Nasal Suction in Infants With Bronchiolitis Using a NoseFrida vs. Bulb Syringe

NCT04599101 | Terminated Results FDA Device

• 1 other identifier: 2020-325
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will evaluate the difference in effectiveness of nasal suction between two different suction devices (NoseFrida and bulb syringe) in infants that have bronchiolitis. Bronchiolitis (a virus infection that goes into the lungs, which subsequently causes difficulty breathing, difficulty sleeping, and difficulty eating and drinking in children) is a common infection in young children. The caregiver-participants will be supplied with a suction devices (either NoseFrida and bulb syringe suction). The device should be used to clear nasal secretions as needed following discharge from the Emergency Center. The participants will be asked to use either a NoseFrida device or a bulb syringe. Caregivers will monitor how well their baby is breathing, eating/drinking, sleeping and how many times the baby has been seen by a medical provider in the 5 days post discharge from the Emergency Center. Post discharge, caregivers will complete a REDCAP survey asking questions about how their baby has been doing over the first 5 days following hospital discharge. REDCAP survey will be sent day 5 and again on day 7 if not completed. This completes study involvement.

Conditions

Bronchiolitis; Respiratory Disease

Keywords

nasal suction; nasal secretions

Outcome Measures

Primary Outcomes (2)

• Number of Emergency Room Visits

  Number of emergency room visits for the same respiratory illness within 5 days following discharge, measured via caregiver response on Redcap survey

  5 days

• Number of Participants Readmitted to Hospital for Respiratory Illness or Dehydration

  Number of participants readmitted to Hospital for respiratory illness or dehydration within 5 days following discharge, measured via caregiver response on Redcap survey

  5 days

Secondary Outcomes (9)

• Caregiver Device Preference

  5 days

• Caregiver Perception of NoseFrida Device Effectiveness

  5 days

• Caregiver Perception of Bulb Device Effectiveness

  5 days

• Number of Days After Discharge Until Respiratory Symptoms Return to Pre-illness Levels

  7 days

• Number of Days After Discharge Until Eating/Drinking Returns to Pre-illness Levels

  7 days

Study Arms (2)

Nasal suction device: Nose Frida

EXPERIMENTAL

Nose Frida nasal suction device to clear nasal secretions

Device: Nose Frida nasal suction device

Nasal suction device: Bulb

ACTIVE COMPARATOR

Bulb syringe suction device to clear nasal secretions

Device: Bulb syringe nasal suction device

Interventions

Nose Frida nasal suction device DEVICE

Caregivers will be given a Nose Frida device to remove the child's nasal secretions.

Nasal suction device: Nose Frida

Bulb syringe nasal suction device DEVICE

Caregivers will be given a bulb syringe device to remove the child's nasal secretions.

Nasal suction device: Bulb

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants 18 months of age or younger
• Evaluated in the Emergency Center at Beaumont, Royal Oak
• Diagnosis of bronchiolitis, or presenting symptoms that are consistent with this diagnosis, such as cough, difficulty in breathing, wheezing, decreased oral intake, Fever
• Initial Emergency Center visit for the current illness

You may not qualify if:

• Clinically ill, as defined by: Requiring respiratory support (ex. O2 nasal canula, or HFNC) or Abnormal respiratory rate on most recent measurement, per Pediatric Advanced Life Support (PALS) guidelines: Infant- \>53 breaths per minute, Toddler- \>37 breaths per minute
• Any history of structural upper airway disease, including Cleft palate, Tracheomalacia/laryngomalacia or Subglottic stenosis
• Previously enrolled in the study

Sponsors & Collaborators

• Corewell Health East: lead
• Fridababy: collaborator

Study Sites (1)

Margaret J Menoch, MD

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Bronchiolitis; Respiration Disorders

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Christine Batchelder, Research Nurse Manager
• Organization: William Beaumont Hospitals

christine.batchelder@corewellhealth.org

2488981075

Study Officials

• Margaret J Menoch

  Beaumont

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Physician

Model Details: single site, prospective

Study Record Dates

• First Submitted: October 17, 2020
• First Posted: October 22, 2020
• Study Start: November 21, 2020
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)