Thyroid VolumeNEOTIRNCT07579988
Ultrasound Measurement of Thyroid Volume in Term Newborns
An observational study of Thyroid Volume and Thyroid Ultrasound, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Thyroid Volume, Thyroid Ultrasound, Congenital Hypothyroidism
- What is being tested?
- Thyroid ultrasound
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2026to 1 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 400 healthy term newborns, born between 37 to 42 weeks of gestational age
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Thyroid ultrasound
- Keywords
- thyroid, thyroid volume, reference values thyroid ultrasound, newborn
- Medical subject headings
- Congenital Hypothyroidism, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid ultrasoundDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy term newborns | Healthy, born between 37 to 42 weeks of gestational age Receives: Diagnostic Test: Thyroid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First week of life
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: first week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Thyroid VolumeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- IRCCS Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vigone Maria Cristina, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579988
- Sponsor's protocol ID
- NEOTIR
- Acronym
- NEOTIR
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18787384Croce 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.
PubMed 36227457Olivieri 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.
PubMed 32865777Yao 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.
PubMed 21705721Tuzcu 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.
PubMed 39535106Ozdikici 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.
PubMed 39982374Mikolajczak 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.
PubMed 26023906Kurtoglu 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.
PubMed 15309449Vade 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.
PubMed 9315183Kurtoglu 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.
PubMed 18296580Perry 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.
PubMed 12390993Mikolajczak 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.
PubMed 32580143Leger 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.
PubMed 24446653Kreisner 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.
PubMed 12919160van 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.
PubMed 33272083
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07579988
- Acronym / sponsor ID
- NEOTIR / NEOTIR
- Keywords
- thyroid, thyroid volume, reference values thyroid ultrasound, newborn
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- IRCCS Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy term newborns | – | Diagnostic Test: Thyroid ultrasoundHealthy, born between 37 to 42 weeks of gestational age |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 400 healthy term newborns, born between 37 to 42 weeks of gestational age
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid ultrasoundThyroid 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. | Diagnostic test | Healthy term newborns |
Primary outcome
Thyroid volume
Time frame: 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.
6 secondary outcomes
Correlation between neonatal thyroid volume and neonatal anthropometric parameters
Time frame: First week of life
Differences in thyroid volume between healthy and affected infants
Time frame: First week of life
Correlation between neonatal thyroid volume and neonatal thyroid function
Time frame: first week of life
Correlation between neonatal thyroid volume and maternal iodine status
Time frame: first week of life
association between neonatal thyroid volume and ethnicity
Time frame: first week of life
Association between neonatal thyroid volume and maternal pregnancy-related disorders
Time frame: first week of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Results publication: PubMed 18787384Koksal 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.
- Results publication: PubMed 36227457Croce 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.
- Results publication: PubMed 32865777Olivieri 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.
- Results publication: PubMed 21705721Yao 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.
- Results publication: PubMed 39535106Tuzcu 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.
- Results publication: PubMed 39982374Ozdikici 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.
- Results publication: PubMed 26023906Mikolajczak 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.
- Results publication: PubMed 15309449Kurtoglu 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.
- Results publication: PubMed 9315183Vade 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.
- Results publication: PubMed 18296580Kurtoglu 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.
- Results publication: PubMed 12390993Perry 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.
- Results publication: PubMed 32580143Mikolajczak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Volume and Thyroid Ultrasound, run by IRCCS Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Cristina Vigone, MD (+39 0226432625, vigone.mariacristina@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid volume (time frame: First week of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07579988, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.