Thyroid Function in Late Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00971555
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : March 23, 2011
Information provided by:
Christiana Care Health Services

September 2, 2009
September 3, 2009
March 23, 2011
September 2009
January 2011   (Final data collection date for primary outcome measure)
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery. [ Time Frame: First week of life ]
Same as current
Complete list of historical versions of study NCT00971555 on Archive Site
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Thyroid Function in Late Preterm Infants
Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

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.


  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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Blood for total T4 and TSH testing will be done utilizing standardized filter paper used for the State of Delaware Newborn Screening Program.
Non-Probability Sample
Late preterm infants
Transient Hypothyroxinemia
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Late preterm
Late preterm infants admitted to the NICU
Behme RM, Mackley AB, Bartoshesky L, Paul DA. Thyroid function in late preterm infants in relation to mode of delivery and respiratory support. J Pediatr Endocrinol Metab. 2014 May;27(5-6):425-30. doi: 10.1515/jpem-2013-0243.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 7 Days   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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David A. Paul, MD, Christiana Hospital
Christiana Care Health Services
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Principal Investigator: Renee M Behme, MD Christiana Hospital
Principal Investigator: David A Paul, MD Christiana Hospital
Christiana Care Health Services
March 2011