Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants - Full Text View

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00757224

Purpose

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	Intervention
Tobacco Smoke Pollution	Behavioral: Guidance

MedlinePlus related topics: Smoking Smoking and Youth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year. [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of ED visits and hospitalizations for respiratory diseases in the first 3 months and 1 year [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
non-smoking: No Intervention
smoking parents A: No Intervention
smoking parents B: Experimental 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.

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.

Eligibility

Ages Eligible for Study:	up to 3 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757224

Contacts

Contact: Arnon Elizur, MD

972-8-9779817

elizura@gmail.com

Locations

Israel
Asaf Harofeh Medical Center
Zerifin, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

No publications provided

Responsible Party:	The institute of allergy and pulmonary medicine, Asaf Harofeh Medical Center ( Arnon Elizur, MD )
Study ID Numbers:	147/08
Study First Received:	September 21, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00757224 History of Changes
Health Authority:	Israel: Ethics Commission

Study placed in the following topic categories:

Smoking
Respiration Disorders

ClinicalTrials.gov processed this record on May 07, 2009