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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nasal aspirators affect infants' cold symptoms and caregivers' experiences. It compares the NozeBot electric nasal aspirator with three other devices: the Braun Nasal Aspirator, hydraSense Baby Nasal Care Nasal Aspirator Starter Kit, and NoseFrida the SnotSucker. The goal is to determine which device is easiest for caregivers to use and most effective at improving infants' sleep, feeding, and breathing. Families with infants aged 2 to 18 months who visit the Kids Come First Care clinic for a respiratory illness (such as a cold or flu) and are comfortable using a nasal aspirator are invited to participate. Participants will test one device during their child's illness and in the following months, sharing their experiences through online surveys. As an unphased trial, this study allows families to contribute to research that could enhance care for infants with respiratory illnesses.

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 prior data suggests that these nasal aspirator devices are safe for infants?

Research shows that all four nasal aspirators being tested—NozeBot, NoseFrida, hydraSense, and Braun—are designed to be safe for babies.

The NozeBot electric nasal aspirator, developed by a children's ear, nose, and throat doctor, features three suction settings and uses disposable filters to maintain cleanliness and prevent germ spread. It is also free from BPA and latex, meeting important safety standards for baby products.

NoseFrida, also known as the SnotSucker, is recommended by pediatricians and contains no BPA or phthalates. Its design avoids direct insertion into the baby's nose, ensuring safety even for very young babies.

The hydraSense Baby Nasal Care Starter Kit is suitable for babies and toddlers. It uses a sterile saltwater solution without medicines or preservatives, which is gentle on little noses.

Braun's Nasal Aspirator offers two suction settings and an automatic shut-off feature for added safety. It is effective for both babies and toddlers, providing a gentle and quick way to clear stuffy noses.

All these devices prioritize safety for babies, with user-friendly features that focus on the baby's comfort and ease of use for caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these nasal aspirators for infant cold symptoms because they offer unique features compared to traditional bulb syringes and manual aspirators. The NozeBot electric nasal aspirator stands out with its electric-powered suction, providing consistent and efficient clearing of mucus, which can be more effective and less tiring for parents. The NoseFrida, known as the SnotSucker, utilizes a parent-powered suction tube, allowing for controlled and gentle mucus removal, making it a favorite for its non-invasive design. The hydraSense Baby Nasal Care Kit includes saline, which helps loosen mucus before aspiration, offering a comprehensive approach. Each device presents a different method of addressing nasal congestion, aiming to improve comfort and ease of use for both infants and parents.

What evidence suggests that these nasal aspirator devices are effective for relieving infant cold symptoms?

This trial will compare the effectiveness of different nasal aspirators for relieving infant cold symptoms. Participants in the NozeBot Arm will use the NozeBot electric nasal aspirator, known for its strong suction and hospital-level power to clear severe congestion. Those in the NoseFrida Arm will use the NoseFrida SnotSucker, designed to clear stuffy noses safely without inserting anything directly into the baby's nose. Participants in the hydraSense Arm will use the hydraSense Baby Nasal Aspirator Kit, which gently removes mucus for easier breathing. Lastly, the Braun Arm will involve the Braun electric nasal aspirator, offering different suction levels to gently clear congestion. Each device aims to quickly and effectively relieve nasal congestion in babies, improving their comfort and well-being during colds. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

'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]

Citations

1.

trialx.com

trialx.com/clinical-trials/listings/302994/comparison-of-the-user-experience-of-four-nasal-aspirators-in-infants/

Comparison of the User Experience of Four Nasal ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6001015/

The impact of nasal aspiration with an automatic device on ...

The use of an automatic nasal aspirator in children with a history of recurrent wheezing was associated with an improved respiratory health during the cold ...

3.

app.trialscreen.org

app.trialscreen.org/trials/comparison-user-experience-four-nasal-aspirators-infants-trial-nct06816875

Comparing Nasal Aspirators for Infants

Comparing Nasal Aspirators for Infants. Evaluating User Experience and Effectiveness of Nasal Aspirators for Infants with Colds.

4.

braunhealthcare.com

braunhealthcare.com/us_en/nasal_aspirator/electric-nasal-aspirator/

Electric Nasal Aspirator - Braun Healthcare US

The Braun Electric Nasal Aspirator helps to clear stuffy noses quickly & gently with two nasal tips and suction levels, making this aspirator suitable for ...

5.

amazon.com

amazon.com/Braun-BNA100US-Nasal-Aspirator/dp/B07N28G62S

Braun Electric Nasal Aspirator - Mucus Remover, Blocked ...

Helps Alleviate Sinus Congestion: A gentle and comfortable way to suction mucus from your newborn or toddlers' blocked nose. Multiple Suction Levels: Choose ...

6.

hsastore.com

hsastore.com/braun-nasal-aspirator/31980.html?srsltid=AfmBOorAaosTs8Xd7BdhxSSM26cto820bfYKj9ryACnD7Vk-adrWf3Mw

HSA Eligible Braun Nasal Aspirator

Helps to clear stuffy noses quickly and gently with two nasal tips and suction levels. Features: Suitable for infants and toddlers; Auto shut off for safety ...

7.

fsastore.com

fsastore.com/braun-nasal-aspirator/31980.html?srsltid=AfmBOoqgo595I3rOfb-tBkUcWUbQOtp6sQyoh7xDBVyVl4SwvpQq93Xj

FSA Eligible Braun Nasal Aspirator

Helps to clear stuffy noses quickly and gently with two nasal tips and suction levels. Features: Suitable for infants and toddlers; Auto shut off for safety ...

8.

babylist.com

babylist.com/gp/braun-nasal-aspirator/15390/264482

Braun Nasal Aspirator

This one helps clear noses quickly and gently with two adjustable nasal tips and suction levels (surface level or deeper into the nose canal).