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Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00757224
First received: September 21, 2008
Last updated: September 22, 2008
Last verified: September 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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
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.

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 Not yet recruiting
Zerifin, Israel, 70300
Contact: Arnon Elizur, MD     972-8-9779817     elizura@gmail.com    
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

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

ClinicalTrials.gov processed this record on June 18, 2013