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
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