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Thyroid Function in Late Preterm Infants

Sponsor
Christiana Care Health Services (Other)
Overall Status
Completed
CT.gov ID
NCT00971555
Collaborator
(none)
150
Enrollment
1
Location
16
Duration (Months)
9.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Thyroid Function in Late Preterm Infants in Relation to Severity of Illness
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Late preterm

    Late preterm infants admitted to the NICU

    Outcome Measures

    Primary Outcome Measures

    1. Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery. [First week of life]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 7 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00971555
    Other Study ID Numbers:
    • CCC#29111
    First Posted:
    Sep 3, 2009
    Last Update Posted:
    Mar 23, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    Transient Hypothyroxinemia
    Late Preterm Infants
    Total T4
    TSH
    Illness severity
    NICU
    Additional relevant MeSH terms:
    Premature Birth

    Study Results

    No Results Posted as of Mar 23, 2011