Thyroid size in healthy, full-term newborns
Official title: Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study
Run by IRCCS Ospedale San Raffaele · NCT07579988 · Data updated 2026-11-12
This study tests whether thyroid volume measured by ultrasound in healthy full-term newborns in Italy falls within expected ranges.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 7 Days |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | IRCCS Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milan, Lombardy) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07579988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy full-term newborns (37–42 weeks gestation) whose parents or guardians provide informed consent.
✕Probably not a fit
Newborns with congenital malformations or abnormal TSH screening results may not benefit from this normative dataset.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects thyroid ultrasound measurements from healthy full-term newborns (37–42 weeks gestation) to establish normative thyroid volume values. The goal is to link thyroid size with maternal and neonatal factors and to support newborn screening for congenital hypothyroidism. Ultrasound provides non-invasive, real-time data on gland size, position, and structure to help interpret future findings in clinical settings. Results will help contextualize thyroid measurements in babies who require further screening or investigation. The study emphasizes compliance with consent and exclusion of infants with congenital anomalies or abnormal screening TSH results.
Why it matters
Potential benefit: Establishing reference thyroid volume values could improve interpretation of neonatal thyroid assessments and support early detection of abnormalities.
How similar studies have gone: Previous research using ultrasound to establish pediatric thyroid norms has aided clinical interpretation, though country-specific normative data are often needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy Recruiting
Study contacts
- Study coordinator: Maria Cristina Vigone, MD
- Email: vigone.mariacristina@hsr.it
- Phone: +39 0226432625
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.