NCT00971555

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. 1.Ill late preterm infants will have lower total T4 levels than healthy late preterm infants.
  2. 2.Total T4 and possibly TSH levels will be inversely correlated with short-term outcomes.
  3. 3.Late Preterm infants born by cesarean section will have lower T4 levels compared to those born by vaginal birth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

September 2, 2009

Last Update Submit

March 22, 2011

Conditions

Transient Hypothyroxinemia

Keywords

Transient HypothyroxinemiaLate Preterm InfantsTotal T4TSHIllness severityNICU

Outcome Measures

Primary Outcomes (1)

  • Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.

    First week of life

Study Arms (1)

Late preterm

Late preterm infants admitted to the NICU

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Late preterm infants

You may qualify if:

  • any infant born between 34 0/7 weeks and 36 6/7 weeks gestation born at Christiana Hospital

You may not qualify if:

  • outborn infants
  • infants with major congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Related Publications (1)

  • 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.

    PMID: 24259241DERIVED

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.

Study Officials

  • Renee M Behme, MD

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

  • David A Paul, MD

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

US(1)