Newborn MorbidityNCT03053674
Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination
A study testing Oral and written explanation and Follow-up questionnaire in people with Newborn Morbidity, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Newborn Morbidity
- What is being tested?
- Oral and written explanation and Follow-up questionnaire
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Feb 2017to 1 Jul 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All parents discharged from well-baby nursery
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Amit Hochberg, MD contact
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Amit Hochberg, MD, amith@hy.health.gov.il
About this study
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.
- Conditions
- Newborn Morbidity
- Being tested
- Oral and written explanation, Follow-up questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral and written explanationOther
Oral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant
Follow-up questionnaireOther
Follow-up questionnaire to determine whether participants have receive post-partum vaccination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Oral and written explanation; Other: 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 Receives: Other: Follow-up questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-partum influenza vaccination
Telephone questionnaire to parents to determine compliance with vaccination
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start20 Feb 2017 (estimated)
- Primary completion1 Apr 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- 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
- Model description
- Case-control study
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amit Hochberg, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053674
- Sponsor's protocol ID
- HYMC104-16
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Explanation Given to Parents on Rate of Post-partum Influenza Vaccination
- ClinicalTrials.gov ID
- NCT03053674
- Acronym / sponsor ID
- HYMC104-16
- Conditions
- Newborn Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 20 Feb 2017 (estimated)
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 15 Feb 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Case-control study
| Arm | Type | Receives |
|---|---|---|
| Explanation | Experimental | Other: Oral and written explanation, Other: Follow-up questionnaireExplanation 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 |
| No explanation | Active comparator | Other: Follow-up questionnaireNo explanation will be given to parents but they will be followed-up with a questionnaire to determine rate of vaccination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All parents discharged from well-baby nursery
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Oral and written explanationOral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant | Other | Explanation |
| Follow-up questionnaireFollow-up questionnaire to determine whether participants have receive post-partum vaccination | Other | Explanation, No explanation |
Primary outcome
Rate of post-partum influenza vaccination
Time frame: 2 months
Telephone questionnaire to parents to determine compliance with vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Amit Hochberg, MD contact
Amit Hochberg, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral and written explanation and Follow-up questionnaire in people with Newborn Morbidity, run by Hillel Yaffe 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 1 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 15 Feb 2017. 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?
Contact Amit Hochberg, MD (amith@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-partum influenza vaccination (time frame: 2 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 15 Feb 2017.