Infant Environmental Tobacco Smoke ExposureNCT00670280
Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes
A study testing Motivational Interviewing intervention in people with Infant Environmental Tobacco Smoke Exposure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study is about reducing the risks of smoke-related infant health problems. Research has shown that infants exposed to secondary smoke have higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Infant Environmental Tobacco Smoke Exposure
- What is being tested?
- Motivational Interviewing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Nov 2011
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- have an infant that is 2-3 weeks prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital
- have an infant at high respiratory risk (very low birth weight or received mechanical ventilation for >12 hours)
- report at least one person in the home who usually smokes >6 cigarettes/week in the house
- speak English or Spanish
- agree to the assessments
- attend intervention sessions (anyone who smokes in the home would be asked but not required to attend)
Show all 9Show fewer
- live within 50 miles of our center
- have access to a telephone
- provide informed consent
Who cannot join
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation, including parental consent if under age 18 (unless caregiver is an emancipated minor)
- inability or unwillingness to meet study requirements, including follow-up home visits for data collection purposes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: Reducing Environmental Tobacco Smoke in NICU Infants' Homes
This study is about reducing the risks of smoke-related infant health problems. Research has shown that infants exposed to secondary smoke have higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Infants who have experienced low birth weight or required mechanical ventilation may be at an even greater risk for the negative effects of smoking. The purpose of this study is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care giver in reducing risks to their child's health by decreasing infant smoke exposure in their home and/or reducing overall cigarette use.
Caregivers will not be required to quit smoking to take part in this program. This information will, in the future, help to identify and improve ways of reducing health problems and perhaps death in children.
Read the detailed description
Approximately 38% of children aged 2 months to 5 years are exposed to environmental tobacco smoke (ETS), and compelling evidence suggests rates are even higher in low-income, less educated households. The adverse health effects of chronic ETS in children are well documented and include higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease and sudden infant death syndrome. Preterm infants admitted to a Neonatal Intensive Care Unit (NICU) are particularly vulnerable to the effects of ETS, typically exhibiting significant respiratory or chronic lung conditions prior to discharge.
The primary aim of this investigation is to develop and verify the feasibility and efficacy of a multicomponent behavioral intervention for reducing ETS exposure in a low-income, multi-ethnic population of NICU infants at particularly high social and medical risk for adverse effects of ETS. A randomized, controlled, between groups design will be used to test a hospital-based ETS reduction program based on motivational interviewing (MI). A total of 150 families with an infant at high respiratory risk in the NICU who report regular household smoking will be randomized to either MI or Usual Care. The MI intervention will include 2 one-hour counseling sessions within the 2 weeks prior to infant discharge and one telephone counseling call at two weeks post-discharge. Counseling and interviews will be conducted in Spanish or English.
The proposed research brings together highly experienced behavioral and clinical investigators, an extraordinary infrastructure, and a large population easily accessible for intervention prior to discharge. Effective brief, hospital-based interventions to reduce ETS exposure in households with NICU infants at high respiratory risk could result in substantial decreases in adverse health effects and the very large associated costs.
- Being tested
- Motivational Interviewing intervention, Usual Care, Usual Care - Reduced Measurement
- Keywords
- Neonatal Intensive Care Units, Infant Morbidity, Low Birth Weight, Low Income Populations, MCH Research, Respiratory Illnesses, Substance Exposed Infants, Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing interventionBehavioural
Those randomized to receive the Motivational Interviewing intervention will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. Each visit will consist of a 45 minute session in which household smoking practices will be assessed and discussed. Two weeks after the child has been discharged from the hospital, the counselor will contact participants via telephone for a third 20-30 minute telephone meeting. After the third contact with the counselor, a letter will be mailed to participants summarizing information covered in the three meetings.
Usual CareBehavioural
Those randomized to receive the Usual Care intervention will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention.
Usual Care - Reduced MeasurementBehavioural
Those randomized to the Usual Care - Reduced Measurement intervention will receive the same written information on secondary smoke and infant health as the Usual Care intervention but will be assessed only at the 6-month timepoint.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Those randomized to the Intervention group will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. Receives: Behavioral: Motivational Interviewing intervention |
| UC Group | Active comparator | Those randomized to the Usual Care group will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention. Receives: Behavioral: Usual Care |
| UC-RM Group | Active comparator | Those randomized to the Usual Care - Reduced Measurement group will receive the same information as the Usual Care group but will be measured less often (only at 6 months post-intervention). Receives: Behavioral: Usual Care - Reduced Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variables will include both objective (household air nicotine levels; infant ETCO levels) and self-report measures of household ETS exposure.
Measured: 6 months post-intervention
Secondary outcomes (4)
In addition to achieving lower infant smoke exposure rates in the MI condition, we expect MI will produce significant changes in several domains (e.g. self-efficacy, motivation to change).
Measured: 1 month, 3 months, and 6 months post-intervention
Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on respiratory symptoms and diagnoses.
Measured: 1 month, 3 months, and 6 months post-intervention
Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on healthcare utilization.
Measured: 1 month, 3 months, and 6 months post-intervention
Finally, the impact on ETS outcomes of having an infant with Bronchopulmonary Dysplasia will be explored.
