Parental Education on Passive Smoke Exposure and Respiratory Diseases in Infants

September 22, 2008 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

September 21, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (Estimate)

September 23, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2008

Last Update Submitted That Met QC Criteria

September 22, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • 147/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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