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Nasal Suction Devices for Infant Bronchiolitis
N/A
Waitlist Available
Led By Margaret J Menoch
Research Sponsored by William Beaumont Hospitals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
This trial will study whether the Nosefrida or bulb syringe is more effective in helping babies with bronchiolitis breathe better.
Who is the study for?
This trial is for infants 18 months or younger with bronchiolitis, seen at Beaumont's Emergency Center in Royal Oak. They must have symptoms like coughing, trouble breathing, wheezing, less eating/drinking, or fever. Infants needing respiratory support or with abnormal breathing rates and those with upper airway diseases can't participate.Check my eligibility
What is being tested?
The study compares two nasal suction devices: NoseFrida and bulb syringe. Caregivers will use these to clear their baby's nasal passages after leaving the hospital and track their infant’s breathing, feeding/sleeping habits, and medical visits over five days.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort or irritation in the infant’s nose from repeated suctioning with either device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Emergency Room Visits
Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration
Secondary outcome measures
Caregiver Device Preference
Caregiver Perception of Bulb Device Effectiveness
Caregiver Perception of NoseFrida Device Effectiveness
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nasal suction device: Nose FridaExperimental Treatment1 Intervention
Nose Frida nasal suction device to clear nasal secretions
Group II: Nasal suction device: BulbActive Control1 Intervention
Bulb syringe suction device to clear nasal secretions
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Who is running the clinical trial?
William Beaumont HospitalsLead Sponsor
149 Previous Clinical Trials
112,837 Total Patients Enrolled
1 Trials studying Respiratory Diseases
6 Patients Enrolled for Respiratory Diseases
FridababyUNKNOWN
1 Previous Clinical Trials
Margaret J MenochPrincipal Investigator - Beaumont
William Beaumont Hospitals
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are very sick and need help breathing, or your breathing rate is too fast according to specific guidelines for children.You have a history of structural upper airway issues like cleft palate or tracheomalacia/laryngomalacia.Babies who are 18 months old or younger.You have been diagnosed with bronchiolitis or have symptoms like coughing, trouble breathing, wheinzing, not eating much, and having a fever.
Research Study Groups:
This trial has the following groups:- Group 1: Nasal suction device: Bulb
- Group 2: Nasal suction device: Nose Frida
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrolled slots available for potential participants?
"Confirmed, this medical study is actively seeking out participants. The research was initially listed on November 21st 2020 and has since been revised as of January 20th 2022, according to the clinicaltrials.gov database."
Answered by AI
What is the total number of participants who are participating in this research?
"Affirmative. Clinicaltrials.gov exhibits that this research endeavour, which was published on November 21st 2020, is accepting participants. Approximately 100 people must be gathered from 1 centre for the study's completion."
Answered by AI
What are the ultimate objectives of this clinical research?
"This study will assess the primary outcome of Emergency Room visits over a 7-day period. It also evaluates two secondary outcomes, namely Caregiver Perception of both NoseFrida and Bulb Syringe Effectiveness on a Likert Scale (ranging from 0 to 2) as well as Number of Days until Eating/Drinking Regains Pre-Illness Levels upon Discharge."
Answered by AI
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