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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
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants |
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Inclusion Criteria:
Exclusion Criteria:
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We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Mikolajczak, MD PhD | Princess Anna Mazowiecka | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Recruiting | Warsaw | 00-315 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29406004 | Background | 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. | |
| 30529133 | 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. |
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All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.
January 2021-December 2021
Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D003955 | Diagnostic Tests, Routine |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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1 ml blood for TSH and FT4 assessment
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) | 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 | 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 | correlation of results with the body mass and the head circumference | at 32 and 36 weeks of PCA |
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Not yet recruiting | Warsaw | Poland |
| 12244277 | 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. |
| 24518164 | 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. |
| 30061589 | 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. |
| 25150803 | 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. |
| 18296580 | 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. |
| 27241963 | 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. |
| 17710960 | 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. |
| 27906195 | 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. |