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Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study

This study is currently recruiting participants.
Verified July 2017 by Mary Gordon, Baylor College of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02219334
First Posted: August 18, 2014
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Mary Gordon, Baylor College of Medicine
  Purpose
The purpose of our study is to determine the safety, efficacy, length of stay and parental satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting in patients with bronchiolitis admitted under observation status.

Condition Intervention
Bronchiolitis Device: NoseFrida

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study

Further study details as provided by Mary Gordon, Baylor College of Medicine:

Primary Outcome Measures:
  • Percentage of (NoseFrida) patients discharged home before the current mean length of stay of 25.7 hours. [ Time Frame: Participants will be followed for the duration of their stay in the EDOU, an expected mean length of stay of 25.7 hours. ]
    The study group will analyze the length of stay for the NoseFrida group and compare it with the current mean length of stay (which included the use of the NeoSucker) of 25.7 hours.


Secondary Outcome Measures:
  • Number of participants with serious and non-serious adverse events [ Time Frame: Participants will be followed for the duration of their stay in the EDOU, an expected mean length of stay of 25.7 hours. ]
    The study group will be looking at the use/type of suction device and any clinically significant findings that might be caused from the suction device (NoseFrida/NeoSucker), such as bleeding.


Other Outcome Measures:
  • Percentage of patients readmitted within 48 hours of discharge. [ Time Frame: within 48 hours of discharge ]
    The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.

  • Parental satisfaction (NoseFrida group) will be measured using a newly developed survey tool (Likert scale). [ Time Frame: Participants will be followed for the duration of their stay in the EDOU, an expected mean length of stay of 25.7 hours. ]
    A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The survey is designed to capture parental satisfaction on a 5 point Likert scale.


Estimated Enrollment: 150
Study Start Date: September 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NoseFrida
If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.
Device: NoseFrida
The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.
No Intervention: NeoSucker
The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.

Detailed Description:

Bronchiolitis is a viral illness and a common cause for admission to the hospital. Most patients with bronchiolitis are managed at home. The indications of hospitalization are poor feeding (due to increased mucus production) and respiratory distress with and without hypoxia. The acute care setting is a common destination of patients with bronchiolitis. Patients are admitted to the acute care setting for respiratory monitoring, suctioning and poor oral intake. The management of bronchiolitis is mostly supportive which includes frequent feedings, nasal suctioning, intravenous fluids and oxygen if necessary. The patients admitted to the acute care setting receive frequent nasal suctioning by a suction device (NeoSucker) and deep suctioning as needed. Since young infants are "nose breathers," the use of nasal suctioning helps to relieve nasal congestion/upper airway obstruction and assists with their ability to breathe and feed. Suctioning can be accomplished by the use of the bulb suction, nasal aspirators and/or suction catheters connected to pressure devices.

The role of the type of suctioning device in the management of bronchiolitis has not been studied extensively. In our study, a nasal aspirator (developed in Sweden by an Ear, Nose and Throat specialist) by the brand name of NoseFrida will be compared to the NeoSucker, a suction catheter currently used in our hospital setting which requires both a nurse and a pressure device. Nasal suctioning is less traumatic and does not cause the discomfort, bleeding and rebound swelling that deep suctioning can. Upon admission, patients will be randomized to either the NoseFrida or NeoSucker group. After consent is obtained for agreed participation, the patients parents randomized to the NoseFrida group will be given a NoseFrida/filters and instructions on usage (instructional video/postcard). The parents will be encouraged to use the NoseFrida suction device as often as they want, especially before feeds and sleep. The patients randomized to the NeoSucker group will be given the current standard of care and nasal suctioned by a nurse. Both groups will be deep suctioned as clinically needed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients above the age of 2 months and post-gestational age to 44 weeks and less than or equal to 2 years with signs and symptoms of bronchiolitis
  • clinical respiratory score (CRS) of less than or equal to 4
  • principle diagnosis of bronchiolitis (International Classification of Diseases-9: 466, 466.11 and 466.19)

Exclusion Criteria:

  • age less than 2 months
  • age less than post-gestational age 44 weeks
  • CRS greater than 4
  • associated hypoxia
  • already using NoseFrida at home
  • chronic lung disease
  • oro-facial abnormalities
  • cardiac abnormalities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219334


Contacts
Contact: Mary Gordon, PhD 832-826-5158 mdgordon@texaschildrens.org
Contact: Elizabeth L Watson, BSN 832-824-7124 elwatson@texaschildrens.org

Locations
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Elizabeth L Watson, MSN    832-824-7124    elwatson@texaschildrens.org   
Contact: Mary Gordon, PhD    832-826-5158    mdgordon@texaschildrens.org   
Sub-Investigator: Shabana Yusuf, MD         
Sub-Investigator: Kavita Gupta, MD         
Sub-Investigator: Joseph Hagan         
Sub-Investigator: Adekunle-Ojo Aderonke, MD         
Principal Investigator: Elizabeth Watson, BSN         
Sub-Investigator: Mary Gordon, PhD         
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
Investigators
Principal Investigator: Elizabeth L Watson, BSN, RN Texas Children's Hospital
Study Director: Shabana Yusuf, MD Baylor College of Medicine
Study Chair: Aderonke Adekunle-Ojo, MD Baylor College of Medicine
  More Information

Publications:
Budhiraja, S., Verma, R., Shields, M.D. (2012). The management of acute bronchiolitis in infants. Paidiatrics and Child Health, 23(7), 296-300.

Responsible Party: Mary Gordon, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02219334     History of Changes
Other Study ID Numbers: H-33659
First Submitted: August 14, 2014
First Posted: August 18, 2014
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mary Gordon, Baylor College of Medicine:
Children
Nasal suction devices
Suctioning

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections