Comparison of the User Experience of Four Nasal Aspirators in Infants

Children's Hospital of Eastern Ontario

Status: Enrolling

Conditions: Upper Respiratory Tract Infection

Treatments: Device: NozeBot Electric Nasal Aspirator; Device: hydraSense Baby Nasal Care Nasal Aspirator Starter Kit; Device: NoseFrida the SnotSucker; Device: Braun Nasal Aspirator

Study type: Interventional

Funder types: Other

Identifiers

NCT06816875

CHEO REB# 25/07X

Details and patient eligibility

About

The goal of this clinical trial is to compare the caregiver's user experience, and overall impacts on an infant's cold symptoms between four nasal aspirator devices. These devices are normally used to relieve congestion in infants. when they are sick by softening and suctioning mucus from the nose.

The main questions it aims to answer are:

What is the caregiver's user experience of the NozeBot electric nasal aspirator compared to three commonly accessible nasal aspirator devices?

Are there changes in the infant's sleeping, feeding, or breathing as reported by the caregiver when using the NozeBot compared to the three other nasal aspirator devices?

Are there changes in their caregiver's habits when using the NozeBot compared to the three other nasal aspirator devices?

Researchers will compare the self-reported measures of caregiver's user experience, reported changes to their infant's symptoms, and reported changes to their own sleeping and care habits between the NozeBot electric nasal aspirator and three comparator devices: the NoseFrida SnotSucker, the hydraSense Baby Nasal Aspirator Kit, and the Braun electric nasal aspirator.

Participants will be assigned to receive one of the four devices at the start of their participation. They will be asked to use the assigned device at home according to the device instructions during two periods: (1) for 10 days while their infant is sick, and (2) for up to 3 months after.

During these periods, participants will be asked to complete online surveys at predetermined intervals to report the user experience, any changes to their infant's sleeping, feeding or breathing, and any changes to their own sleeping habits and perceived stress levels. These intervals for survey completion are: (i) after 1-2 days of use while their infant is sick, (ii) after 4-5 days of use while their infant is sick, (iii) after 7-10 days of use while their infant is sick, and then (iv) biweekly for 3 months.

Enrollment: 28 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

A parent(s)/caregiver(s)/family will be eligible to participate if:

• They have a child between 2 months - 18 months of age
• They are seeking outpatient care for that child for a respiratory illness (cold, flu, RSV) at the Kids Come First Care clinic
• The child does not have any contraindications to the use of a nasal aspirator
• The parent(s)/caregiver(s) are fluent in English

Exclusion Criteria

A parent(s)/caregiver(s)/family will be ineligible to participate if:

• They have a child younger than 2 months or 13 months old or older currently seeking outpatient care for a respiratory illness
• The child is admitted to hospital
• The child does not have a respiratory illness
• The child has a diagnosed craniofacial syndrome
• The child has a defined contraindication and cannot use a nasal aspirator
• The parents/caregivers are not comfortable using a nasal aspirator
• The parent/caregivers are not fluent in English

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 4 patient groups

NozeBot Arm

Experimental group

Description:

Participants assigned to this group will receive the NozeBot electric nasal aspirator device.

Treatment:

Device: NozeBot Electric Nasal Aspirator

NoseFrida Arm

Active Comparator group

Description:

Participants assigned to this group will receive NoseFrida the SnotSucker product.

Treatment:

Device: NoseFrida the SnotSucker

hydraSense Arm

Active Comparator group

Description:

Participants assigned to this group will receive the hydraSense Baby Nasal Aspirator Starter Kit.

Treatment:

Device: hydraSense Baby Nasal Care Nasal Aspirator Starter Kit

Braun Arm

Active Comparator group

Description:

Participants assigned to this group will receive the Braun nasal aspirator device.

Treatment:

Device: Braun Nasal Aspirator