Suctioning of NOse Therapy in Bronchiolitis

NCT03361371 | Completed FDA Device

• 1 other identifier: 1671
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 3

Brief Summary

Research Questions: Primary: In otherwise healthy infants 4 weeks to 12 months of age discharged home from the ED with acute bronchiolitis,1 is there a difference in the probability of "treatment failure" by 72 hours post discharge from the index ED visit in those receiving nasal suctioning via Zo-Li device prior to feeds compared to infants who receive nasal suctioning via bulb? Treatment failure is defined as 1) any bronchiolitis-related healthcare visit, except visits that have occurred only due to ED-recommendation at time of ED discharge or 2) the use of additional (non-study assigned) suctioning devices (see Outcome Measures section) within approximately 72 hours post discharge at the index ED visit. Hypothesis: We hypothesize that the infants who undergo scheduled nasal suctioning via ZoLi device will experience a lower treatment failure probability by approximately 72 hours post discharge from index ED visit compared to those managed by suction via a bulb. Secondary:

1. 1.In these infants, is there a difference in the mean number of medical visits for bronchiolitis (defined as #1 under primary outcome above) within 72 hours of ED discharge?
2. 2.In these infants, is there a difference in the mean number of unscheduled medical visits for bronchiolitis within 72 hours of ED discharge?
3. 3.In these infants, is there a difference in the mean number of ED visits for bronchiolitis within 72 hours of ED discharge?
4. 4.In these infants, is there a difference in the probability of a parent reporting normal/near normal feeds on approximately 72 hours discharge?
5. 5.In these infants, is there a difference in the probability of a parent reporting normal/near normal sleeping on approximately 72 hours post ED discharge?
6. 6.For the parent, is there a difference in the probability of a parent reporting their own normal/near normal sleeping on approximately 72 hours post ED discharge?
7. 7.In these infants, is there a difference in the probability of parents reporting at 72 hours post ED discharge as being "very satisfied" or "satisfied" with their ability to care for their child during the study period?

Conditions

Bronchiolitis

Keywords

Nose suctioning; Pediatric

Outcome Measures

Primary Outcomes (1)

• Treatment failure as measured by questionnaire administered on day 3

  Occurrence of any of the following by day 3 post discharge home: Hospitalization for bronchiolitis, unscheduled medical visit, physician initiated visit for bronchiolitis within 3 days post discharge from initial ED visit

  Within 3 days post ED discharge at index visit

Secondary Outcomes (6)

• Unscheduled, i.e. family-initiated return medical visit for bronchiolitis as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

• Emergency Department re-visit as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

• Feeding adequacy as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

• Participant sleeping adequacy as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

• Parental sleeping adequacy as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

Other Outcomes (1)

• Clinically important side-effects from nasal suctioning as measured by questionnaire administered on day 3

  Within 3 days post ED discharge at index visit

Study Arms (2)

Interventional group

EXPERIMENTAL

Intervention Group: in addition to receiving the aforementioned bronchiolitis discharge instructions, this group will undergo nasal suctioning prior to each feeding as needed for 72 hours post discharge home, using exclusively the Zo-Li study device (see above under study device), with saline nose drops. Families in this group will be given the Zo-Li device at no cost and instructed in the appropriate technique and importance of using this tool. We shall not reveal the identity of the study devices to the ED physicians in order to minimize contamination of the control group. The ED treating physicians will also be blinded to which device the infant had been randomized to. We shall also ask the ED treating physicians not to recommend specific suctioning devices to the study patients.

Device: Battery operated nasal aspirator

Control group

PLACEBO COMPARATOR

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. This group will be suctioned prior to feeds via bulb suction (with saline drops) which is expected to provide minimal effect, due to non-sustained negative pressures generated during bulb release. Since the benefit of nasal suction in bronchiolitis is unknown, this design is ethically reasonable. However, the use of no suction would likely meet with parental resistance and enrollment would be difficult. Families in the control group will be given the bulb device at no cost and instructed in the appropriate technique of using this tool prior to feeds.

Device: Suction bulb

Interventions

Battery operated nasal aspirator DEVICE

Suctioning prior to every feed with battery operated nasal aspirator for three days in addition to the routine standard of care.

Interventional group

Suction bulb DEVICE

Suctioning prior to every feed with bulb nasal aspirator for three days in addition to the routine standard of care.

Control group

Eligibility Criteria

• Age: 4 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• Nasal congestion as per parental report and/or the treating physician
• Must have at least one of the following: home/cellular telephone or e- mail
• Informed consent
• Parent/Caregiver speaks English/French

You may not qualify if:

• Previous diagnosis of bronchiolitis made more than 3 weeks prior to this ED visit.
• 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.
• Use of any battery operated suctioning device prior to arrival. These families may choose to continue these electrical devices which would contaminate the study groups.
• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Children's Hospital of Eastern Ontario: collaborator
• London Health Sciences Centre: collaborator
• McMaster University: collaborator

Study Sites (3)

McMaster Children's Hospital

Hamilton, Ontario, Canada

Location

London Children's Hospital

London, Ontario, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Schuh S, Coates AL, Sweeney J, Rumantir M, Eltorki M, Alqurashi W, Plint AC, Zemek R, Poonai N, Parkin PC, Soares D, Moineddin R, Finkelstein Y; Pediatric Emergency Research Canada (PERC) Network. Nasal Suctioning Therapy Among Infants With Bronchiolitis Discharged Home From the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2337810. doi: 10.1001/jamanetworkopen.2023.37810.

  PMID: 37856126 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Suzanne Schuh, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Model Details: Prospective interventional.

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 4, 2017
• Study Start: March 6, 2020
• Primary Completion: December 30, 2022
• Study Completion: January 25, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CA (3)