group who did not complete follow up. Data was not collected for 9 participants in the nose frida group who did not complete follow up. | Posted | Mean | Standard Deviation | days | 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 | No data was collected for 6 participants in the Nose Frida group who did not complete follow up. No data was collected for 5 participants in the Bulb group who did not complete follow up. | Posted | Mean | Standard Deviation | days | 7 days |
|
|
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| 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 | No data was collected for 8 participants in the Nose Frida group who did not complete follow up. No data was collected for 6 participants in the Bulb group who did not complete follow. | Posted | Mean | Standard Deviation | days | 7 days |
|
|
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| 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?" | No data collected for 8 participants in the Nose Frida group who did not complete follow up. No data collected for 7 participants in the Bulb group who did not complete follow up. | Posted | Median | Full Range | score on a scale | 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?" | No data collected for 8 participants in the Nose Frida group who did not complete follow up. No data collected for 7 participants in the Bulb group who did not complete follow up. | Posted | Median | Full Range | score on a scale | 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." | No data collected for 8 participants in the Nose Frida group who did not complete follow up. No data collected for 7 participants in the Bulb group who did not complete follow up. | Posted | Median | Full Range | score on a scale | 7 days |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Nasal Suction Device: Bulb | Bulb syringe suction device to clear nasal secretions Bulb syringe nasal suction device: Caregivers will be given a bulb syringe device to remove the child's nasal secretions. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |