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Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
NA trial testing Nose Frida nasal suction device in Bronchiolitis in 21 participants. Terminated before completion.
| Lead sponsor | Corewell Health East |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 21 November 2020 |
| Primary completion | 18 April 2023 |
| Estimated completion | 18 April 2023 |
| Sites | 1 location across United States |
Corewell Health East — full company profile →
Under 18 Months, any sex, with Bronchiolitis or Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 0 | |
| Nasal Suction Device: Bulb | 0 |
Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 0 | |
| Nasal Suction Device: Bulb | 0 |
Number of days after discharge until respiratory symptoms (tachypnea, retractions, increased WOB) return to pre-illness levels.
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 1.3 | ± 0.6 |
Number of days after discharge until eating/drinking returns to pre-illness levels
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 1.5 | ± 1.2 |
| Nasal Suction Device: Bulb | 1.0 | ± 0 |
Number of days after discharge until sleeping returns to pre-illness levels
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 1.0 | ± 0 |
| Nasal Suction Device: Bulb | 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?"
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 4 | 3 – 5 |
| Nasal Suction Device: Bulb | 4.5 | 3 – 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?"
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 4.5 | 3 – 5 |
| Nasal Suction Device: Bulb | 4.5 | 3 – 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."
| Group | Value | 95% CI |
|---|---|---|
| Nasal Suction Device: Nose Frida | 4.5 | 4 – 5 |
| Nasal Suction Device: Bulb | 4.5 | 3 – 5 |
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.
No peer-reviewed publications indexed yet for this trial.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04599101.
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