Ultrasound and Functional Thyroid Evaluation

Thyroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04208503
• Other study ID #: 3/2019
• Status: Recruiting
• Start date: December 19, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: Aleksandra Mikolajczak, MD PhD
• Phone: +48 603 440 112
• Email: aamikolajczak[@]wp.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Gland; Functional Disturbance
• Thyroid
• Thyroid Diseases

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Knobel RB. Thyroid hormone levels in term and preterm neonates. Neonatal Netw. 2007 Jul-Aug;26(4):253-9. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

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