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

NCT ID: NCT04599101

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-21
• Study Completion Date: 2023-04-18

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.

Detailed Description

Bronchiolitis is common infection in the small airways of the lungs in the pediatric population. It typically affects children under the age of two years during the fall and winter months.Infants with this condition often have a significant amount of nasal drainage and congestion. Infants are known to be obligate nasal breathers. When the nasal secretions block the nasal airway, then breathing, sleeping, and eating/drinking all become very difficult. For this reason it is very important to have a good method of suctioning out the nose and clearing out the secretions. Historically a baby's nose was suctioned with a bulb syringe. These are still commonly used and are given out in the hospital setting, although there are many other types of devices that have been developed recently that are used for suctioning. One of these devices that has become very common among parents now is called the NoseFrida. It is important to evaluate this device and its efficacy compared to the bulb syringe.

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. Patients will be considered for enrollment in the study based on inclusion/exclusion criteria. The patient's caregiver will be supplied with an information sheet, and any questions will be addressed. Those who verbally consent will be enrolled in the study. After parents or guardians (caregivers) provide informed consent for their child, researchers will review the child's medical record for information regarding their history of respiratory distress. The caregiver will then be supplied with a suction device to be used once they are discharged home. The participants will be asked to use a NoseFrida device or a bulb syringe. The device supplied which is instructed to be used will be dependent on the week of enrollment in the study. Education will be given on how to use their respective the suction device devices. Along with the device, a form (Home monitoring form) will be supplied that will outline what should be monitored while using the device, including: number of days after discharge until respiratory symptoms resolve, number of days until the infant is eating/drinking well, and the number of days until the infant is sleeping well. A REDCAP survey will be emailed to participants after 5 days post discharge and again 7 days post discharge if not completed.

The protocol was revised to supply both nasal suction devices to the participants. However, no data was collected under this revised protocol before termination.

Conditions

Bronchiolitis; Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nasal suction device: Nose Frida

Nose Frida nasal suction device to clear nasal secretions

Group Type: EXPERIMENTAL

Nose Frida nasal suction device

Intervention Type: DEVICE

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

Nasal suction device: Bulb

Bulb syringe suction device to clear nasal secretions

Group Type: ACTIVE_COMPARATOR

Bulb syringe nasal suction device

Intervention Type: DEVICE

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

Interventions

Nose Frida nasal suction device

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

Intervention Type: DEVICE

Bulb syringe nasal suction device

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fridababy

INDUSTRY

Sponsor Role: collaborator

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Margaret J Menoch, MD

Emergency Medicine Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret J Menoch

Role: PRINCIPAL_INVESTIGATOR

Beaumont

Locations

Margaret J Menoch, MD

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2020-325

Identifier Type: -

Identifier Source: org_study_id