NCT00757224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

September 23, 2008

Status Verified

September 1, 2008

Enrollment Period

1 month

First QC Date

September 21, 2008

Last Update Submit

September 22, 2008

Conditions

Tobacco Smoke Pollution

Outcome Measures

Primary Outcomes (1)

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

    3 months and 1 year

Secondary Outcomes (1)

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

    3 months and 1 year

Study Arms (3)

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

Interventions

GuidanceBEHAVIORAL

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.

smoking parents B

Eligibility Criteria

Age1 Day - 3 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants born at Asaf Harofeh Medical Center
  • Infants born at \>35W gestational age

You may not qualify if:

  • Infants requiring any supportive treatment (supplemental O2, fluids, glucose, antibiotics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Arnon Elizur, MD

CONTACT

972-8-9779817elizura@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 21, 2008

First Posted

September 23, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2008

Study Completion

October 1, 2009

Last Updated

September 23, 2008

Record last verified: 2008-09

Locations

IL(1)