Allergy and Ashthma in Children Who Were Fed Supplemented... | NCT01205659

Studies
Allergy and Ashthma in Children Who Were Fed Supplemented Infant Formula

NCT01205659

Sponsor

Mead Johnson Nutrition

Status

Completed

Last Update Posted

Sep 20, 2010Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Allergy and Asthma

Interventions

Not provided

Countries

United States

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

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 17, 2010

First Submission Date that Met QC Criteria

Sep 17, 2010

First Posted Date

Sep 20, 2010Estimated

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

Sep 17, 2010

Last Update Posted Date

Sep 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest .

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of asthma and allergy related diagnosis in medical records for ages 3 - 7 years

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of Serious Adverse Events in medical records
Long-term growth

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children who participated in randomized trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Children who participated in randomizaed trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Retina Foundation of The Southwest		Dallas	Texas	75231	United States

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D001249	Asthma

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive

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Browse Branches

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