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Набор скоро начнётся NCT07579988

Ultrasound Measurement of Thyroid Volume in Term Newborns

Наблюдательное Thyroid Volume Thyroid Ultrasound Congenital Hypothyroidism Healthy Newborns

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Thyroid ultrasound.
Кому может быть актуально
Состояния в реестре: Thyroid Volume, Thyroid Ultrasound, Congenital Hypothyroidism, Healthy Newborns. Базовые параметры: 1 Day — 7 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study

Обзор

First, to date, no data are available on the thyroid volume of full-term newborns in Italy, making it essential to conduct studies to establish reference values for normality. This allows these values to be correlated with maternal and fetal variability, providing a scientific basis for better understanding thyroid development in the first days of life. Thyroid ultrasound is useful for supplementing newborn screening for congenital hypothyroidism, helping to identify early abnormalities. Furthermore, thyroid volume is a sensitive indicator of iodine intake, essential for assessing the population's iodine nutritional status. It is equally valuable for studying and monitoring the effects of maternal and environmental factors, for which thyroid volume itself serves as a marker. Having normal values allows for a more precise comparison and contextualization of data from children with pathologies, who undergo ultrasound for pathological screening. In summary, these regulatory references improve the diagnosis, prevention, and management of neonatal thyroid dysfunction, contributing to a more informed public health.

Подробное описание

The thyroid is a fundamental endocrine gland that regulates metabolism throughout the life cycle. Thyroid's function is particularly crucial in fetuses, newborns, and children, as thyroid hormones play a key role in the development of the central nervous system. A deficiency of thyroid hormones in childbearing age women due to untreated hypothyroidism, autoimmune disorders or iodine deficiency poses a threat to both fertility and pregnancy progression and can negatively impact fetal and neonatal neurological outcomes later in life. Since the introduction of neonatal TSH- screening method the prognosis of newborn with congenital hypothyroidism has significantly improved due to early start of levothyroxine treatment. The findings of reduced or increased thyroid size in newborn with TSH elevation can support the need for further investigation such as genetic analysis. For this reason, having normative data of thyroid volume is fundamental in newborn population. According to the current guidelines for congenital hypothyroidism, the primary imaging techniques for evaluating neonatal thyroid include ultrasound and radionuclide scintigraphy. Ultrasound is the preferred modality due to its non-invasive nature and ability to provide detailed information about the gland's structure, size, position, vascularization, and echogenicity. Thyroid volume is tightly regulated during fetal development, and variations in size may indicate pathological maternal and neonatal dysfunctions. Therefore, thyroid volume measurement is a crucial indicator for monitoring the gland's development and function in newborns and is strongly associated to environmental factor such as iodine status and maternal factors. International studies conducted in countries with different iodine status and national salt iodization programs (Poland, Germany, Belgium, Turkey, United Kidgdom, United States China, Brazil) have shown significant variations in average thyroid volume values in euthyroid term newborn ranging from 0.47 in the Unites States to and 1.62 ml in the United Kingdom. These findings highlight the importance of geography and iodine supplementation in determining neonatal thyroid volume. Ultrasound of the thyroid gland was generally recorded during the first three weeks of life. However, no reference data are currently available for Italian newborns. Italy is considered an iodine sufficient area but there is an increased risk of deficiency during pregnancy. Establishing specific reference values of newborn thyroid volume for the Italian population is therefore necessary. In addition to the geographical region of origin, several maternal factors may influence neonatal thyroid volume, including levothyroxine intake in cases of hypothyroidism, nutritional iodine supply/intake, use of medications/disinfectants containing iodine, gestational diabetes and smoking during pregnancy. One study found a negative correlation between high maternal levothyroxine doses and neonatal thyroid volume. Although this correlation is weak, multivariate logistic models confirmed the impact of maternal therapy on neonatal thyroid volume. Excess maternal thyroid hormones can suppress fetal TSH secretion, limiting follicular cell proliferation, leading to a reduced neonatal thyroid volume. Studies about the association between gestational diabetes and thyroid neonatal volume reported difference results. Smoking during pregnancy has also been associated with variations in neonatal thyroid volume. Studies on adults have shown a 25% increase in thyroid volume in smokers compared to non-smokers. The high prevalence of smoking among young women in certain regions could explain an increased neonatal thyroid volume. This study is essential for establishing national reference values for thyroid volume in healthy term and preterm Italian newborns, addressing a gap in the available data. Understanding geographical differences, maternal influences, and the newborn characteristics of preterm newborns will improve the monitoring and management of neonatal thyroid conditions, with potential implications for public and neonatal health.

