Predictors of Cord Blood Immunoglobin E (IgE) Levels | NCT00902096

Studies
Predictors of Cord Blood Immunoglobin E (IgE) Levels

NCT00902096

Sponsor

Min-Sheng General Hospital

Status

Unknown status

Last Update Posted

May 14, 2009Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Atopy

Interventions

Not provided

Countries

Taiwan

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

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 13, 2009

First Submission Date that Met QC Criteria

May 13, 2009

First Posted Date

May 14, 2009Estimated

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

May 13, 2009

Last Update Posted Date

May 14, 2009Estimated

Description Module

Brief Summary

Background: Increased total serum IgE levels are a common characteristic of atopic diseases. Increased cord blood IgE levels, in conjunction with a family history of atopy, are associated with the development of allergic diseases in children. However, little is known about predictors of cord blood IgE levels.

Objective: The aim of our study was to identify predictors of cord blood IgE levels in an ongoing large birth cohort of infants with or without a family history of atopy.

Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord blood was also collected when the child was born. Maternal and cord blood was measured for IgE levels and cytokines. Questionnaires were administered after birth of the infant.

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

800Estimated

Label	Type	Description	Intervention Names
Prenatal factors		Prenatal factors to predict cord blood IgE

Measure	Description	Time Frame
cord blood IgE		at birth

Measure	Description	Time Frame
Cord blood cytokines or other mediators		at birth

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers in pregnancy 18 years of age or older, AND
Mothers able to speak Chinese.

Exclusion Criteria:

Infant delivered at less than 36 weeks' gestation,
Infant with Apgar score in 5 minutes after birth < 7,
Infant with a major congenital anomaly, OR
Infant admitted to an intensive care unit.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

hospital and primary care clinic based study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chien-Han Chen, MD	Contact	886-3-3179599	2004	chinsword@yahoo.com.tw

Overall Officials

Name	Affiliation	Role
Chien-Han Chen, MD	Min-Sheng General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Min-Sheng General Hospital	Recruiting	Taoyuan			Taiwan