The Influence of Feeding Position on Pulmonary Morbidity... | NCT00248391

Studies
The Influence of Feeding Position on Pulmonary Morbidity in Young Children

NCT00248391

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Oct 26, 2007Estimated

Enrollment

2,000Estimated

Phase

Not Applicable

Conditions

Pulmonary Diseases
Tonsillar Hypertrophy
Otitis Media
Dental Caries

Interventions

upright feeding

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
no grant meanwhile

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Jan 2008Estimated

First Submitted Date

Nov 3, 2005

First Submission Date that Met QC Criteria

Nov 3, 2005

First Posted Date

Nov 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2007

Last Update Posted Date

Oct 26, 2007Estimated

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
upright feeding	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pulmonary and ear-throat-nose morbidity
medical costs		measured every 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newborn
Mother's compliance

Exclusion Criteria:

Bronchopulmonary dysplasia (BPD)
Asthma
Cystic fibrosis
Heart disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Avraham Avital, Prof	Contact	972-2-6777782		avital@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Avraham Avital, Prof	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem		P.P.Box 12000	Israel

Condition Browse Module

MeSH Terms

ID	Term
D008171	Lung Diseases
D010033	Otitis Media
D003731	Dental Caries
D008192	Deception
D011014	Pneumonia
D012135	Respiratory Sounds
D010031	Otitis

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D017001	Tooth Demineralization

Browse Leaves

Not provided

Browse Branches

Not provided