Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

Tobacco Smoke Pollution Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00757224
• Other study ID #: 147/08
• Status: Not yet recruiting
• Phase: N/A
• First received: September 21, 2008
• Last updated: September 22, 2008
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: September 2008
• Source: Assaf-Harofeh Medical Center
• Contact: Arnon Elizur, MD
• Phone: 972-8-9779817
• Email: elizura[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Parental smoking is associated with increased frequency of respiratory diseases including hospitalizations in infants.

Study hypothesis: Parental education regarding the association between parental smoking and respiratory diseases in the infant, and guidance on ways to decrease smoke exposure by the infant, provided shortly after the infant is born, will decrease infants' morbidity.

Description:

Mothers who are in Maternity ward following birth will fill a questionnaire regarding smoking habits. Parents will be divided into non-smokers and smokers. Half of the smoking mothers will receive guidance regarding the association between parents smoking and respiratory diseases in the infant. They will also get ideas on how to reduce smoke exposure by their infant. 3 months and 1 year later all parents will be contacted by phone and asked about their children's health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• Infants born at Asaf Harofeh Medical Center

• Infants born at >35W gestational age

Exclusion Criteria:

• Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Smoke Pollution

Intervention

Behavioral:
• Guidance
Smoking parents will receive education on the association between parental smoking and respiratory morbidity in the infant. They will also be offered ways to reduce smoke exposure of their infants.

Locations

Country	Name	City	State
Israel	Asaf Harofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year.		3 months and 1 year	No
Secondary	The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year		3 months and 1 year	No