Respiratory Illness Clinical Trial
Official title:
Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Halcyon Hill Foundation |
United States,
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 |
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