We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00757224
Recruitment Status : Unknown
Verified September 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2008
Last Update Posted : September 23, 2008
Sponsor:
Information provided by:

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
Tobacco Smoke Pollution Behavioral: Guidance

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2008
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. The number of episodes of cough/wheeze/asthma/bronchitis during the first 3 months and 1 year. [ Time Frame: 3 months and 1 year ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 23, 2008    Key Record Dates
Last Update Posted: September 23, 2008
Last Verified: September 2008