BronchiolitisNCT04599101
Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
A study testing Nose Frida nasal suction device and Bulb syringe nasal suction device in people with Bronchiolitis and Respiratory Disease, run by Corewell Health East at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Bronchiolitis, Respiratory Disease
- What is being tested?
- Nose Frida nasal suction device and Bulb syringe nasal suction device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2020to 18 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. 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. 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.
Read the 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.
- Conditions
- Bronchiolitis, Respiratory Disease
- Being tested
- Nose Frida nasal suction device, Bulb syringe nasal suction device
- Keywords
- nasal suction, nasal secretions
- Medical subject headings
- Bronchiolitis, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nose Frida nasal suction deviceDevice
Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
Bulb syringe nasal suction deviceDevice
Caregivers will be given a bulb syringe device to remove the child's nasal secretions.
| Study group | Role | What they receive |
|---|---|---|
| Nasal suction device: Nose Frida | Experimental | Nose Frida nasal suction device to clear nasal secretions Receives: Device: Nose Frida nasal suction device |
| Nasal suction device: Bulb | Active comparator | Bulb syringe suction device to clear nasal secretions Receives: Device: Bulb syringe nasal suction device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 days
Secondary outcomes (9)
Caregiver Device Preference
In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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?"
Measured: 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?"
Measured: 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."
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Nov 2020
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Why it stopped: Due to difficulty enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- single site, prospective
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Fridababy
- Responsible party
- Principal investigator, Margaret J Menoch, MD, Corewell Health East
- Investigators
- Margaret J Menoch, Principal investigator, Beaumont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599101
- Sponsor's protocol ID
- 2020-325
- Status last verified
- Apr 2024
- First submitted
- 17 Oct 2020
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
- ClinicalTrials.gov ID
- NCT04599101
- Acronym / sponsor ID
- 2020-325
- Conditions
- Bronchiolitis, Respiratory Disease
- Keywords
- nasal suction, nasal secretions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty enrolling
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Fridababy
- Study start
- 21 Nov 2020 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single site, prospective
| Arm | Type | Receives |
|---|---|---|
| Nasal suction device: Nose Frida | Experimental | Device: Nose Frida nasal suction deviceNose Frida nasal suction device to clear nasal secretions |
| Nasal suction device: Bulb | Active comparator | Device: Bulb syringe nasal suction deviceBulb syringe suction device to clear nasal secretions |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nose Frida nasal suction deviceCaregivers will be given a Nose Frida device to remove the child's nasal secretions. | Device | Nasal suction device: Nose Frida |
| Bulb syringe nasal suction deviceCaregivers will be given a bulb syringe device to remove the child's nasal secretions. | Device | Nasal suction device: Bulb |
Primary outcome
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
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
9 secondary outcomes
Caregiver Device Preference
Time frame: 5 days
Caregiver Perception of NoseFrida Device Effectiveness
Time frame: 5 days
Caregiver Perception of Bulb Device Effectiveness
Time frame: 5 days
Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels
Time frame: 7 days
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
Time frame: 7 days
Parental Satisfaction on Suction Product Efficacy
Time frame: 7 days
Parental Satisfaction on Ease of Use
Time frame: 7 days
Participant Recommendation to Other Parents
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret J Menoch principal investigator
Beaumont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nose Frida nasal suction device and Bulb syringe nasal suction device in people with Bronchiolitis and Respiratory Disease, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Emergency Room Visits (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.