Ultrasound Measurement of Thyroid Volume in Term Newborns (NEOTIR)
Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Maria Cristina Vigone, MD
- Numero di telefono: +39 0226432625
- Email: vigone.mariacristina@hsr.it
Luoghi di studio
-
-
Italy
-
Milan, Italy, Italia, 20132
- IRCCS Ospedale San Raffaele
-
-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
Healthy term newborns
Healthy, born between 37 to 42 weeks of gestational age
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Thyroid volume
Lasso di tempo: 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.
|
First week of life
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Correlation between neonatal thyroid volume and neonatal anthropometric parameters
Lasso di tempo: First week of life
|
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.
|
First week of life
|
|
Differences in thyroid volume between healthy and affected infants
Lasso di tempo: 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.
|
First week of life
|
|
Correlation between neonatal thyroid volume and neonatal thyroid function
Lasso di tempo: 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.
|
first week of life
|
|
Correlation between neonatal thyroid volume and maternal iodine status
Lasso di tempo: first week of life
|
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.
|
first week of life
|
|
association between neonatal thyroid volume and ethnicity
Lasso di tempo: first week of life
|
Comparison of neonatal thyroid volume (mL, assessed by ultrasound) across different ethnic groups, expressed as mean differences or regression coefficients.
|
first week of life
|
|
Association between neonatal thyroid volume and maternal pregnancy-related disorders
Lasso di tempo: first week of life
|
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.
|
first week of life
|
Collaboratori e investigatori
Sponsor
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- NEOTIR
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .