Effectiveness of Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe
Phase: NA
Conditions: Bronchiolitis, Respiratory Disease
Sponsor: Corewell Health East

TITLE: 
 
Effectiveness of nasal suction in infants with bronchiolitis using a 
NoseFrida vs. bulb syringe: a prospective observational study 
 
NCT 04599101 
 
Date: 10/7/2020 
 
Study Protocol 
 

Title: Effectiveness of nasal suction in infants with bronchiolitis using a NoseFrida vs. bulb 
syringe: a prospective observational study
Abstract: 
Protocol version: 15-Sept-2020
Funding: The Fridababy company will supply 100 NoseFrida devices and replacement 
filters for use in this study. The trial design, implementation, analysis and any 
publication is entirely independent of the Fridababy company. The bulb syringe 
devices will be supplied by the Beaumont Emergency Center for those patients that 
will receive this device. 
Background/rationale: Bronchiolitis is a common infectious process during infancy, with 
reported rates of up to 30% of infants affected each year [1]. The rates have been increasing in 
the United States and it is a common cause for hospital and PICU admission [1]. These infants 
also typically present with significant rhinorrhea and congestion, which poses an issue for young 
infants and neonates, as they are obligate nasal breathers [2]. With their increased work of 
breathing and the obstructing secretions, there is often, consequently, sleeping and feeding 
difficulties [3]. Clearing the nasal secretions and providing a patent airway is recommended to 
improve these symptoms [4]. One study on patients admitted to the hospital found that long 
intervals between suctioning led to increased length of stay [5], which may suggest that frequent 
suctioning is more beneficial. Despite much anecdotal experience with the NoseFrida devise 
there is no published data comparing it to the historic standard of care, the bulb syringe. We will 
complete an observational cohort study with patients receiving either a NoseFrida or a bulb 
syringe and asses which device provides better relief to infant with bronchiolitis under 18 
months of age. 
Study design: The study will be an observational prospective cohort study, with one group 
receiving a bulb syringe and one group receiving a NoseFrida device.
Study setting: The trial will be completed at a Beaumont Children’s Emergency Center with 
recruitment beginning as soon as IRB approved..
Inclusion criteria: 

Infants 18 months of age or younger

Evaluated in the Emergency Center at Beaumont, Royal Oak for 6 months.

Diagnosis of bronchiolitis, or presenting symptoms that are consistent with this
diagnosis:
o
Cough
o
Difficulty in breathing
o
Wheezing
o
Decreased oral intake
o
Fever

Initial EC visit for the current illness
Exclusion criteria:

Clinically ill, as defined by:
o
Requiring respiratory support (ex. O2 nasal canula, or HFNC)
IRB NUMBER: 2020-325
IRB APPROVAL DATE: 10/07/2020

o
Abnormal respiratory rate on most recent measurement, per PALS
guidelines:

Infant- >53 breaths per minute

Toddler- >37 breaths per minute

Any history of structural upper airway disease, including:
o
Cleft palate
o
Tracheomalacia/laryngomalacia
o
Subglottic stenosis

Previously enrolled in the study
Intervention: Patients will be selected based on inclusion/exclusion criteria. The patient’s 
caregiver will then be supplied with an information sheet that explains the study, and any 
follow-up questions will be answered. Those who verbally consent to participate will be 
enrolled in the study. They will then receive a device to suction their infant’s nares as 
needed. The device supplied to each patient will be dependent on the week (we will 
rotate by supplying Nosefrida one week and bulb syringe the next week in order to attain 
similar size cohorts). Education will be given on how to use their respective suction 
device. Instructions on the home recoding form will be supplied to the caregiver for 
things to monitor while using the device: the average number of times the device is used 
per day, number of days after discharge until respiratory symptoms resolve, until the 
infant is eating/drinking well, until the infant is sleeping well, in addition to the number 
of provider visits during 7 days after discharge. The follOowing information will be 
recorded in Sharepoint: date  o  f presentation, MRN, age, sex, cohort group, number of 
older siblings, prior parental use of suction devices, caregiver’s email address, and phone 
number. Starting on day 7 after the discharge from the Emergency Center and then again 
day 9, a survey will be sent via RedCap .  If on day 11 the survey is not completed, a phone 
call will be made by the investigator to confirm email and then will resend if incorrect. If 
correct parent will be encouraged to complete the survey, (phone script attached).
Adherence assessment: A question on the Redcap survey will verify that the caregiver used 
only the intended method of suctioning for the infant in the 7 days post discharge 
from the Emergency Center. 
Outcomes:
Primary outcomes

Number of PCP/ER/urgent care visits for the same respiratory illness
within 7 days following discharge

Hospital admission for respiratory illness or dehydration within 7 days
following discharge
Secondary outcomes

Number of days (on a scale of days 1-7) after discharge until respiratory
symptoms (tachypnea, retractions, increased WOB) return to pre-illness
levels

Number of days (on a scale of days 1-7) after discharge until
eating/drinking returns to pre-illness levels
IRB NUMBER: 2020-325
IRB APPROVAL DATE: 10/07/2020


Number of days (on a scale of days 1-7) after discharge until sleeping
returns to pre-illness levels

Parental satisfaction on a likert scale (1-strongly disagree, 2-disagree, 3-
undecided, 4-agree, 5-strongly agree)
o
Does this product suction babies nose well?
o
Is this product easy to use?
o
Would you recommend this product to other parents?
Sample size: At the outset of our trial design, there was no data available in the literature 
regarding the use of NoseFrida as a suction device. For this reason, we are not able 
to calculate a formal sample size that would be needed to have a specified 
probability of detecting a difference with our data analysis. This study will be 
exploratory in nature. The sample size was arbitrarily chosen at 200 participants, 
100 for each cohort.
References:
1.
Øymar, K., Skjerven, H. O., & Mikalsen, I. B. (2014, April 3). Acute bronchiolitis 
in infants, a review. Retrieved from 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4230018/.
2. Trabalon, M., & Schaal, B. (2012). It takes a mouth to eat and a nose to breathe:
abnormal oral respiration affects neonates' oral competence and systemic 
adaptation. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397177/.
3. National Collaborating Centre for Women's and Children's Health (UK). (2015,
June). Supportive treatment. Retrieved from 
https://www.ncbi.nlm.nih.gov/books/NBK328408/.
4. Freeman, J. F., Weng, H.-Y. C., & Sandweiss, D. (2015, January). Outpatient
management of home oxygen for bronchiolitis. Retrieved from 
https://www.ncbi.nlm.nih.gov/pubmed/25149905.
5. Mussman, G. M., Parker, M. W., Statile, A., Sucharew, H., & Brady, P. W. (2013,
May). Suctioning and length of stay in infants hospitalized with bronchiolitis. 
Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6291830/.
IRB NUMBER: 2020-325
IRB APPROVAL DATE: 10/07/2020