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
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis||Device: Battery operated nasal aspirator||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective interventional.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor is blinded to the intervention.|
|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|
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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
|Contact: Judy Sweeney, RNfirstname.lastname@example.org|
|Contact: Maggie Rumantir||416-813-7654 ext email@example.com|