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Thyroid Function in Late Preterm Infants

Information source: Christiana Care Health Services
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transient Hypothyroxinemia

Phase: N/A

Status: Recruiting

Sponsored by: Christiana Care Health Services

Official(s) and/or principal investigator(s):
Renee M Behme, MD, Principal Investigator, Affiliation: Christiana Hospital
David A Paul, MD, Principal Investigator, Affiliation: Christiana Hospital

Overall contact:
Renee M Behme, MD, Phone: 302-733-2410, Email: Renee.behme@jeffersonhospital.org

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.

Clinical Details

Official title: Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Eligibility

Minimum age: N/A. Maximum age: 7 Days. Gender(s): Both.

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

Locations and Contacts

Renee M Behme, MD, Phone: 302-733-2410, Email: Renee.behme@jeffersonhospital.org

Christiana Hospital, Newark, Delaware 19718, United States; Recruiting
Amy B Mackley, MSN, RNC, Phone: 302-733-2153, Email: amackley@christianacare.org
David A Paul, MD, Sub-Investigator
Renee M Behme, MD, Principal Investigator
Louis Bartoshesky, MD, Sub-Investigator
Amy B Mackley, MSN, RNC, Sub-Investigator
Additional Information

Starting date: September 2009
Last updated: September 22, 2010

Page last updated: October 04, 2010

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