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Thyroid Function in Late Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00971555
First received: September 2, 2009
Last updated: March 22, 2011
Last verified: March 2011

September 2, 2009
March 22, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00971555 on ClinicalTrials.gov 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.

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
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 1;27(5-6):425-30. doi: 10.1515/jpem-2013-0243. PubMed PMID: 24259241. .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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
Both
up to 7 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00971555
CCC#29111
No
David A. Paul, MD, Christiana Hospital
Christiana Care Health Services
Not Provided
Principal Investigator: Renee M Behme, MD Christiana Hospital
Principal Investigator: David A Paul, MD Christiana Hospital
Christiana Care Health Services
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP