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Suctioning of NOse Therapy Versus Usual Home Care in Bronchiolitis (SNOT)

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ClinicalTrials.gov Identifier: NCT03361371
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Children's Hospital of Eastern Ontario
London Health Sciences Centre
Information provided by (Responsible Party):
Suzanne Schuh, The Hospital for Sick Children

Brief Summary:
The sample size calculation is based on the assessment of the between-group difference in probability of treatment failure. The estimated total re-visit probability in bronchiolitis based on a recently published study was approximately 35% within 72 hours of ED discharge.50 The investigators can therefore reasonably assume this proportion may approach 50% by day 7. Using the 50% estimate is conservative since it requires the largest sample size, providing at least 80% power regardless of the observed proportions. This is a superiority study in which the adoption of nasal suctioning will be recommended for future practice if the observed proportion of the primary outcome in this group is significantly lower than in the controls. With 186 patients per arm (372 in total) a two-sided test with a type I error of 0.05 will have 80% power to achieve statistical significance if suctioning reduces the probability of treatment failure from 50% to 35% (i.e. absolute reduction of 15%). This estimate is based on clinically relevant differences agreed upon by study investigators and it also represents an NNT of 7. In the Cochrane review of asthma therapies an NNT of a comparable magnitude led to a change in national practice recommendations.52 Since bronchiolitis and related medical visits are highly prevalent,20 this target difference would also have an important economic impact. Based on our previous bronchiolitis trials, the anticipated refusal rate may be 20%. Given the study design and our past experience, the study non-completion rate and loss to follow-up can safely be assumed to be no higher than 5% each. Therefore, to have complete data on 372 patients the investigators plan to randomize 412 (i.e. 372/(1 - 0.05)*(1 - 0.05) and to approach 515 (i.e. 412/(1 - 0.20).

Condition or disease Intervention/treatment Phase
Bronchiolitis Device: Battery operated nasal aspirator Not Applicable

Detailed Description:

This is a three-center, randomized, outcome assessor- blinded clinical trial of infants discharged home from the ED with acute bronchiolitis. Two groups will be compared: infants receiving usual bronchiolitis care (see below) during the 7 days post ED discharge versus those given usual care plus enhanced nasal suctioning via a standardized nasal aspiration ZoLi device just prior to each feeding for 7 days post index ED visit discharge. Evidence suggests that suctioning at frequent intervals is associated with movement of secretions from the lower airway with improved minute volume. The 7- day study period has been chosen since the vast majority of infants discharged from the ED with bronchiolitis experience the targeted outcomes within this time frame.

Prior to the ED discharge, all study participants will receive usual bronchiolitis care ordered by the ED physician as per standard of care which consists of supplemental oxygen for saturations less than 90% and supplemental IV hydration in those with inadequate oral intake. Eligible consenting patients deemed suitable for discharge home (representing approximately 60-70% of the bronchiolitis population presenting to the ED) will be randomly allocated to one of two study groups:

Control Group: this group will receive standardized routine discharge instructions describing information about bronchiolitis, expected course of illness, recommended management strategies such as fever control, augmented air humidification, need for frequent feeding and warning signs prompting return for care. Some ED treating physicians also recommend removal of nasal secretions via dropper attached to a bulb (usual strategy which produces negligible negative pressures) or via other commercially available aspirators (used less commonly) - this decision will be left up to the treating ED physician and the use of such devices will be tracked. This study design is in keeping with the pragmatic nature of the study used to show the real-world differences of the intervention. The clinical experience of the investigators suggests that the ZoLi device is currently not commonly used. Furthermore, the investigators will not reveal the identity of the experimental device to the ED physicians in order to minimize contamination of the control group.

Experimental Group: in addition to the aforementioned usual bronchiolitis care at home, this group will undergo nasal suctioning prior to each feeding as needed for 7 days post discharge home (unless symptoms completely abate earlier), using exclusively the ZoLi study device (see above under study device). Families in this group will be given the ZoLi device at no cost and instructed in the appropriate technique and importance of using this tool. This explanation may enhance parental motivation to use the device.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective interventional.
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor is blinded to the intervention.
Primary Purpose: Treatment
Official Title: Suctioning of NOse Therapy Versus Usual Home Care in Bronchiolitis - a Randomized Clinical Trial
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: Interventional group
All participants will receive standard of care treatment for bronchiolitis in the ED. Participants in this group will go home with standard discharge instructions and in addition they will receive a battery operated nasal aspirator and the caregiver will be instructed and trained to suction prior to each feed for one week at home.
Device: Battery operated nasal aspirator
Battery operated nasal aspirator will be used prior to every feed for one week in addition to the routine standard of care.

