Back to resultsThe Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
Primary Purpose
Prematurity, RSV, Influenza
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Prematurity focused on measuring Vaccination, RSV, Influenza, Prematurity
Eligibility Criteria
Inclusion Criteria:
- Infants coming for RSV prophylaxis
Exclusion Criteria:
- Already vaccinated against influenza
- Contraindication for influenza vaccination
Sites / Locations
- Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
study group
control group
Arm Description
Educational intervention with the parents
Outcomes
Primary Outcome Measures
Influenza vaccination rate
Secondary Outcome Measures
respiratory morbidity
Upper and lower respiratory tract events during study period
Full Information
NCT ID
NCT01985620
First Posted
November 10, 2013
Last Updated
June 25, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01985620
Brief Title
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
Official Title
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, RSV, Influenza, Upper Respiratory Tract Infection, Lower Respiratory Tract Infection
Keywords
Vaccination, RSV, Influenza, Prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Active Comparator
Arm Description
Educational intervention with the parents
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Primary Outcome Measure Information:
Title
Influenza vaccination rate
Time Frame
5 months
Secondary Outcome Measure Information:
Title
respiratory morbidity
Description
Upper and lower respiratory tract events during study period
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants coming for RSV prophylaxis
Exclusion Criteria:
Already vaccinated against influenza
Contraindication for influenza vaccination
Facility Information:
Facility Name
Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Gut, Doctor
Phone
+972-3-6974614
Email
guyg@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Guy Gut, Doctor
12. IPD Sharing Statement
Learn more about this trial
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
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