Trial Outcomes & Findings for NICU Asthma Education and Secondhand Smoke Reduction Study (NCT NCT00499915)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

165 participants

Primary outcome timeframe

5 months post baseline

Results posted on

2015-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 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.	Comparison 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 Study STARTED	83	82
Overall Study COMPLETED	68	76
Overall Study NOT COMPLETED	15	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NICU Asthma Education and Secondhand Smoke Reduction Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=83 Participants 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.	Comparison n=82 Participants 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 n=165 Participants Total of all reporting groups
Age, Continuous	28.7 Weeks STANDARD_DEVIATION 2.4 • n=93 Participants	28.1 Weeks STANDARD_DEVIATION 2.5 • n=4 Participants	28.4 Weeks STANDARD_DEVIATION 2.5 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	33 Participants n=4 Participants	67 Participants n=27 Participants
Sex: Female, Male Male	49 Participants n=93 Participants	49 Participants n=4 Participants	98 Participants n=27 Participants
Region of Enrollment United States	83 participants n=93 Participants	82 participants n=4 Participants	165 participants n=27 Participants

PRIMARY outcome

Timeframe: 5 months post baseline

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

Outcome measures

Outcome measures
Measure	Treatment n=68 Participants 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.	Comparison n=76 Participants 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.
Infants Living in Smoke-free Environments.	65 participants	64 participants

SECONDARY outcome

Timeframe: 2, 5, and 7-9 months post baseline

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparison

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=83 participants at risk 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.	Comparison n=82 participants at risk 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.
General disorders Death	1.2% 1/83 • Number of events 1 Only the infant participants were assessed for adverse events.	1.2% 1/82 • Number of events 1 Only the infant participants were assessed for adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jill Halterman

University of Rochester

Phone: 585-275-5798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place