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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Texas Children's Hospital
FridaBaby LLC
Information provided by (Responsible Party):
Shabana Yusuf, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT02219334
First received: August 14, 2014
Last updated: July 16, 2015
Last verified: July 2015
  Purpose
The purpose of our study is to determine the safety, efficacy, length of stay and parental satisfaction of the NoseFrida in comparison to suction devices used in the hospital setting in patients with bronchiolitis in the Emergency Department Observation Unit (EDOU).

Condition Intervention
Bronchiolitis
Device: NoseFrida

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study

Further study details as provided by 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 2016
Estimated Primary Completion Date: May 2016 (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 EDOU is a common destination of patients with bronchiolitis. Patients are admitted to the EDOU 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 EDOU 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02219334

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
FridaBaby LLC
Investigators
Principal Investigator: Elizabeth L Watson, BSN 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: Shabana Yusuf, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02219334     History of Changes
Other Study ID Numbers: H-33659
Study First Received: August 14, 2014
Last Updated: July 16, 2015

Keywords provided by 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

ClinicalTrials.gov processed this record on March 24, 2017