The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.

June 25, 2014 updated by: Tel-Aviv Sourasky Medical Center

The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Aviv, Israel
        • Recruiting
        • Sourasky Medical Center
        • Contact:
        • Sub-Investigator:
          • Guy Gut, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants coming for RSV prophylaxis

Exclusion Criteria:

  • Already vaccinated against influenza
  • Contraindication for influenza vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Active Comparator: study group
Educational intervention with the parents
Behavioral: Educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Influenza vaccination rate
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory morbidity
Time Frame: 5 months
Upper and lower respiratory tract events during study period
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-YS-0503-13-CTIL
  • 0503-13-TLV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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