NICU Asthma Education and Secondhand Smoke Reduction Study

Respiratory Illness Clinical Trial

Official title:

Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499915
• Other study ID #: 15214
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: October 20, 2015
• Start date: February 2007
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Illness

Intervention

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.
• Asthma Education
Asthma education will be provided at NICU discharge.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Halcyon Hill Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infants Living in Smoke-free Environments.	Infants living in homes with a "home smoking ban" rule	5 months post baseline	Yes
Secondary	Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.		2, 5, and 7-9 months post baseline	No