NCT01985620

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

June 26, 2014

Status Verified

November 1, 2013

Enrollment Period

1.4 years

First QC Date

November 10, 2013

Last Update Submit

June 25, 2014

Conditions

PrematurityRSVInfluenzaUpper Respiratory Tract InfectionLower Respiratory Tract Infection

Keywords

VaccinationRSVInfluenzaPrematurity

Outcome Measures

Primary Outcomes (1)

  • Influenza vaccination rate

    5 months

Secondary Outcomes (1)

  • respiratory morbidity

    5 months

Study Arms (2)

study group

ACTIVE COMPARATOR

Educational intervention with the parents

Behavioral: Educational intervention

control group

NO INTERVENTION

Interventions

Educational interventionBEHAVIORAL
study group

Eligibility Criteria

Age6 Months - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants coming for RSV prophylaxis

You may not qualify if:

  • Already vaccinated against influenza
  • Contraindication for influenza vaccination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Premature BirthInfluenza, HumanRespiratory Tract Infections

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Last Updated

June 26, 2014

Record last verified: 2013-11

Locations

IL(1)