NICU Asthma Education and Secondhand Smoke Reduction Study

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00499915
• Collaborator: Halcyon Hill Foundation (Other)
• Enrollment: 165
• Location: 1
• Arms: 2
• Duration (Months): 99.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Illness	Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling; Behavioral: Asthma Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Infants Living in Smoke-free Environments. [5 months post baseline]

   Infants living in homes with a "home smoking ban" rule

Secondary Outcome Measures

1. Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses. [2, 5, and 7-9 months post baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• Halcyon Hill Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jill Halterman, Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT00499915
• Other Study ID Numbers: 15214
• First Posted: Jul 12, 2007
• Last Update Posted: Nov 23, 2015
• Last Verified: Oct 1, 2015

Study Results

Participant Flow

Arm/Group Title	Treatment	Comparison
Arm/Group Description	Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. 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.	Parents of children in the active comparator group will receive asthma education at NICU discharge. 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.
Period Title: Overall Study
STARTED	83	82
COMPLETED	68	76
NOT COMPLETED	15	6

Baseline Characteristics

Arm/Group Title	Treatment	Comparison	Total
Arm/Group Description	Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. 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.	Parents of children in the active comparator group will receive asthma education at NICU discharge. 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.	Total of all reporting groups
Overall Participants	83	82	165
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	28.7 (2.4)	28.1 (2.5)	28.4 (2.5)
Sex: Female, Male (Count of Participants)
Female	34 41%	33 40.2%	67 40.6%
Male	49 59%	49 59.8%	98 59.4%
Region of Enrollment (participants) [Number]
United States	83 100%	82 100%	165 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment	Comparison
Arm/Group Description	Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. 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.	Parents of children in the active comparator group will receive asthma education at NICU discharge. 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.
Measure Participants	68	76
Number [participants]	65 78.3%	64 78%

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Adverse Event Reporting Description	Only the infant participants were assessed for adverse events.
Arm/Group Title	Treatment		Comparison
Arm/Group Description	Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. 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.		Parents of children in the active comparator group will receive asthma education at NICU discharge. 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.
All Cause Mortality
	Treatment		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/83 (1.2%)		1/82 (1.2%)
General disorders
Death	1/83 (1.2%)	1	1/82 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Treatment		Comparison
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/82 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.