Ultrasound Measurement of Thyroid Volume in Term Newborns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-7
SponsorIRCCS Ospedale San Raffaele
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 population
400 healthy term newborns, born between 37 to 42 weeks of gestational age
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Thyroid ultrasound
Diagnostic testThyroid 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.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: Healthy term newborns1 intervention
Trial outcomes
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.
Time frame
First week of lifeSecondary outcomes
1
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.
Time frame
First week of life2
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.
Time frame
First week of life3
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.
Time frame
first week of life4
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.
Time frame
first week of lifeSponsors and contacts
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Source ClinicalTrials.gov
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