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NCT00248391 Clinical Trial

The Influence of Feeding Position on Pulmonary Morbidity in Young Children

Dental Caries Clinical Trial

Official title:
The Influence of Feeding Position on Pulmonary Morbidity in Young Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00248391
Other study ID # avitalbotlitis- HMO-CTIL
Secondary ID no grant meanwhi
Status Not yet recruiting
Phase N/A
First received November 3, 2005
Last updated October 25, 2007
Est. completion date January 2008

Study information
Verified date October 2006
Source Hadassah Medical Organization
Contact Avraham Avital, Prof
Phone 972-2-6777782
Email avital@hadassah.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

Supine feeding position is associated with serous otitis media. The hypothesis is that supine feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and recurrent pneumonia secondary to recurrent aspiration.

Description:

The aim of the study is to compare two "mother and child health clinic" stations with similar socioeconomic background. Mothers from the study station will be instructed to feed their children only in an upright position since birth. In the control station mothers will continue to feed their children as usual. Pulmonary morbidity will be evaluated prospectively through the computer system of the insurance companies.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2000
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 12 Months
Eligibility Inclusion Criteria:

- Newborn

- Mother's compliance

Exclusion Criteria:

- Bronchopulmonary dysplasia (BPD)

- Asthma

- Cystic fibrosis

- Heart disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Behavioral:
• upright feeding

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary pulmonary and ear-throat-nose morbidity
Primary medical costs measured every 3 months
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