Ultrasound Measurement of Thyroid Volume in Term Newborns

NCT07579988 | Not Yet Recruiting

• 1 other identifier: NEOTIR
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Thyroid Volume; Thyroid Ultrasound; Congenital Hypothyroidism; Healthy Newborns

Keywords

thyroid; thyroid volume; reference values thyroid ultrasound; newborn

Outcome Measures

Primary Outcomes (1)

• 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.

  First week of life

Secondary Outcomes (6)

• Correlation between neonatal thyroid volume and neonatal anthropometric parameters

  First week of life

• Differences in thyroid volume between healthy and affected infants

  First week of life

• Correlation between neonatal thyroid volume and neonatal thyroid function

  first week of life

• Correlation between neonatal thyroid volume and maternal iodine status

  first week of life

• association between neonatal thyroid volume and ethnicity

  first week of life

Study Arms (1)

Healthy term newborns

Healthy, born between 37 to 42 weeks of gestational age

Diagnostic Test: Thyroid ultrasound

Interventions

Thyroid ultrasound DIAGNOSTIC_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.

Healthy term newborns

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

400 healthy term newborns, born between 37 to 42 weeks of gestational age

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (16)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 9315183 RESULT

• 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.

  PMID: 18296580 RESULT

• 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.

  PMID: 12390993 RESULT

• 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.

  PMID: 32580143 RESULT

• 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.

  PMID: 24446653 RESULT

• 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.

  PMID: 12919160 RESULT

• 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.

  PMID: 33272083 RESULT

• 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.

  PMID: 19690557 RESULT

MeSH Terms

Conditions

Congenital Hypothyroidism; Thyroid Diseases

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism

Central Study Contacts

Maria Cristina Vigone, MD

CONTACT

+39 0226432625; vigone.mariacristina@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor - Specialist in Pediatrics Expert in Pediatric Endocrinology Head of the Thyroid Pathology Outpatient Clinic

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-04

Locations

IT (1)