Thyroid Function in Late Preterm Infants | NCT00971555

Studies
Thyroid Function in Late Preterm Infants

NCT00971555

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Mar 23, 2011Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Transient Hypothyroxinemia

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Sep 2, 2009

First Submission Date that Met QC Criteria

Sep 2, 2009

First Posted Date

Sep 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2011

Last Update Posted Date

Mar 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

150Estimated

Label	Type	Description	Intervention Names
Late preterm		Late preterm infants admitted to the NICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of total T4 and TSH with gestational age, birth weight, and mode of delivery.		First week of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

Late preterm infants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Renee M Behme, MD	Christiana Hospital	Principal Investigator
David A Paul, MD	Christiana Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Hospital		Newark	Delaware	19718	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24259241	Derived	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.