No Intervention: Control group
Participants in this group will receive the bronchiolitis standard of care treatment in the ED and will go home with standard discharge instructions.



Primary Outcome Measures :
  1. Treatment failure as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Occurrence of any of the following by day 7 post discharge home: Hospitalization for bronchiolitis, unscheduled medical visit, physician initiated visit for bronchiolitis within 7 days post discharge from initial ED visit


Secondary Outcome Measures :
  1. Unscheduled, i.e. family-initiated return medical visit for bronchiolitis as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Family-initiated bronchiolitis-related medical visit

  2. Emergency Department re-visit as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    ED visits for ongoing/worsening bronchiolitis symptoms

  3. Feeding adequacy as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Normal/near normal feeding

  4. Participant sleeping adequacy as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Normal/near normal sleeping pattern

  5. Parental sleeping adequacy as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Normal/near normal sleeping pattern

  6. Parental ability to care for their sick child as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Parental level of satisfaction for their ability to care for their child's illness


Other Outcome Measures:
  1. Clinically important side-effects from nasal suctioning as measured by questionnaire administered on day 7 [ Time Frame: Within 7 days post ED discharge at index visit ]
    Side-effects with the use of any suctioning device will be tracked



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of bronchiolitis in the ED as per the AAP diagnosis definition. Bronchiolitis is defined as the first episode of viral upper respiratory infection with respiratory distress and/or tachypnea for age.
  2. Age 4 weeks up to and including 12 months of age. Participating infants will have to be at least 4 weeks post their expected due date of birth since infants with bronchiolitis below this age cut-off are at a much higher risk of apnea and dehydration than their older counterparts.
  3. Below usual feeding intake in the past 24 hours. This will be screened by the study nurse/research assistant who will ask the caregiver(s) the following questions: Compared to usual, how has your infant fed in the last 24 hours?

    1. Definitely less than normal but more than half usual intake or some difficulty breastfeeding.
    2. Very much less than normal (less than half usual intake or major difficulty breastfeeding.
  4. Informed consent

Exclusion Criteria:

  1. Previous diagnosis of bronchiolitis made more than 3 weeks prior to this ED visit.
  2. Hospitalization at the index ED visit. Although we have considered starting the experimental intervention at presentation to the ED, this was deemed counterproductive since many patients with bronchiolitis are currently routinely suctioned in the ED which would likely contaminate the control arm and impact study results.
  3. Normal/near normal feeding in the past 24 hours. The feeding adequacy will be screened by the study nurse who will ask the caregiver(s) the following questions:

    Compared to usual, how has your infant fed in the last 24 hours? Normal/ almost normal [more than about 80% usual intake]

  4. Zo-Li battery operated nasal aspirator used at home.
  5. Co-morbidities which may impact outcomes such as known diagnosis of congenital heart disease, chronic respiratory disease including known lung disease due to prematurity, aspiration due to severe gastro-esophageal reflux, neuro-muscular/neurologic disease, immunodeficiency, coagulopathies, nasal/upper airway abnormalities, oral, gastrointestinal anomalies [except for corrected pyloric stenosis], tracheo-esophageal fistulas, gastric/gastro-jejunal tube feeding supplementation.
  6. Parental poor command of the English/French language.
  7. Must have at least one of the following: home/cellular telephone or e- mail

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): NCT03361371


Contacts
Contact: Judy Sweeney, RN 416-813-7838 judy.sweeney@sickkids.ca
Contact: Maggie Rumantir 416-813-7654 ext 309153 maggie.rumantir@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Children's Hospital of Eastern Ontario
London Health Sciences Centre

Responsible Party: Suzanne Schuh, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03361371     History of Changes
Other Study ID Numbers: 1000059068
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Suzanne Schuh, The Hospital for Sick Children:
Nose suctioning
Pediatric

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