NICU Asthma Education and Secondhand Smoke Reduction Study - Full Text View

Purpose

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.

Condition	Intervention
Respiratory Illness	Behavioral: Secondhand Smoke Reduction, Smoking Cessation Behavioral: Asthma Education with Secondhand Smoke Reduction

MedlinePlus related topics:

Asthma Premature Babies Smoking Smoking and Youth

ChemIDplus related topics:

Cotinine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

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

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Infants living in smoke-free environments. [ Time Frame: 2, 5, and 7-9 months post baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	February 2007
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.	Behavioral: Secondhand Smoke Reduction, Smoking Cessation Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels.
2: Active Comparator Parents of children in the active comparator group will receive asthma education at NICU discharge.	Behavioral: Asthma Education with Secondhand Smoke Reduction Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499915

Locations


United States, New York
	University of Rochester	Recruiting
	Rochester, New York, United States, 14642
	Contact: Kelly M. Conn, MPH 585-273-5693 kelly_conn@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

Halcyon Hill Foundation

Investigators


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

More Information

Responsible Party:	Halcyon Hill Foundation ( Jill S. Halterman, MD, MPH )
Study ID Numbers:	00015214
First Received:	July 10, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00499915
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Smoking

Asthma

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	University of Rochester Halcyon Hill Foundation
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00499915