Вмешательства

  • Диагностический тест Thyroid ultrasound
    Thyroid Ultrasound is a safe method because it does not involve ionizing radiation, is non-invasive and painless, takes only a few minutes, and does not cause discomfort. The Ultrasound machine is the Philips EPIQ 5 system (Philips Healthcare, Eindhoven, the Netherlands) with CE certification. The examination is conducted with high-frequency probes (linear hockey stick L12-20 MHz). All thyroid gland scans and measurements are performed by two trained observers at the bedside using a portable sca

Первичные конечные точки

  • Thyroid volume [Срок оценки: First week of life]
Вторичные конечные точки (6)
  • Correlation between neonatal thyroid volume and neonatal anthropometric parameters [Срок оценки: First week of life]
  • Differences in thyroid volume between healthy and affected infants [Срок оценки: First week of life]
  • Correlation between neonatal thyroid volume and neonatal thyroid function [Срок оценки: first week of life]
  • Correlation between neonatal thyroid volume and maternal iodine status [Срок оценки: first week of life]
  • association between neonatal thyroid volume and ethnicity [Срок оценки: first week of life]
  • Association between neonatal thyroid volume and maternal pregnancy-related disorders [Срок оценки: first week of life]

Критерии участия

Критерии включения

  • Healthy full term newborns (born between 37 and 42 weeks of gestation, with no antennal issue or complications at birth)
  • Consent obtained by parent(s) or legal guardian(s)

Критерии исключения

  • Congenital malformations
  • TSH abnormalities in neonatal screening
  • Pregnancy not carried out in Italy, due to different iodine status
  • Inability or unwillingness of the parent(s) or legal guardian(s) to provide informed consent or to comply with study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 1 центр
  • IRCCS Ospedale San Raffaele — Milan

Публикации

  • Koksal N, Akturk B, Saglam H, Yazici Z, Cetinkaya M. Reference values for neonatal thyroid volumes in a moderately iodine-deficient area. J Endocrinol Invest. 2008 Jul;31(7):642-6. doi: 10.1007/BF03345617. PMID 18787384
  • Croce L, Chiovato L, Tonacchera M, Petrosino E, Tanda ML, Moleti M, Magri F, Olivieri A, Pearce EN, Rotondi M. Iodine status and supplementation in pregnancy: an overview of the evidence provided by meta-analyses. Rev Endocr Metab Disord. 2023 Apr;24(2):241-250. doi: 10.1007/s11154-022-09760-7. Epub 2022 Oct 13. PMID 36227457
  • Olivieri A, Trimarchi F, Vitti P. Global iodine nutrition 2020: Italy is an iodine sufficient country. J Endocrinol Invest. 2020 Nov;43(11):1671-1672. doi: 10.1007/s40618-020-01402-6. Epub 2020 Aug 31. No abstract available. PMID 32865777
  • Yao D, He X, Yang RL, Jiang GP, Xu YH, Zou CC, Zhao ZY. Sonographic measurement of thyroid volumes in healthy Chinese infants aged 0 to 12 months. J Ultrasound Med. 2011 Jul;30(7):895-8. doi: 10.7863/jum.2011.30.7.895. PMID 21705721
  • Tuzcu G, Deveci Sevim R, Gok M, Anik A, Anik A. Normative Values for Thyroid Volume and Tracheal Index in Healthy Turkish Newborns in an Iodine Sufficient Region. J Clin Res Pediatr Endocrinol. 2025 Aug 22;17(3):256-262. doi: 10.4274/jcrpe.galenos.2024.2024-7-20. Epub 2024 Nov 13. PMID 39535106
  • Ozdikici M. Ultrasound Measurement of Thyroid Volume in Healthy Children. Ultrasound Q. 2025 Feb 20;41(1):e00711. doi: 10.1097/RUQ.0000000000000711. eCollection 2025 Mar 1. PMID 39982374
  • Mikolajczak A, Borszewska-Kornacka MK, Bokiniec R. Sonographic Reference Ranges for the Thyroid Gland in Euthyroid Term Newborns. Am J Perinatol. 2015 Nov;32(13):1257-62. doi: 10.1055/s-0035-1552937. Epub 2015 May 29. PMID 26023906
  • Kurtoglu S, Akcakus M, Kocaoglu C, Gunes T, Budak N, Atabek ME, Karakucuk I, Delange F. Iodine status remains critical in mother and infant in Central Anatolia (Kayseri) of Turkey. Eur J Nutr. 2004 Oct;43(5):297-303. doi: 10.1007/s00394-004-0474-2. Epub 2004 Jan 30. PMID 15309449

Идентификаторы

NCT: NCT07579988 · NEOTIR

Первоисточники (государственные реестры)

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