Thyroid Function in Late Preterm Infants

Transient Hypothyroxinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971555
• Other study ID #: CCC#29111
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: March 22, 2011
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Transient Hypothyroxinemia

Locations

Country	Name	City	State
United States	Christiana Hospital	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.		First week of life	No