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Thyroid Function in Late Preterm Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971555
First Posted: September 3, 2009
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Christiana Care Health Services
  Purpose

Transient hypothyroxinemia (TH) is a condition characterized by low levels of serum thyroxine (T4) and normal levels of thyroid stimulating hormone (TSH). TH in premature infants has been found to be related to severity of illness. T4 levels in very low birth weight infants born prematurely has been found to be inversely correlated to severity of illness. In very low birth weight infants, TH has been associated with poor outcomes. Little is known about thyroid function in late preterm infants.

Hypotheses:

  1. Ill late preterm infants will have lower total T4 levels than healthy late preterm infants.
  2. Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.
  3. Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.

Condition
Transient Hypothyroxinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery. [ Time Frame: First week of life ]

Biospecimen Retention:   Samples With DNA
Blood for total T4 and TSH testing will be done utilizing standardized filter paper used for the State of Delaware Newborn Screening Program.

Estimated Enrollment: 150
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Late preterm
Late preterm infants admitted to the NICU

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Late preterm infants
Criteria

Inclusion Criteria:

  • any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital

Exclusion Criteria:

  • outborn infants
  • infants with major congenital anomalies
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00971555


Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Renee M Behme, MD Christiana Hospital
Principal Investigator: David A Paul, MD Christiana Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David A. Paul, MD, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00971555     History of Changes
Other Study ID Numbers: CCC#29111
First Submitted: September 2, 2009
First Posted: September 3, 2009
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Christiana Care Health Services:
Transient Hypothyroxinemia
Late Preterm Infants
Total T4
TSH
Illness severity
NICU