NICU Asthma Education and Secondhand Smoke Reduction Study

October 20, 2015 updated by: Jill Halterman, University of Rochester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Behavioral: Asthma Education
Asthma education will be provided at NICU discharge.
Active Comparator: Asthma Education
Parents of children in the active comparator group will receive asthma education at NICU discharge.
Behavioral: Asthma Education
Asthma education will be provided at NICU discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infants Living in Smoke-free Environments.
Time Frame: 5 months post baseline
Infants living in homes with a "home smoking ban" rule
5 months post baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2, 5, and 7-9 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Halcyon Hill Foundation

Investigators

  • Principal Investigator: Jill S. Halterman, MD, MPH, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 15214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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