- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579988
Ultrasound Measurement of Thyroid Volume in Term Newborns (NEOTIR)
2026년 5월 5일 업데이트: Vigone Maria Cristina, IRCCS Ospedale San Raffaele
Ultrasound Measurement of Thyroid Volume in Term Newborns : a Single-centre Cross Sectional Observational Study
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.
연구 개요
상태
아직 모집하지 않음
개입 / 치료
상세 설명
The thyroid is a fundamental endocrine gland that regulates metabolism throughout the life cycle.
Thyroid's function is particularly crucial in fetuses, newborns, and children, as thyroid hormones play a key role in the development of the central nervous system.
A deficiency of thyroid hormones in childbearing age women due to untreated hypothyroidism, autoimmune disorders or iodine deficiency poses a threat to both fertility and pregnancy progression and can negatively impact fetal and neonatal neurological outcomes later in life.
Since the introduction of neonatal TSH- screening method the prognosis of newborn with congenital hypothyroidism has significantly improved due to early start of levothyroxine treatment.
The findings of reduced or increased thyroid size in newborn with TSH elevation can support the need for further investigation such as genetic analysis.
For this reason, having normative data of thyroid volume is fundamental in newborn population.
According to the current guidelines for congenital hypothyroidism, the primary imaging techniques for evaluating neonatal thyroid include ultrasound and radionuclide scintigraphy.
Ultrasound is the preferred modality due to its non-invasive nature and ability to provide detailed information about the gland's structure, size, position, vascularization, and echogenicity.
Thyroid volume is tightly regulated during fetal development, and variations in size may indicate pathological maternal and neonatal dysfunctions.
Therefore, thyroid volume measurement is a crucial indicator for monitoring the gland's development and function in newborns and is strongly associated to environmental factor such as iodine status and maternal factors.
International studies conducted in countries with different iodine status and national salt iodization programs (Poland, Germany, Belgium, Turkey, United Kidgdom, United States China, Brazil) have shown significant variations in average thyroid volume values in euthyroid term newborn ranging from 0.47 in the Unites States to and 1.62 ml in the United Kingdom.
These findings highlight the importance of geography and iodine supplementation in determining neonatal thyroid volume.
Ultrasound of the thyroid gland was generally recorded during the first three weeks of life.
However, no reference data are currently available for Italian newborns.
Italy is considered an iodine sufficient area but there is an increased risk of deficiency during pregnancy.
Establishing specific reference values of newborn thyroid volume for the Italian population is therefore necessary.
In addition to the geographical region of origin, several maternal factors may influence neonatal thyroid volume, including levothyroxine intake in cases of hypothyroidism, nutritional iodine supply/intake, use of medications/disinfectants containing iodine, gestational diabetes and smoking during pregnancy.
One study found a negative correlation between high maternal levothyroxine doses and neonatal thyroid volume.
Although this correlation is weak, multivariate logistic models confirmed the impact of maternal therapy on neonatal thyroid volume.
Excess maternal thyroid hormones can suppress fetal TSH secretion, limiting follicular cell proliferation, leading to a reduced neonatal thyroid volume.
Studies about the association between gestational diabetes and thyroid neonatal volume reported difference results.
Smoking during pregnancy has also been associated with variations in neonatal thyroid volume.
Studies on adults have shown a 25% increase in thyroid volume in smokers compared to non-smokers.
The high prevalence of smoking among young women in certain regions could explain an increased neonatal thyroid volume.
This study is essential for establishing national reference values for thyroid volume in healthy term and preterm Italian newborns, addressing a gap in the available data.
Understanding geographical differences, maternal influences, and the newborn characteristics of preterm newborns will improve the monitoring and management of neonatal thyroid conditions, with potential implications for public and neonatal health.
연구 유형
관찰
등록 (추정된)
400
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Maria Cristina Vigone, MD
- 전화번호: +39 0226432625
- 이메일: vigone.mariacristina@hsr.it
연구 장소
-
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Italy
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Milan, Italy, 이탈리아, 20132
- IRCCS Ospedale San Raffaele
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
400 healthy term newborns, born between 37 to 42 weeks of gestational age
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Healthy term newborns
Healthy, born between 37 to 42 weeks of gestational age
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Thyroid volume
기간: 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.
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First week of life
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Correlation between neonatal thyroid volume and neonatal anthropometric parameters
기간: First week of life
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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.
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First week of life
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Differences in thyroid volume between healthy and affected infants
기간: First week of life
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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.
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First week of life
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Correlation between neonatal thyroid volume and neonatal thyroid function
기간: first week of life
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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.
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first week of life
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Correlation between neonatal thyroid volume and maternal iodine status
기간: first week of life
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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.
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first week of life
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association between neonatal thyroid volume and ethnicity
기간: first week of life
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Comparison of neonatal thyroid volume (mL, assessed by ultrasound) across different ethnic groups, expressed as mean differences or regression coefficients.
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first week of life
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Association between neonatal thyroid volume and maternal pregnancy-related disorders
기간: 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.
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first week of life
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2027년 5월 1일
연구 완료 (추정된)
2027년 5월 1일
연구 등록 날짜
최초 제출
2026년 4월 28일
QC 기준을 충족하는 최초 제출
2026년 5월 5일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NEOTIR
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .