- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07579988
Ultrasound Measurement of Thyroid Volume in Term Newborns (NEOTIR)
5 мая 2026 г. обновлено: Vigone Maria Cristina, IRCCS Ospedale San Raffaele
Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study
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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
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.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
400
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Maria Cristina Vigone, MD
- Номер телефона: +39 0226432625
- Электронная почта: vigone.mariacristina@hsr.it
Места учебы
-
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Italy
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Milan, Italy, Италия, 20132
- IRCCS Ospedale San Raffaele
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Да
Метод выборки
Невероятностная выборка
Исследуемая популяция
400 healthy term newborns, born between 37 to 42 weeks of gestational age
Описание
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Healthy term newborns
Healthy, born between 37 to 42 weeks of gestational age
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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 scanner.
A generous amount of coupling gel is applied to the transducer surface, which is placed midline on the neck of the infant.
The examination of each lobe is performed in both longitudinal and transverse projections.
During the examination, the neonate is in the supine position with slight extension of the neck, while sucking on an assistant's gloved finger with glucose drops.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Thyroid volume
Временное ограничение: First week of life
|
Establish reference values for normality for thyroid volume in term newborns.
Measurement of the anteroposterior, mediolateral, and craniocaudal diameters (cm) of both thyroid lobes.
Calculation of thyroid volume (ml) using the ellipsoid formula.
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First week of life
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correlation between neonatal thyroid volume and neonatal anthropometric parameters
Временное ограничение: First week of life
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Correlation between neonatal thyroid volume (measured in mL by ultrasound) and neonatal weight (g), length (cm), and gestational age (weeks), expressed as Pearson or Spearman correlation coefficients as appropriate.
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First week of life
|
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Differences in thyroid volume between healthy and affected infants
Временное ограничение: First week of life
|
To use the data collected from healthy subjects as a reference for comparison with data from newborns affected by thyroid disorders.
To analyze statistically significant volumetric differences in thyroid volume between healthy and affected infants, with the aim of developing earlier diagnostic tools or gaining a better understanding of the mechanisms underlying neonatal thyroid disorders.
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First week of life
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Correlation between neonatal thyroid volume and neonatal thyroid function
Временное ограничение: first week of life
|
Correlation between neonatal thyroid volume (mL, assessed by ultrasound) and serum TSH (mU/L) and FT4 (pmol/L), measured using standard laboratory assays, expressed as Pearson or Spearman correlation coefficients.
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first week of life
|
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Correlation between neonatal thyroid volume and maternal iodine status
Временное ограничение: first week of life
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Correlation between neonatal thyroid volume (mL, assessed by ultrasound) and maternal urinary iodine concentration (µg/L), measured using standard urinary iodine assays, expressed as Pearson or Spearman correlation coefficients.
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first week of life
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association between neonatal thyroid volume and ethnicity
Временное ограничение: first week of life
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Comparison of neonatal thyroid volume (mL, assessed by ultrasound) across different ethnic groups, expressed as mean differences or regression coefficients.
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first week of life
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Association between neonatal thyroid volume and maternal pregnancy-related disorders
Временное ограничение: first week of life
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Comparison of neonatal thyroid volume (mL, assessed by ultrasound) between groups defined by the presence or absence of maternal pregnancy-related disorders (e.g., thyroid disease, gestational diabetes, hypertension), expressed as mean differences or regression coefficients.
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first week of life
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Vade A, Gottschalk ME, Yetter EM, Subbaiah P. Sonographic measurements of the neonatal thyroid gland. J Ultrasound Med. 1997 Jun;16(6):395-9. doi: 10.7863/jum.1997.16.6.395.
- 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.
- Perry RJ, Hollman AS, Wood AM, Donaldson MD. Ultrasound of the thyroid gland in the newborn: normative data. Arch Dis Child Fetal Neonatal Ed. 2002 Nov;87(3):F209-11. doi: 10.1136/fn.87.3.f209.
- Mikolajczak A, Borszewska-Kornacka MK, Romejko-Wolniewicz E, Bokiniec R. Comparison of the offspring ultrasound thyroid volume in hypothyroid mothers treated with different levothyroxine doses: A cohort study. Adv Med Sci. 2020 Sep;65(2):332-337. doi: 10.1016/j.advms.2020.05.004. Epub 2020 Jun 21.
- Leger J, Olivieri A, Donaldson M, Torresani T, Krude H, van Vliet G, Polak M, Butler G; ESPE-PES-SLEP-JSPE-APEG-APPES-ISPAE; Congenital Hypothyroidism Consensus Conference Group. European Society for Paediatric Endocrinology consensus guidelines on screening, diagnosis, and management of congenital hypothyroidism. J Clin Endocrinol Metab. 2014 Feb;99(2):363-84. doi: 10.1210/jc.2013-1891. Epub 2014 Jan 21.
- Kreisner E, Camargo-Neto E, Maia CR, Gross JL. Accuracy of ultrasonography to establish the diagnosis and aetiology of permanent primary congenital hypothyroidism. Clin Endocrinol (Oxf). 2003 Sep;59(3):361-5. doi: 10.1046/j.1365-2265.2003.01856.x.
- van Trotsenburg P, Stoupa A, Leger J, Rohrer T, Peters C, Fugazzola L, Cassio A, Heinrichs C, Beauloye V, Pohlenz J, Rodien P, Coutant R, Szinnai G, Murray P, Bartes B, Luton D, Salerno M, de Sanctis L, Vigone M, Krude H, Persani L, Polak M. Congenital Hypothyroidism: A 2020-2021 Consensus Guidelines Update-An ENDO-European Reference Network Initiative Endorsed by the European Society for Pediatric Endocrinology and the European Society for Endocrinology. Thyroid. 2021 Mar;31(3):387-419. doi: 10.1089/thy.2020.0333.
- Laurberg P. Thyroid function: Thyroid hormones, iodine and the brain-an important concern. Nat Rev Endocrinol. 2009 Sep;5(9):475-6. doi: 10.1038/nrendo.2009.155.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 мая 2026 г.
Первичное завершение (Оцененный)
1 мая 2027 г.
Завершение исследования (Оцененный)
1 мая 2027 г.
Даты регистрации исследования
Первый отправленный
28 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
5 мая 2026 г.
Первый опубликованный (Действительный)
12 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
5 мая 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Заболевания костей
- Заболевания опорно-двигательного аппарата
- Генетические заболевания, врожденные
- Болезни костей, эндокринные
- Болезни костей, развитие
- Карликовость
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Гипотиреоз
- Заболевания щитовидной железы
- Врожденный гипотиреоз
Другие идентификационные номера исследования
- NEOTIR
Планирование данных отдельных участников (IPD)
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НЕ РЕШЕНО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .