Nasal Aspirators for Infant Cold Symptoms

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Children's Hospital of Eastern Ontario

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for caregivers of infants with a common cold or upper respiratory infection. Participants will use and evaluate one of four nasal aspirators to relieve their infant's congestion. Caregivers must be willing to follow the study protocol, including using the device as instructed and completing online surveys.

Inclusion Criteria

Seeking outpatient care for the child for a respiratory illness (cold, flu, RSV) at the Kids Come First Care clinic

Child does not have any contraindications to the use of a nasal aspirator

Parent(s)/caregiver(s) are fluent in English

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Exclusion Criteria

Child does not have a respiratory illness

Child has a diagnosed craniofacial syndrome

Child is admitted to hospital

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Treatment Details

Interventions

Braun Nasal Aspirator (Nasal Aspirator)
hydraSense Baby Nasal Care Nasal Aspirator Starter Kit (Nasal Aspirator)
NoseFrida the SnotSucker (Nasal Aspirator)
NozeBot Electric Nasal Aspirator (Nasal Aspirator)

Trial OverviewThe trial compares caregiver experiences with four different nasal aspirators: NozeBot Electric, NoseFrida SnotSucker, hydraSense Baby Nasal Aspirator Kit, and Braun Nasal Aspirator. It assesses changes in infants' symptoms and caregivers' habits over time while using these devices.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: NozeBot ArmExperimental Treatment1 Intervention

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

Group II: NoseFrida ArmActive Control1 Intervention

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

Group III: hydraSense ArmActive Control1 Intervention

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

Group IV: Braun ArmActive Control1 Intervention

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