Ultrasound and Functional Thyroid Evaluation

NCT04208503 | Unknown DMC

• 1 other identifier: 3/2019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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 determine values of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results

Conditions

Thyroid; Gland; Functional Disturbance

Keywords

thyroid volume; ultrasound; preterm infants; thyroid hormone

Outcome Measures

Primary Outcomes (4)

• Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation

  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

  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)

  The thyroid volume

  at 32 and 36 weeks of PCA

• Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume

  comparison of values of FT4, TSH and thyroid volume

  at 32 and 36 weeks of PCA

Secondary Outcomes (5)

• Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants

  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

  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)

  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

  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

  at 32 and 36 weeks of PCA

Interventions

thyroid ultrasound DIAGNOSTIC_TEST

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

Also known as: Diagnostic test, blood test for TSH and FT4 concentration

Eligibility Criteria

• Age: 1 Week - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Anna Mazowiecka Hospital, Warsaw, Poland: lead

Study Sites (2)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, 00-315, Poland

RECRUITING

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University

Warsaw, Poland

NOT YET RECRUITING

Related Publications (10)

• Chaudhari M, Slaughter JL. Thyroid Function in the Neonatal Intensive Care Unit. Clin Perinatol. 2018 Mar;45(1):19-30. doi: 10.1016/j.clp.2017.10.005. Epub 2017 Dec 13.

  PMID: 29406004 BACKGROUND

• McGrath N, Hawkes CP, Mayne P, Murphy NP. Optimal Timing of Repeat Newborn Screening for Congenital Hypothyroidism in Preterm Infants to Detect Delayed Thyroid-Stimulating Hormone Elevation. J Pediatr. 2019 Feb;205:77-82. doi: 10.1016/j.jpeds.2018.09.044. Epub 2018 Oct 24.

  PMID: 30529133 BACKGROUND

• Radetti G, Zavallone A, Gentili L, Beck-Peccoz P, Bona G. Foetal and neonatal thyroid disorders. Minerva Pediatr. 2002 Oct;54(5):383-400. English, Italian.

  PMID: 12244277 BACKGROUND

• Vigone MC, Caiulo S, Di Frenna M, Ghirardello S, Corbetta C, Mosca F, Weber G. Evolution of thyroid function in preterm infants detected by screening for congenital hypothyroidism. J Pediatr. 2014 Jun;164(6):1296-302. doi: 10.1016/j.jpeds.2013.12.048. Epub 2014 Feb 8.

  PMID: 24518164 BACKGROUND

• Khan SS, Hong-McAtee I, Kriss VM, Stevens S, Crawford T, Hanna M, Bada H, Desai N. Thyroid gland volumes in premature infants using serial ultrasounds. J Perinatol. 2018 Oct;38(10):1353-1358. doi: 10.1038/s41372-018-0149-0. Epub 2018 Jul 30.

  PMID: 30061589 BACKGROUND

• Oh KW, Koo MS, Park HW, Chung ML, Kim MH, Lim G. Establishing a reference range for triiodothyronine levels in preterm infants. Early Hum Dev. 2014 Oct;90(10):621-4. doi: 10.1016/j.earlhumdev.2014.07.012. Epub 2014 Aug 24.

  PMID: 25150803 BACKGROUND

• Kurtoglu S, Ozturk MA, Koklu E, Gunes T, Akcakus M, Yikilmaz A, Buyukkayhan D, Hatipoglu N. Thyroid volumes in newborns of different gestational ages: normative data. Arch Dis Child Fetal Neonatal Ed. 2008 Mar;93(2):F171. doi: 10.1136/adc.2007.130211. No abstract available.

  PMID: 18296580 BACKGROUND

• Goldis M, Waldman L, Marginean O, Rosenberg HK, Rapaport R. Thyroid Imaging in Infants. Endocrinol Metab Clin North Am. 2016 Jun;45(2):255-66. doi: 10.1016/j.ecl.2016.02.005.

  PMID: 27241963 BACKGROUND

• Knobel RB. Thyroid hormone levels in term and preterm neonates. Neonatal Netw. 2007 Jul-Aug;26(4):253-9. doi: 10.1891/0730-0832.26.4.253.

  PMID: 17710960 BACKGROUND

• Kaluarachchi DC, Colaizy TT, Pesce LM, Tansey M, Klein JM. Congenital hypothyroidism with delayed thyroid-stimulating hormone elevation in premature infants born at less than 30 weeks gestation. J Perinatol. 2017 Mar;37(3):277-282. doi: 10.1038/jp.2016.213. Epub 2016 Dec 1.

  PMID: 27906195 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

1 ml blood for TSH and FT4 assessment

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Diagnostic Tests, Routine; Hematologic Tests

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Aleksandra Mikolajczak, MD PhD

  Princess Anna Mazowiecka

  STUDY CHAIR

Central Study Contacts

Aleksandra Mikolajczak, MD PhD

CONTACT

+48 603 440 112; aamikolajczak@wp.pl

Renata Bokiniec, Prof MD P

CONTACT

+48 22 59 66 155; r.bokiniec@wp.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 23, 2019
• Study Start: December 19, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

PL (2)