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Clinical Trials/NCT00971555
NCT00971555
Completed
Not Applicable

Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Christiana Care Health Services1 site in 1 country150 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transient Hypothyroxinemia
Sponsor
Christiana Care Health Services
Enrollment
150
Locations
1
Primary Endpoint
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
September 2009
End Date
January 2011
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.

Time Frame: First week of life

Study Sites (1)

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