Environmental Tobacco Smoke (ETS)Phase 2NCT00340106
Prevention of Environmental Tobacco Smoke Exposure in Children 0-12 Months Old
A Phase 2 study testing Counseling in people with Environmental Tobacco Smoke (ETS), run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial summary
This study will: 1) test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Environmental Tobacco Smoke (ETS)
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2005to 18 May 2010
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking women over age 18, who self-identify as African American, Black or Hispanic, live in the DC metropolitan area, and who have a singleton pregnancy will be enrolled in this study.
Who cannot join
- Exclusionary criteria include women reporting diagnosis of major psychiatric illnesses, current incarceration, or suicidal ideation, or who initiate prenatal care after 28 weeks. At postpartum, women who have lost custody of the child, are in withdrawal from addictive substances requiring hospitalization or methadone treatment will be deemed ineligible to remain in the study. Further, all women who report delivery complications requiring a hospital stay of 7 days or longer or the infants' admissions to the NICU (or NICU step down unit) for more than 12 hours, including infant prematurity less than 34 weeks, or infant birth weight less than 1800gm (i.e. 4.9 pounds) will be considered ineligible to continue in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GW University Medical Center
Washington D.C., District of Columbia, 20037
Providence Hospital
Washington D.C., District of Columbia
About this study
Official title: Prevention of Environmental Tobacco Smoke (ETS) Exposure to Children, Ages 0-12 Months
This study will: 1) test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants.
African-American and Hispanic women who are 18 years of age or older, and who are between 28 and 35 weeks pregnant may be eligible for this study. Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study, as follows:
Read more
Program A: Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development, such as ways to prevent childhood injuries caused by falls, poisons, and other hazards.
Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke. In addition, participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born.
Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B. Between visits, the Advisor calls the participant to check on her progress regarding the program objectives. In addition, the study involves the following for all participants:
- Telephone interview during the week after joining the study to obtain information on participant's background, pregnancy and family history, tobacco use and exposure to other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and exposure, stressful life events, drug and alcohol use during pregnancy, and sources of social support. Similar interviews are repeated when the baby is 6 weeks old, and again when the baby is 4 months, 6 months, and 12 months old.
- Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors (small plastic objects that measure the amount of tobacco smoke in the air of each room). The home visitor returns a week late...
Read the detailed description
ETS exposure is a major public health concern, and tobacco use is one of the 10 Healthy People 2010 leading health indicators. Despite the body of evidence showing the adverse effects of in-utero and postnatal exposure to tobacco smoke products (TSP) and environmental tobacco smoke (ETS) to the respiratory health in children, studies continue to be needed to elucidate when TSP exposure causes the greatest damage, possible mechanisms that underlie the damage, and how harm to the respiratory system of infants and vulnerable children can be prevented. and, while some efforts to reduce prenatal and childhood ETS exposure over the past decade have been successful, there is a paucity of randomized, controlled, intervention studies in the literature targeting ETS exposure reduction among infants age 0-12 months. Moreover, the effectiveness of ETS exposure prevention interventions in reducing the occurrence or severity of health symptoms and outcomes has rarely been systematically evaluated.
- Conditions
- Environmental Tobacco Smoke (ETS)
- Being tested
- Counseling
- Keywords
- Infant Health Study, Environmental Tobacco Smoke, Infant Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant ETS exposure 1)Maternal reports of infant ETS exposure at home and 2) Infant urinary cotinine levels.
Secondary outcomes (1)
Household ETS exposure levels, and maternal salivary cotinine levels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start25 Jul 2005
- Primary completion5 Mar 2010
- Study completion18 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Environmental Tobacco Smoke (ETS)Studies 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 2
- Primary purpose
- Treatment
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340106
- Sponsor's protocol ID
- 999905211
- Other IDs
- 05-CH-N211
- Status last verified
- 18 May 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Lodrup Carlsen KC, Carlsen KH. Effects of maternal and early tobacco exposure on the development of asthma and airway hyperreactivity. Curr Opin Allergy Clin Immunol. 2001 Apr;1(2):139-43. doi: 10.1097/01.all.0000010998.15560.b6.
PubMed 11964681Chan-Yeung M, Manfreda J, Dimich-Ward H, Ferguson A, Watson W, Becker A. A randomized controlled study on the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants. Arch Pediatr Adolesc Med. 2000 Jul;154(7):657-63. doi: 10.1001/archpedi.154.7.657.
PubMed 10891016Chilmonczyk BA, Palomaki GE, Knight GJ, Williams J, Haddow JE. An unsuccessful cotinine-assisted intervention strategy to reduce environmental tobacco smoke exposure during infancy. Am J Dis Child. 1992 Mar;146(3):357-60. doi: 10.1001/archpedi.1992.02160150097031.
PubMed 1543187
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Environmental Tobacco Smoke (ETS) Exposure to Children, Ages 0-12 Months
- ClinicalTrials.gov ID
- NCT00340106
- Acronym / sponsor ID
- 999905211
- Conditions
- Environmental Tobacco Smoke (ETS)
- Keywords
- Infant Health Study, Environmental Tobacco Smoke, Infant Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Jul 2005
- Primary completion
- 5 Mar 2010 (actual)
- Study completion
- 18 May 2010 (actual)
- First posted
- 21 Jun 2006 (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.
