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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
  Purpose

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.

Condition
Transient Hypothyroxinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thyroid Function in Late Preterm Infants in Relation to Severity of Illness

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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 ]

Biospecimen 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.


Estimated Enrollment: 150
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Late preterm
Late preterm infants admitted to the NICU

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Late preterm infants

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971555

Locations
United States, Delaware
Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Principal Investigator: Renee M Behme, MD Christiana Hospital
Principal Investigator: David A Paul, MD Christiana Hospital
  More Information

No publications provided by Christiana Care Health Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David A. Paul, MD, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00971555     History of Changes
Other Study ID Numbers: CCC#29111
Study First Received: September 2, 2009
Last Updated: March 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Transient Hypothyroxinemia
Late Preterm Infants
Total T4
TSH
Illness severity
NICU

ClinicalTrials.gov processed this record on November 25, 2014