Thyroid Function in Late Preterm Infants

Completed

• Conditions: Transient Hypothyroxinemia

• Registration Number: NCT00971555
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.	First week of life

Trial Locations

Locations (1)

Christiana Hospital; 🇺🇸 Newark, Delaware, United States