PrematurityNCT01985620
The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate.
A study testing Educational intervention in people with Prematurity and RSV, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity, RSV, Influenza
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants coming for RSV prophylaxis
Who cannot join
- Already vaccinated against influenza
- Contraindication for influenza vaccination
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sourasky Medical Center
Tel Aviv
Guy Gut, Doctor, +972-3-6974614, guyg@tlvmc.gov.il
Guy Gut, Doctor
About this study
Official title: 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.
- Conditions
- Prematurity, RSV, Influenza, Upper Respiratory Tract Infection, Lower Respiratory Tract Infection
- Being tested
- Educational intervention
- Keywords
- Vaccination, RSV, Influenza, Prematurity
- Medical subject headings
- Premature Birth, Influenza, Human, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Educational intervention with the parents Receives: Behavioral: Educational intervention |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination rate
Measured: 5 months
Secondary outcomes (1)
respiratory morbidity
Upper and lower respiratory tract events during study period
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985620
- Sponsor's protocol ID
- TASMC-13-YS-0503-13-CTIL
- Other IDs
- 0503-13-TLV
- Status last verified
- Nov 2013
- First submitted
- 10 Nov 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Short Intervention During RSV Prophylaxis on Influenza Vaccination Rate and Morbidity in Infants Born Premature.
- ClinicalTrials.gov ID
- NCT01985620
- Acronym / sponsor ID
- TASMC-13-YS-0503-13-CTIL
- Conditions
- Prematurity, RSV, Influenza, Upper Respiratory Tract Infection, Lower Respiratory Tract Infection
- Keywords
- Vaccination, RSV, Influenza, Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (estimated)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Behavioral: Educational interventionEducational intervention with the parents |
| control group | No intervention | – |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants coming for RSV prophylaxis
Key exclusion criteria (2 listed)
- Already vaccinated against influenza
- Contraindication for influenza vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention | Behavioural | study group |
Primary outcome
Influenza vaccination rate
Time frame: 5 months
1 secondary outcome
respiratory morbidity
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Prematurity and RSV, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza vaccination rate (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.