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Ultrasound and Functional Thyroid Evaluation

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ClinicalTrials.gov Identifier: NCT04208503
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Princess Anna Mazowiecka Hospital, Warsaw, Poland

Brief Summary:

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 provide references ranges of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results


Condition or disease Intervention/treatment
Thyroid Gland; Functional Disturbance Diagnostic Test: thyroid ultrasound

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 nomograms of the thyroid volume to aid in the comparative evaluation of infants with suspected thyroid disease. The sonography references ranges will give specialists possibility to identify a gland as normal, small or enlarged. Besides, the objective of the study is to provide references ranges of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid


Intervention Details:
  • Diagnostic Test: thyroid ultrasound
    After meeting enrolment criteria the thyroid ultrasound will be performed at 32 and 36 weeks of gestation, blood test for TSH and FT4 will be obtained at 14-21 day of life, at 32 and 36 weeks of gestation
    Other Names:
    • Diagnostic test
    • blood test for TSH and FT4 concentration


Primary Outcome Measures :
  1. changes in the ultrasound thyroid volume at 32 and 36 weeks of PCA in population of premature infants born 32 to define thyroid hormone reference ranges in the population of premature infants <32 [ Time Frame: at 32 and 36 weeks of PCA ]
    The thyroid volume

  2. changes in TSH references value in the population of premature infants born ≤32 [ Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA ]
    TSH - blood concentration

  3. changes in FT4 references value in the population of premature infants born ≤32 [ Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA ]
    FT4 - blood concentration


Secondary Outcome Measures :
  1. changes in the value distribution of thyroid hormones over time [ Time Frame: at 14-21 day of life, at 32 and 36 weeks of PCA ]
    comparison of results

  2. correlation of hormone concentration results with thyroid volume [ Time Frame: at 32 and 36 weeks of PCA ]
    Intervention time

  3. correlation of thyroid volume and hormone blood concentration with head circumference and body mass [ Time Frame: at 36 weeks of PCA ]
    Intervention time


Biospecimen Retention:   Samples Without DNA
1 ml blood for TSH and FT4 assessment


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208503


Contacts
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Contact: Aleksandra Mikolajczak, MD PhD +48 603 440 112 aamikolajczak@wp.pl
Contact: Renata Bokiniec, Prof MD P +48 22 59 66 155 r.bokiniec@wp.pl

Locations
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Poland
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University Recruiting
Warsaw, Poland, 00-315
Contact: Joanna Seliga-Siwecka, MD PhD    +48225966155    seliga.joanna@gmail.com   
Contact: Joanna Seliga-Siwecka         
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University Not yet recruiting
Warsaw, Poland
Sponsors and Collaborators
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Investigators
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Study Chair: Aleksandra Mikolajczak, MD PhD Princess Anna Mazowiecka
Publications:

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Responsible Party: Princess Anna Mazowiecka Hospital, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT04208503    
Other Study ID Numbers: 3/2019
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: January 2021-December 2021
Access Criteria: Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Princess Anna Mazowiecka Hospital, Warsaw, Poland:
thyroid volume
ultrasound
preterm infants
thyroid hormone
Additional relevant MeSH terms:
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Thyroid Diseases
Endocrine System Diseases