NCT00902096

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
Last Updated

May 14, 2009

Status Verified

May 1, 2009

First QC Date

May 13, 2009

Last Update Submit

May 13, 2009

Conditions

Atopy

Keywords

cord bloodIgEprenatalpredictor

Outcome Measures

Primary Outcomes (1)

  • cord blood IgE

    at birth

Secondary Outcomes (1)

  • Cord blood cytokines or other mediators

    at birth

Study Arms (1)

Prenatal factors

Prenatal factors to predict cord blood IgE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital and primary care clinic based study

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min-Sheng General Hospital

Taoyuan District, Taiwan

RECRUITING

Study Officials

  • Chien-Han Chen, MD

    Min-Sheng General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Han Chen, MD

CONTACT

886-3-3179599chinsword@yahoo.com.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 14, 2009

Study Start

April 1, 2009

Last Updated

May 14, 2009

Record last verified: 2009-05

Locations

TW(1)