Nasal Aspirators for Infant Cold Symptoms

Overseen By Valerie Cote

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Eastern Ontario

Disqualifiers: Child hospitalized, No respiratory illness, Craniofacial syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

28 Participants Needed

Trial Summary

Do I need to stop my child's current medications for this trial?

The trial protocol does not specify whether you need to stop your child's current medications. It seems focused on using nasal aspirators, so it's likely you can continue with existing medications, but please confirm with the trial coordinators.

What data supports the effectiveness of nasal aspirators for treating infant cold symptoms?

Research shows that nasal aspirators are effective in removing excess nasal secretions in babies with viral infections, helping to relieve nasal congestion. Additionally, treatments like Physiomer baby have been shown to quickly reduce inflammation and clear nasal passages, which can improve the effectiveness of other medications. ^{1 2 3 4 5}

Is the use of nasal aspirators safe for infants?

A study on the nasal aspirator Narhinel found it to be safe for treating nasal congestion in babies with viral infections of the upper respiratory tract. ^{1 2 4 6 7}

How do nasal aspirators for infant cold symptoms differ from other treatments?

Nasal aspirators are unique because they provide a non-drug, mechanical method to relieve nasal congestion in infants by physically removing mucus from the nose, unlike medications that may involve chemical ingredients or systemic effects. ^{8 9 10 11 12}

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.

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

Exclusion Criteria

Child does not have a respiratory illness

Child has a diagnosed craniofacial syndrome

Child is admitted to hospital

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the assigned nasal aspirator device at home according to the device instructions during two periods: for 10 days while their infant is sick, and for up to 3 months after.

3 months

Online surveys at 1-2 days, 4-5 days, 7-10 days, and biweekly for 3 months

Follow-up

Participants are monitored for changes in caregiver's user experience, infant's symptoms, and caregiver's habits through online surveys.

3 months

Biweekly online surveys

Treatment Details

Interventions

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

Trial Overview The 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

Group I: NozeBot Arm Experimental Treatment 1 Intervention

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

Group II: NoseFrida Arm Active Control 1 Intervention

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

Group III: hydraSense Arm Active Control 1 Intervention

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

Group IV: Braun Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Children's Hospital of Eastern Ontario

Lead Sponsor

Trials

134

Recruited

61,000+

Dr. Noze Best LLC

Collaborator

Trials

1

Recruited

30+

Findings from Research

'Momate Rhino Advance', a nasal spray combining mometasone furoate and azelastine, is effective for treating moderate to severe allergic rhinitis, allowing for better symptom control.

The treatment strategy involves starting with the combination spray and then transitioning to 'Momate Rhino' alone for 2-4 weeks, which simplifies medication regimens and reduces the need for multiple drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of modern topical medications for the stepwise treatment of allergic rhinitis: the effectiveness and prospects for the further extension of their application]. Nosulya, EV., Kim, IA.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Efficacy of a new medical device based on colloidal silver and carbossimetyl beta glucan in treatment of upper airways disease in children. [2011]

2. Italy pubmed.ncbi.nlm.nih.gov

Safety of use, efficacy and degree of parental satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. [2014]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Treatment of acute rhinitis in neonates and infants]. [2015]

4. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The use of modern topical medications for the stepwise treatment of allergic rhinitis: the effectiveness and prospects for the further extension of their application]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The efficacy and safety of an office-based polypectomy with a vacuum-powered microdebrider. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The clinicopathological spectrum of olfactory neuroblastoma and sinonasal neuroendocrine neoplasms: Refinements in diagnostic criteria and impact of multimodal treatments on survival. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Management of Locally Advanced Esthesioneuroblastoma in a Pregnant Woman. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Olfactory neuroblastoma (esthesioneuroblastoma) in a 2-year-old boy. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Low-Grade Esthesioneuroblastoma Presenting as SIADH: A Review of Atypical Manifestations. [2021]

12. India pubmed.ncbi.nlm.nih.gov

Advanced olfactory neuroblastoma treated with combined conventional and hypofractionated stereotactic radiotherapy. [2011]