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

NCT04599101 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-04-04

Study results available
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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

Interventions

DEVICE

Nose Frida nasal suction device

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

DEVICE

Bulb syringe nasal suction device

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

Sponsors & Collaborators

  • Fridababy

    collaborator INDUSTRY

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Margaret J Menoch · Beaumont

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-21
Primary Completion
2023-04-18
Completion
2023-04-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599101 on ClinicalTrials.gov