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Trial record 14 of 762 for:    Tobacco Smoke

NICU Asthma Education and Secondhand Smoke Reduction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00499915
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborator:
Halcyon Hill Foundation
Information provided by (Responsible Party):
Jill Halterman, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Respiratory Illness
Interventions Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling
Behavioral: Asthma Education
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Comparison
Hide 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
Arm/Group Title Treatment Comparison Total
Hide 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 Number of Baseline Participants 83 82 165
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 83 participants 82 participants 165 participants
28.7  (2.4) 28.1  (2.5) 28.4  (2.5)
[1]
Measure Description: Gestational Age (weeks)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 82 participants 165 participants
Female
34
  41.0%
33
  40.2%
67
  40.6%
Male
49
  59.0%
49
  59.8%
98
  59.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 83 participants 82 participants 165 participants
83 82 165
1.Primary Outcome
Title Infants Living in Smoke-free Environments.
Hide Description Infants living in homes with a "home smoking ban" rule
Time Frame 5 months post baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparison
Hide 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.

Overall Number of Participants Analyzed 68 76
Measure Type: Number
Unit of Measure: participants
65 64
2.Secondary Outcome
Title Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.
Hide Description [Not Specified]
Time Frame 2, 5, and 7-9 months post baseline
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Only the infant participants were assessed for adverse events.
 
Arm/Group Title Treatment Comparison
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Comparison
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/83 (1.20%)      1/82 (1.22%)    
General disorders     
Death  [1]  1/83 (1.20%)  1 1/82 (1.22%)  1
Indicates events were collected by systematic assessment
[1]
All infants in this study are born premature and at risk for other complications. These children passed away while enrolled in this study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Comparison
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/83 (0.00%)      0/82 (0.00%)    
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.
Results Point of Contact
Name/Title: Dr. Jill Halterman
Organization: University of Rochester
Phone: 585-275-5798
Responsible Party: Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier: NCT00499915     History of Changes
Other Study ID Numbers: 15214
First Submitted: July 10, 2007
First Posted: July 12, 2007
Results First Submitted: September 15, 2015
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015