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Ultrasound Measurement of Thyroid Volume in Term Newborns

NCT07579988 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IRCCS Ospedale San Raffaele

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2027-05-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579988 on ClinicalTrials.gov