This study will: 1) test the effectiveness of a program to prevent the exposure of infants to environmental tobacco smoke; and 2) evaluate the health effects associated with prenatal and postpartum exposure to tobacco smoke products and environmental tobacco smoke among infants.
African-American and Hispanic women who are 18 years of age or older, and who are between 28 and 35 weeks pregnant may be eligible for this study. Participants complete an interview and home visit assessment and are then randomly assigned to participate in Program A or Program B of the study, as follows:
Program A: Involves discussions with an Infant Health Advisor about parenting skills to promote child safety and infant growth and development, such as ways to prevent childhood injuries caused by falls, poisons, and other hazards.
Program B: Involves discussions with an Infant Health Advisor about ways to prevent infant tobacco smoke exposure, such as how to adopt smoke-free household rules in the home and how to work with friends and family members to prevent the baby from being exposed to tobacco smoke. In addition, participants who smoked cigarettes before becoming pregnant or while pregnant are given advice on how to quit smoking and how to remain a non-smoker once the baby is born.
Participants come to the clinic four times- once during a regularly scheduled prenatal visit and again when the baby is 6 weeks, 4 months, and 6 months old - to see the Infant Health Advisor for the activities described above in Program A or Program B. Between visits, the Advisor calls the participant to check on her progress regarding the program objectives. In addition, the study involves the following for all participants:
- Telephone interview during the week after joining the study to obtain information on participant's background, pregnancy and family history, tobacco use and exposure to other people's cigarette smoke during pregnancy, strategies to reduce tobacco use and exposure, stressful life events, drug and alcohol use during pregnancy, and sources of social support. Similar interviews are repeated when the baby is 6 weeks old, and again when the baby is 4 months, 6 months, and 12 months old.
- Home visit about 1 week after entering the study to check the home for possible safety hazards to the baby and to place one or more nicotine air monitors (small plastic objects that measure the amount of tobacco smoke in the air of each room). The home visitor returns a week late...
Detailed description
ETS exposure is a major public health concern, and tobacco use is one of the 10 Healthy People 2010 leading health indicators. Despite the body of evidence showing the adverse effects of in-utero and postnatal exposure to tobacco smoke products (TSP) and environmental tobacco smoke (ETS) to the respiratory health in children, studies continue to be needed to elucidate when TSP exposure causes the greatest damage, possible mechanisms that underlie the damage, and how harm to the respiratory system of infants and vulnerable children can be prevented. and, while some efforts to reduce prenatal and childhood ETS exposure over the past decade have been successful, there is a paucity of randomized, controlled, intervention studies in the literature targeting ETS exposure reduction among infants age 0-12 months. Moreover, the effectiveness of ETS exposure prevention interventions in reducing the occurrence or severity of health symptoms and outcomes has rarely been systematically evaluated.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking women over age 18, who self-identify as African American, Black or Hispanic, live in the DC metropolitan area, and who have a singleton pregnancy will be enrolled in this study.
Key exclusion criteria (1 listed)
- Exclusionary criteria include women reporting diagnosis of major psychiatric illnesses, current incarceration, or suicidal ideation, or who initiate prenatal care after 28 weeks. At postpartum, women who have lost custody of the child, are in withdrawal from addictive substances requiring hospitalization or methadone treatment will be deemed ineligible to remain in the study. Further, all women who report delivery complications requiring a hospital stay of 7 days or longer or the infants' admissions to the NICU (or NICU step down unit) for more than 12 hours, including infant prematurity less than 34 weeks, or infant birth weight less than 1800gm (i.e. 4.9 pounds) will be considered ineligible to continue in the study.
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 |
|---|---|---|
| Counseling | Behavioural | – |
Primary outcome
Infant ETS exposure 1)Maternal reports of infant ETS exposure at home and 2) Infant urinary cotinine levels.
1 secondary outcome
Household ETS exposure levels, and maternal salivary cotinine levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11964681Lodrup Carlsen KC, Carlsen KH. Effects of maternal and early tobacco exposure on the development of asthma and airway hyperreactivity. Curr Opin Allergy Clin Immunol. 2001 Apr;1(2):139-43. doi: 10.1097/01.all.0000010998.15560.b6.
- Background: PubMed 10891016Chan-Yeung M, Manfreda J, Dimich-Ward H, Ferguson A, Watson W, Becker A. A randomized controlled study on the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants. Arch Pediatr Adolesc Med. 2000 Jul;154(7):657-63. doi: 10.1001/archpedi.154.7.657.
- Background: PubMed 1543187Chilmonczyk BA, Palomaki GE, Knight GJ, Williams J, Haddow JE. An unsuccessful cotinine-assisted intervention strategy to reduce environmental tobacco smoke exposure during infancy. Am J Dis Child. 1992 Mar;146(3):357-60. doi: 10.1001/archpedi.1992.02160150097031.
Related trials for Environmental Tobacco Smoke (ETS)
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Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
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Secondhand Smoke Respiratory Health Study
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Early Life Intervention in Pediatrics Supported by E-health - SMOKE
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The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Counseling in people with Environmental Tobacco Smoke (ETS), run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant ETS exposure 1)Maternal reports of infant ETS exposure at home and 2) Infant urinary cotinine levels.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340106, which also lists 3 linked publications.
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 2 Jul 2017.