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NOT YET RECRUITING
NCT07579988

Ultrasound Measurement of Thyroid Volume in Term Newborns

Sponsor: IRCCS Ospedale San Raffaele

View on ClinicalTrials.gov

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.

Official title: Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study

Key Details

Gender

All

Age Range

1 Day - 7 Days

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2026-05-01

Completion Date

2027-05-01

Last Updated

2026-05-12

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

IRCCS Ospedale San Raffaele

Milan, Italy, Italy