Ultrasound and Functional Thyroid Evaluation

August 8, 2021 updated by: Princess Anna Mazowiecka Hospital, Warsaw, Poland

Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation

Thyroid disorders are most commonly concomitant with prematurity and still remains a controversial topic. The incidence of a temporary form of hypothyroidism among preterm neonates is higher than in the general population. Transient prematurity hypothyroxinemia is defined as a temporary reduction in FT4 values without increase in TSH values. Currently, there is no consensus about normal thyrotropine (TSH) and free thyroxine (FT4) values in preterm infants.

The aim of this study is to determine the volume of the thyroid gland in preterm infants born between 24 and 32 weeks of gestation inborn or admitted to the unit within 14 days from birth and compare it with the results of TSH and FT4 blood concentration. Besides, the objective of the study is to determine values of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid disorders are most commonly concomitant with prematurity and still remains a controversial topic. Preterm infants are susceptible to thyroid disorders due to many reasons including immaturity of hypothalamopituitary-thyroid axis, non-thyroidal illness, impaired synthesis and metabolism of thyroid hormones, medication administration like dopamine, steroids, caffeine.The incidence of a temporary form of hypothyroidism among preterm neonates is higher than in the general population. Transient prematurity hypothyroxinemia is defined as a temporary reduction in FT4 values without increase in TSH values. It is a diagnostic challenge in order to differentiate it from thyroid disfunction in the critically ill patient. Currently, there is no consensus about normal thyrotropine (TSH) and free thyroxine (FT4) values in preterm infants. Given the delayed appearance of TSH value increase in preterm newborns additional thyroid evaluation methods are sought. We believe the thyroid ultrasound might prove helpful.

The aim of this study is to determine the volume of the thyroid gland in preterm infants born between 24 and 32 weeks of gestation inborn or admitted to the unit within 14 days from birth and compare it with the results of TSH and FT4 blood concentration. We will performed the thyroid ultrasound to estimate the thyroid volume to aid in the comparative evaluation of infants with suspected thyroid disease. The value of sonography thyroid volume will give specialists possibility to identify a gland as normal, small or enlarged. Besides, the objective of the study is to determine value of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Aleksandra Mikolajczak, MD PhD
  • Phone Number: +48 603 440 112
  • Email: aamikolajczak@wp.pl

Study Locations

  • Poland
      • Warsaw, Poland, 00-315
        • Recruiting
        • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
      • Warsaw, Poland
        • Not yet recruiting
        • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.

Description

Inclusion Criteria:

  • preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
  • in born or admitted to the unit within one week from birth
  • randomization within 7 days from birth
  • parental consent

Exclusion Criteria:

  • preterm delivery <23 weeks of gestation or > 32 weeks (estimated by ultrasound)
  • major congenital abnormalities
  • no parental consent
  • medications used after birth: steroids, vasopressors (up to 12 hours after end of treatment)
  • positive thyroid stimulating antibodies (TSAb) in the mother
  • mothers with thyroid disease treated with antythyroid drugs
  • mothers treated with amiodarone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation
Time Frame: 14-21 days of life, at 32 and 36 weeks of PCA
FT4 and TSH - blood concentration
14-21 days of life, at 32 and 36 weeks of PCA
Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation
Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA
FT4 and TSH - blood concentration
at 14-21 day of life, at 32 and 36 weeks of PCA
Determination of ultrasound thyroid volume in both groups of preterm infants (i.e., those born at 24-28 weeks of gestation and those born at 29-32 weeks of gestation)
Time Frame: at 32 and 36 weeks of PCA
The thyroid volume
at 32 and 36 weeks of PCA
Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume
Time Frame: at 32 and 36 weeks of PCA
comparison of values of FT4, TSH and thyroid volume
at 32 and 36 weeks of PCA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants
Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA
comparison of results
at 14-21 day of life, at 32 and 36 weeks of PCA
Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants
Time Frame: 14-21 days of life, at 32 and 36 weeks of PCA
comparison of results
14-21 days of life, at 32 and 36 weeks of PCA
Analysis of TSH values over time (to determine the optimal time for TSH measurement)
Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA
Intervention time
at 14-21 day of life, at 32 and 36 weeks of PCA
Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants
Time Frame: at 32 and 36 weeks of PCA
comparison of results
at 32 and 36 weeks of PCA
Evaluation of the correlation between thyroid volume and circulating thyroid hormone concentrations with the head circumference and body mass at 32 and 36 weeks of PCA
Time Frame: at 32 and 36 weeks of PCA
correlation of results with the body mass and the head circumference
at 32 and 36 weeks of PCA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Investigators

  • Study Chair: Aleksandra Mikolajczak, MD PhD, Princess Anna Mazowiecka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 8, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.

IPD Sharing Time Frame

January 2021-December 2021

IPD Sharing Access Criteria

Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid

Clinical Trials on thyroid ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe