An observational study in Thyroid Volume, Thyroid Ultrasound and Congenital Hypothyroidism, sponsored by IRCCS Ospedale San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 1 Day to 7 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by IRCCS Ospedale San Raffaele · Observational
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.
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.
27 studies on the registry are indexed under Congenital Hypothyroidism; 9 are open to participants now.
This study's planned enrollment of 400 is above the median of 241 across 14 observational studies indexed under Congenital Hypothyroidism.
Browse Congenital Hypothyroidism studies →IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.
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400 healthy term newborns, born between 37 to 42 weeks of gestational age
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy, born between 37 to 42 weeks of gestational age
Diagnostic Test: 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 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.
Thyroid volume
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.
Time frame: First week of life
Correlation between neonatal thyroid volume and neonatal anthropometric parameters
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.
Time frame: First week of life
Differences in thyroid volume between healthy and affected infants
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.
Time frame: First week of life
Correlation between neonatal thyroid volume and neonatal thyroid function
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.
Time frame: first week of life
Correlation between neonatal thyroid volume and maternal iodine status
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.
Time frame: first week of life
association between neonatal thyroid volume and ethnicity
Comparison of neonatal thyroid volume (mL, assessed by ultrasound) across different ethnic groups, expressed as mean differences or regression coefficients.
Time frame: first week of life
Association between neonatal thyroid volume and maternal pregnancy-related disorders
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.
Time frame: first week of life
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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