Tobacco Smoke PollutionNCT00757224
Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants
A study testing Guidance in people with Tobacco Smoke Pollution, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants. Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided… Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoke Pollution
- What is being tested?
- Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2008to Oct 2009
- 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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born at Asaf Harofeh Medical Center
- Infants born at >35W gestational age
Who cannot join
- Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Asaf Harofeh Medical Center
Tsrifin, 70300
Arnon Elizur, MD, 972-8-9779817, elizura@gmail.com
About this study
Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants.
Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.
Read the detailed description
Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.
- Conditions
- Tobacco Smoke Pollution
- Being tested
- Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuidanceBehavioural
Smoking parents will receive education on the association between parental smoking and respiratory morbidity in the infant. They will also be offered ways to reduce smoke exposure of their infants.
| Study group | Role | What they receive |
|---|---|---|
| non-smoking | No intervention | Not described |
| smoking parents A | No intervention | Not described |
| smoking parents B | Experimental | Parents will be educated on the hazards of passive smoke exposure and ways to reduce it Receives: Behavioral: Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year.
Measured: 3 months and 1 year
Secondary outcomes (1)
The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoke PollutionStudies 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757224
- Sponsor's protocol ID
- 147/08
- Status last verified
- Sep 2008
- First submitted
- 21 Sep 2008
- Last updated
- 23 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants
- ClinicalTrials.gov ID
- NCT00757224
- Acronym / sponsor ID
- 147/08
- Conditions
- Tobacco Smoke Pollution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 23 Sep 2008 (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.
Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants.
Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.
Detailed description
Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-smoking | No intervention | – |
| smoking parents A | No intervention | – |
| smoking parents B | Experimental | Behavioral: GuidanceParents will be educated on the hazards of passive smoke exposure and ways to reduce it |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born at Asaf Harofeh Medical Center
- Infants born at >35W gestational age
Key exclusion criteria (1 listed)
- Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)
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 |
|---|---|---|
| GuidanceSmoking parents will receive education on the association between parental smoking and respiratory morbidity in the infant. They will also be offered ways to reduce smoke exposure of their infants. | Behavioural | smoking parents B |
Primary outcome
The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year.
Time frame: 3 months and 1 year
1 secondary outcome
The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
Related trials for Tobacco Smoke Pollution
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
Active, not recruiting
Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke
Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of COPD
Recruiting
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
Healthy
Not yet recruitingPhase 4
Statins Against Bushfire Smoke
Healthy Adults
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 Guidance in people with Tobacco Smoke Pollution, run by Assaf-Harofeh 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 2 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 23 Sep 2008. 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 Arnon Elizur, MD (972-8-9779817, elizura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year. (time frame: 3 months and 1 year). 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 23 Sep 2008.