Respiratory IllnessNCT00499915
NICU Asthma Education and Secondhand Smoke Reduction Study
A study testing Secondhand Smoke Reduction and Smoking Cessation Counseling and Asthma Education in people with Respiratory Illness, run by University of Rochester at 1 site in United States.
Trial summary
Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Illness
- What is being tested?
- Secondhand Smoke Reduction and Smoking Cessation Counseling and Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≤32 weeks gestation
- Planned discharge to home from the Neonatal Intensive Care Unit
- Parent or caregiver must consent to the intervention
- The first sibling discharged, for twins or infants from a multiple birth pregnancy
Who cannot join
- Inability to speak and understand English
- No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home)
- Family residence outside the greater Rochester area (more than 30 miles away)
- Children in foster care or other situations in which guardian consent cannot be obtained
- The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are:
- More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group).
- Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group.
- Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.
- Conditions
- Respiratory Illness
- Being tested
- Secondhand Smoke Reduction and Smoking Cessation Counseling, Asthma Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondhand Smoke Reduction and Smoking Cessation CounselingBehavioural
A secondhand smoke reduction program, including smoking cessation counseling (if appropriate), and feedback about the children's cotinine levels will be implemented using principles of Motivational Interviewing.
Asthma EducationBehavioural
Asthma education will be provided at NICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Secondhand Smoke Reduction and Asthma Education | Experimental | Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program. Receives: Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling; Behavioral: Asthma Education |
| Asthma Education | Active comparator | Parents of children in the active comparator group will receive asthma education at NICU discharge. Receives: Behavioral: Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants Living in Smoke-free Environments.
Infants living in homes with a "home smoking ban" rule
Measured: 5 months post baseline
Secondary outcomes (1)
Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.
Measured: 2, 5, and 7-9 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory IllnessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Halcyon Hill Foundation
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
- Investigators
- Jill S. Halterman, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499915
- Sponsor's protocol ID
- 15214
- Status last verified
- Oct 2015
- First submitted
- 10 Jul 2007
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
- ClinicalTrials.gov ID
- NCT00499915
- Acronym / sponsor ID
- 15214
- Conditions
- Respiratory Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Halcyon Hill Foundation
- Study start
- Feb 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are:
- More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group).
- Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group.
- Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondhand Smoke Reduction and Asthma Education | Experimental | Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling, Behavioral: Asthma EducationParents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program. |
| Asthma Education | Active comparator | Behavioral: Asthma EducationParents of children in the active comparator group will receive asthma education at NICU discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≤32 weeks gestation
- Planned discharge to home from the Neonatal Intensive Care Unit
- Parent or caregiver must consent to the intervention
- The first sibling discharged, for twins or infants from a multiple birth pregnancy
Key exclusion criteria (5 listed)
- Inability to speak and understand English
- No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home)
- Family residence outside the greater Rochester area (more than 30 miles away)
- Children in foster care or other situations in which guardian consent cannot be obtained
- The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures
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 |
|---|---|---|
| Secondhand Smoke Reduction and Smoking Cessation CounselingA secondhand smoke reduction program, including smoking cessation counseling (if appropriate), and feedback about the children's cotinine levels will be implemented using principles of Motivational Interviewing. | Behavioural | Secondhand Smoke Reduction and Asthma Education |
| Asthma EducationAsthma education will be provided at NICU discharge. | Behavioural | Asthma Education, Secondhand Smoke Reduction and Asthma Education |
Primary outcome
Infants Living in Smoke-free Environments.
Time frame: 5 months post baseline
Infants living in homes with a "home smoking ban" rule
1 secondary outcome
Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.
Time frame: 2, 5, and 7-9 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jill S. Halterman, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondhand Smoke Reduction and Smoking Cessation Counseling and Asthma Education in people with Respiratory Illness, run by University of Rochester 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 4 inclusion and 5 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 23 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Infants Living in Smoke-free Environments. (time frame: 5 months post baseline). 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 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.