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NICU Asthma Education and Secondhand Smoke Reduction Study

NCT ID: NCT00499915

Last Updated: 2015-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Secondhand Smoke Reduction and Asthma Education

Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program.

Group Type EXPERIMENTAL

Secondhand Smoke Reduction and Smoking Cessation Counseling

Intervention Type BEHAVIORAL

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 Education

Intervention Type BEHAVIORAL

Asthma education will be provided at NICU discharge.

Asthma Education

Parents of children in the active comparator group will receive asthma education at NICU discharge.

Group Type ACTIVE_COMPARATOR

Asthma Education

Intervention Type BEHAVIORAL

Asthma education will be provided at NICU discharge.

Interventions

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Secondhand Smoke Reduction and Smoking Cessation Counseling

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.

Intervention Type BEHAVIORAL

Asthma Education

Asthma education will be provided at NICU discharge.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ≤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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Halcyon Hill Foundation

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Jill Halterman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill S. Halterman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15214

Identifier Type: -

Identifier Source: org_study_id