Bronchiolitis
Conditions
Brief summary
Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and IV fluids, whereas other supportive therapies such as inhalations are of questionable benefit. Moderate to severe cases are a source of distress to patient, parents and medical staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing, oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and intubation rates. We planned a prospective and retrospective study in order to check the feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well being, respiratory status and PICU admission.
Detailed description
Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study The research is devised as follows: Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016. Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.
Interventions
DEVICEHeatedHumidifiedHighFlowNasalCannula
We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. \[3\] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents. Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.
Sponsors
Rabin Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
in age interval, diagnosed with Bronchiolitis
Exclusion criteria
Chronic heart/lung disease, immunocompromised state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Bronchiolitis Severity Score grade | during the 20-40 hours of the protocol | The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CO2 pressure | during the 20-40 hours of the protocol | (in mmHg) measured by a transcutaneous sensor. |
| Medical interventions | during the 20-40 hours of the protocol | Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics. |
| Ability to take in food orally | during the 20-40 hours of the protocol | Whether the child has been able to feed - yes or no. |
| Number of Pediatric Intensive Care Unit (PICU) admissions | The whole hospitalization period of the child | Whether the child needed admission to PICU |
Countries
Israel
Contacts
Primary ContactEran Rom, Dr.
Backup ContactNimrod Sachs, Dr.
Outcome results
None listed