Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00757224

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoke Pollution	Behavioral: Guidance	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Oct 1, 2008

Anticipated Primary Completion Date :

Nov 1, 2008

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: non-smoking
No Intervention: smoking parents A
Experimental: smoking parents B Parents will be educated on the hazards of passive smoke exposure and ways to reduce it	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.

Arm

Intervention/Treatment

No Intervention: non-smoking

No Intervention: smoking parents A

Experimental: smoking parents B

Parents will be educated on the hazards of passive smoke exposure and ways to reduce it

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.

Outcome Measures

Primary Outcome Measures

The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year. [3 months and 1 year]

Secondary Outcome Measures

The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year [3 months and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 3 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asaf Harofeh Medical Center	Zerifin		Israel	70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00757224

Other Study ID Numbers:

147/08

First Posted:

Sep 23, 2008

Last Update Posted:

Sep 23, 2008

Last Verified:

Sep 1, 2008

Study Results

No Results Posted as of Sep 23, 2008