Bronchiolitis, Respiratory Disease
Conditions
Keywords
nasal suction, nasal secretions
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 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.
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.
Interventions
DEVICENose Frida nasal suction device
Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
DEVICEBulb syringe nasal suction device
Caregivers will be given a bulb syringe device to remove the child's nasal secretions.
Sponsors
Fridababy
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single site, prospective
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Emergency Room Visits | 5 days | Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey |
| Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration | 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Perception of Bulb Device Effectiveness | 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 |
| Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels | 7 days | Number of days after discharge until respiratory symptoms (tachypnea, retractions, increased WOB) return 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 eating/drinking returns to pre-illness levels |
| Caregiver Device Preference | 5 days | In response to Which device did you prefer? on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither. |
| Parental Satisfaction on Suction Product Efficacy | 7 days | 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? |
| Parental Satisfaction on Ease of Use | 7 days | 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? |
| Participant Recommendation to Other Parents | 7 days | 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. |
| Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels | 7 days | Number of days after discharge until sleeping returns to pre-illness levels |
| Caregiver Perception of NoseFrida Device Effectiveness | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
Baseline characteristics
| Characteristic | Nasal Suction Device: Bulb | Total | Nasal Suction Device: Nose Frida |
|---|---|---|---|
| Age, Continuous | 8.5 months STANDARD_DEVIATION 6.8 | 10.1 months STANDARD_DEVIATION 4.9 | 11.3 months STANDARD_DEVIATION 2.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 21 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
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
Time frame: 5 days
Population: 5 participants in bulb group and 5 participants in the nose frida group did not complete follow up and no data was collected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nasal Suction Device: Nose Frida | Number of Emergency Room Visits | 0 number of visits |
| Nasal Suction Device: Bulb | Number of Emergency Room Visits | 0 number of visits |
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
Time frame: 5 days
Population: 5 participants in bulb group and 5 participants in the nose frida group did not complete follow up and no data was collected.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Suction Device: Nose Frida | Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration | 0 Participants |
| Nasal Suction Device: Bulb | Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration | 0 Participants |
Secondary
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
Population: This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision.
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
Time frame: 5 days
Population: This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision.
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
Time frame: 5 days
Population: This outcome measure was applicable to a protocol revision where participants received both devices. No data was collected under this protocol revision.
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
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Suction Device: Nose Frida | Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels | 1.5 days | Standard Deviation 1.2 |
| Nasal Suction Device: Bulb | Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels | 1.0 days | Standard Deviation 0 |
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Suction Device: Nose Frida | Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels | 1.3 days | Standard Deviation 0.6 |
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
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nasal Suction Device: Nose Frida | Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels | 1.0 days | Standard Deviation 0 |
| Nasal Suction Device: Bulb | Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels | 1.0 days | Standard Deviation 0 |
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?
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nasal Suction Device: Nose Frida | Parental Satisfaction on Ease of Use | 4.5 score on a scale |
| Nasal Suction Device: Bulb | Parental Satisfaction on Ease of Use | 4.5 score on a scale |
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?
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nasal Suction Device: Nose Frida | Parental Satisfaction on Suction Product Efficacy | 4 score on a scale |
| Nasal Suction Device: Bulb | Parental Satisfaction on Suction Product Efficacy | 4.5 score on a scale |
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nasal Suction Device: Nose Frida | Participant Recommendation to Other Parents | 4.5 score on a scale |
| Nasal Suction Device: Bulb | Participant Recommendation to Other Parents | 4.5 score on a scale |