Measured: 1 month, 3 months, and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Environmental Tobacco Smoke ExposureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Angela Stotts, The University of Texas Health Science Center, Houston
- Investigators
- Angela L Stotts, Ph.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670280
- Sponsor's protocol ID
- R40 MC 08962-01
- Status last verified
- Jan 2016
- First submitted
- 29 Apr 2008
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Environmental Tobacco Smoke in NICU Infants' Homes
- ClinicalTrials.gov ID
- NCT00670280
- Acronym / sponsor ID
- R40 MC 08962-01
- Keywords
- Neonatal Intensive Care Units, Infant Morbidity, Low Birth Weight, Low Income Populations, MCH Research, Respiratory Illnesses, Substance Exposed Infants, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- May 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 May 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.
This study is about reducing the risks of smoke-related infant health problems. Research has shown that infants exposed to secondary smoke have higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Infants who have experienced low birth weight or required mechanical ventilation may be at an even greater risk for the negative effects of smoking. The purpose of this study is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care giver in reducing risks to their child's health by decreasing infant smoke exposure in their home and/or reducing overall cigarette use.
Caregivers will not be required to quit smoking to take part in this program. This information will, in the future, help to identify and improve ways of reducing health problems and perhaps death in children.
Detailed description
Approximately 38% of children aged 2 months to 5 years are exposed to environmental tobacco smoke (ETS), and compelling evidence suggests rates are even higher in low-income, less educated households. The adverse health effects of chronic ETS in children are well documented and include higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease and sudden infant death syndrome. Preterm infants admitted to a Neonatal Intensive Care Unit (NICU) are particularly vulnerable to the effects of ETS, typically exhibiting significant respiratory or chronic lung conditions prior to discharge.
The primary aim of this investigation is to develop and verify the feasibility and efficacy of a multicomponent behavioral intervention for reducing ETS exposure in a low-income, multi-ethnic population of NICU infants at particularly high social and medical risk for adverse effects of ETS. A randomized, controlled, between groups design will be used to test a hospital-based ETS reduction program based on motivational interviewing (MI). A total of 150 families with an infant at high respiratory risk in the NICU who report regular household smoking will be randomized to either MI or Usual Care. The MI intervention will include 2 one-hour counseling sessions within the 2 weeks prior to infant discharge and one telephone counseling call at two weeks post-discharge. Counseling and interviews will be conducted in Spanish or English.
The proposed research brings together highly experienced behavioral and clinical investigators, an extraordinary infrastructure, and a large population easily accessible for intervention prior to discharge. Effective brief, hospital-based interventions to reduce ETS exposure in households with NICU infants at high respiratory risk could result in substantial decreases in adverse health effects and the very large associated costs.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Motivational Interviewing interventionThose randomized to the Intervention group will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. |
| UC Group | Active comparator | Behavioral: Usual CareThose randomized to the Usual Care group will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention. |
| UC-RM Group | Active comparator | Behavioral: Usual Care - Reduced MeasurementThose randomized to the Usual Care - Reduced Measurement group will receive the same information as the Usual Care group but will be measured less often (only at 6 months post-intervention). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- have an infant that is 2-3 weeks prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital
- have an infant at high respiratory risk (very low birth weight or received mechanical ventilation for >12 hours)
- report at least one person in the home who usually smokes >6 cigarettes/week in the house
- speak English or Spanish
- agree to the assessments
Key exclusion criteria (4 listed)
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation, including parental consent if under age 18 (unless caregiver is an emancipated minor)
- inability or unwillingness to meet study requirements, including follow-up home visits for data collection purposes
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 |
|---|---|---|
| Motivational Interviewing interventionThose randomized to receive the Motivational Interviewing intervention will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. Each visit will consist of a 45 minute session in which household smoking practices will be assessed and discussed. Two weeks after the child has been discharged from the hospital, the counselor will contact participants via telephone for a third 20-30 minute telephone meeting. After the third contact with the counselor, a letter will be mailed to participants summarizing information covered in the three meetings. | Behavioural | Intervention Group |
| Usual CareThose randomized to receive the Usual Care intervention will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention. | Behavioural | UC Group |
| Usual Care - Reduced MeasurementThose randomized to the Usual Care - Reduced Measurement intervention will receive the same written information on secondary smoke and infant health as the Usual Care intervention but will be assessed only at the 6-month timepoint. | Behavioural | UC-RM Group |
Primary outcome
Primary efficacy variables will include both objective (household air nicotine levels; infant ETCO levels) and self-report measures of household ETS exposure.
Time frame: 6 months post-intervention
4 secondary outcomes
In addition to achieving lower infant smoke exposure rates in the MI condition, we expect MI will produce significant changes in several domains (e.g. self-efficacy, motivation to change).
Time frame: 1 month, 3 months, and 6 months post-intervention
Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on respiratory symptoms and diagnoses.
Time frame: 1 month, 3 months, and 6 months post-intervention
Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on healthcare utilization.
Time frame: 1 month, 3 months, and 6 months post-intervention
Finally, the impact on ETS outcomes of having an infant with Bronchopulmonary Dysplasia will be explored.
Time frame: 1 month, 3 months, and 6 months post-intervention
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 6 Jan 2016.
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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.
Angela L Stotts, Ph.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing intervention in people with Infant Environmental Tobacco Smoke Exposure, run by The University of Texas Health Science Center, Houston at 1 site 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 9 inclusion and 4 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 6 Jan 2016. 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 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.
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?
Primary efficacy variables will include both objective (household air nicotine levels; infant ETCO levels) and self-report measures of household ETS exposure. (time frame: 6 months post-intervention). 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 6 Jan 2016.