NCT03053674

Brief Summary

The aim of this study is to determine whether an explanation to parents for the need for post-partum influenza vaccination will influence their compliance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 13, 2017

Last Update Submit

February 13, 2017

Conditions

Newborn Morbidity

Outcome Measures

Primary Outcomes (1)

  • Rate of post-partum influenza vaccination

    Telephone questionnaire to parents to determine compliance with vaccination

    2 months

Study Arms (2)

Explanation

EXPERIMENTAL

Explanation to parents on importance of post-partum influenza vaccination on health of their newborn infant with a follow-up questionnaire to determine rate of vaccination

Other: Oral and written explanationOther: Follow-up questionnaire

No explanation

ACTIVE COMPARATOR

No explanation will be given to parents but they will be followed-up with a questionnaire to determine rate of vaccination

Other: Follow-up questionnaire

Interventions

Oral and written explanationOTHER

Oral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant

Explanation
Follow-up questionnaireOTHER

Follow-up questionnaire to determine whether participants have receive post-partum vaccination

ExplanationNo explanation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All parents discharged from well-baby nursery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Amit Hochberg, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Hochberg, MD

CONTACT

amith@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Case-control study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

February 20, 2017

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)