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Predictors of Cord Blood Immunoglobin E (IgE) Levels

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT00902096
First received: May 13, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition
Atopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:
  • cord blood IgE [ Time Frame: at birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cord blood cytokines or other mediators [ Time Frame: at birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: April 2009
Groups/Cohorts
Prenatal factors
Prenatal factors to predict cord blood IgE

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
hospital and primary care clinic based study
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902096

Locations
Taiwan
Min-Sheng General Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Chien-Han Chen, MD Min-Sheng General Hospital
  More Information

Responsible Party: Chien-Han Chen, Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT00902096     History of Changes
Other Study ID Numbers: 2009008 
Study First Received: May 13, 2009
Last Updated: May 13, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Min-Sheng General Hospital:
cord blood
IgE
prenatal
predictor

ClinicalTrials.gov processed this record on December 05, 2016