Trial Outcomes & Findings for Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe (NCT NCT04599101)

Results Overview

Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

5 days

Results posted on

2024-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	12	9
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal Suction Device: Nose Frida n=12 Participants 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.	Nasal Suction Device: Bulb n=9 Participants 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.	Total n=21 Participants Total of all reporting groups
Age, Continuous	11.3 months STANDARD_DEVIATION 2.5 • n=12 Participants	8.5 months STANDARD_DEVIATION 6.8 • n=9 Participants	10.1 months STANDARD_DEVIATION 4.9 • n=21 Participants
Sex: Female, Male Female	5 Participants n=12 Participants	3 Participants n=9 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=12 Participants	6 Participants n=9 Participants	13 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	9 participants n=9 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=7 Participants 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.	Nasal Suction Device: Bulb n=4 Participants 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.
Number of Emergency Room Visits	0 number of visits	0 number of visits

PRIMARY outcome

Timeframe: 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.

Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=7 Participants 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.	Nasal Suction Device: Bulb n=4 Participants 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.
Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

In response to "Which device did you prefer?" on caregiver survey, caregiver may select NoseFrida, Bulb Syringe, Both, or Neither.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Number of days after discharge until respiratory symptoms (tachypnea, retractions, increased WOB) return to pre-illness levels.

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=3 Participants 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.	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.
Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels	1.3 days Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: 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.

Number of days after discharge until eating/drinking returns to pre-illness levels

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=6 Participants 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.	Nasal Suction Device: Bulb n=4 Participants 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.
Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels	1.5 days Standard Deviation 1.2	1.0 days Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Number of days after discharge until sleeping returns to pre-illness levels

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=4 Participants 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.	Nasal Suction Device: Bulb n=3 Participants 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.
Number of Days After Discharge Until Sleeping Returns to Pre-illness Levels	1.0 days Standard Deviation 0	1.0 days Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

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?"

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=4 Participants 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.	Nasal Suction Device: Bulb n=2 Participants 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.
Parental Satisfaction on Suction Product Efficacy	4 score on a scale Interval 3.0 to 5.0	4.5 score on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 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.

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?"

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=4 Participants 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.	Nasal Suction Device: Bulb n=2 Participants 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.
Parental Satisfaction on Ease of Use	4.5 score on a scale Interval 3.0 to 5.0	4.5 score on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 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.

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."

Outcome measures

Outcome measures
Measure	Nasal Suction Device: Nose Frida n=4 Participants 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.	Nasal Suction Device: Bulb n=2 Participants 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.
Participant Recommendation to Other Parents	4.5 score on a scale Interval 4.0 to 5.0	4.5 score on a scale Interval 3.0 to 5.0

Adverse Events

Nasal Suction Device: Nose Frida

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nasal Suction Device: Bulb

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Batchelder, Research Nurse Manager

William Beaumont Hospitals

Phone: 2488981075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place