Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT04208503
Status:
UNKNOWN
Last Update Posted:
2021-08-16
First Post:
2019-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound and Functional Thyroid Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003955', 'term': 'Diagnostic Tests, Routine'}, {'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '1 ml blood for TSH and FT4 assessment'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-08', 'studyFirstSubmitDate': '2019-12-13', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation', 'timeFrame': '14-21 days of life, at 32 and 36 weeks of PCA', 'description': 'FT4 and TSH - blood concentration'}, {'measure': 'Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation', 'timeFrame': 'at 14-21 day of life, at 32 and 36 weeks of PCA', 'description': 'FT4 and TSH - blood concentration'}, {'measure': 'Determination of ultrasound thyroid volume in both groups of preterm infants (i.e., those born at 24-28 weeks of gestation and those born at 29-32 weeks of gestation)', 'timeFrame': 'at 32 and 36 weeks of PCA', 'description': 'The thyroid volume'}, {'measure': 'Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume', 'timeFrame': 'at 32 and 36 weeks of PCA', 'description': 'comparison of values of FT4, TSH and thyroid volume'}], 'secondaryOutcomes': [{'measure': 'Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants', 'timeFrame': 'at 14-21 day of life, at 32 and 36 weeks of PCA', 'description': 'comparison of results'}, {'measure': 'Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants', 'timeFrame': '14-21 days of life, at 32 and 36 weeks of PCA', 'description': 'comparison of results'}, {'measure': 'Analysis of TSH values over time (to determine the optimal time for TSH measurement)', 'timeFrame': 'at 14-21 day of life, at 32 and 36 weeks of PCA', 'description': 'Intervention time'}, {'measure': 'Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants', 'timeFrame': 'at 32 and 36 weeks of PCA', 'description': 'comparison of results'}, {'measure': 'Evaluation of the correlation between thyroid volume and circulating thyroid hormone concentrations with the head circumference and body mass at 32 and 36 weeks of PCA', 'timeFrame': 'at 32 and 36 weeks of PCA', 'description': 'correlation of results with the body mass and the head circumference'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid volume', 'ultrasound', 'preterm infants', 'thyroid hormone'], 'conditions': ['Thyroid', 'Gland; Functional Disturbance']}, 'referencesModule': {'references': [{'pmid': '29406004', 'type': 'BACKGROUND', 'citation': 'Chaudhari M, Slaughter JL. Thyroid Function in the Neonatal Intensive Care Unit. Clin Perinatol. 2018 Mar;45(1):19-30. doi: 10.1016/j.clp.2017.10.005. Epub 2017 Dec 13.'}, {'pmid': '30529133', 'type': 'BACKGROUND', 'citation': 'McGrath N, Hawkes CP, Mayne P, Murphy NP. Optimal Timing of Repeat Newborn Screening for Congenital Hypothyroidism in Preterm Infants to Detect Delayed Thyroid-Stimulating Hormone Elevation. J Pediatr. 2019 Feb;205:77-82. doi: 10.1016/j.jpeds.2018.09.044. Epub 2018 Oct 24.'}, {'pmid': '12244277', 'type': 'BACKGROUND', 'citation': 'Radetti G, Zavallone A, Gentili L, Beck-Peccoz P, Bona G. Foetal and neonatal thyroid disorders. Minerva Pediatr. 2002 Oct;54(5):383-400. English, Italian.'}, {'pmid': '24518164', 'type': 'BACKGROUND', 'citation': 'Vigone MC, Caiulo S, Di Frenna M, Ghirardello S, Corbetta C, Mosca F, Weber G. Evolution of thyroid function in preterm infants detected by screening for congenital hypothyroidism. J Pediatr. 2014 Jun;164(6):1296-302. doi: 10.1016/j.jpeds.2013.12.048. Epub 2014 Feb 8.'}, {'pmid': '30061589', 'type': 'BACKGROUND', 'citation': 'Khan SS, Hong-McAtee I, Kriss VM, Stevens S, Crawford T, Hanna M, Bada H, Desai N. Thyroid gland volumes in premature infants using serial ultrasounds. J Perinatol. 2018 Oct;38(10):1353-1358. doi: 10.1038/s41372-018-0149-0. Epub 2018 Jul 30.'}, {'pmid': '25150803', 'type': 'BACKGROUND', 'citation': 'Oh KW, Koo MS, Park HW, Chung ML, Kim MH, Lim G. Establishing a reference range for triiodothyronine levels in preterm infants. Early Hum Dev. 2014 Oct;90(10):621-4. doi: 10.1016/j.earlhumdev.2014.07.012. Epub 2014 Aug 24.'}, {'pmid': '18296580', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27241963', 'type': 'BACKGROUND', 'citation': 'Goldis M, Waldman L, Marginean O, Rosenberg HK, Rapaport R. Thyroid Imaging in Infants. Endocrinol Metab Clin North Am. 2016 Jun;45(2):255-66. doi: 10.1016/j.ecl.2016.02.005.'}, {'pmid': '17710960', 'type': 'BACKGROUND', 'citation': 'Knobel RB. Thyroid hormone levels in term and preterm neonates. Neonatal Netw. 2007 Jul-Aug;26(4):253-9. doi: 10.1891/0730-0832.26.4.253.'}, {'pmid': '27906195', 'type': 'BACKGROUND', 'citation': 'Kaluarachchi DC, Colaizy TT, Pesce LM, Tansey M, Klein JM. Congenital hypothyroidism with delayed thyroid-stimulating hormone elevation in premature infants born at less than 30 weeks gestation. J Perinatol. 2017 Mar;37(3):277-282. doi: 10.1038/jp.2016.213. Epub 2016 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'Thyroid disorders are most commonly concomitant with prematurity and still remains a controversial topic. The incidence of a temporary form of hypothyroidism among preterm neonates is higher than in the general population. Transient prematurity hypothyroxinemia is defined as a temporary reduction in FT4 values without increase in TSH values. Currently, there is no consensus about normal thyrotropine (TSH) and free thyroxine (FT4) values in preterm infants.\n\nThe aim of this study is to determine the volume of the thyroid gland in preterm infants born between 24 and 32 weeks of gestation inborn or admitted to the unit within 14 days from birth and compare it with the results of TSH and FT4 blood concentration. Besides, the objective of the study is to determine values of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results', 'detailedDescription': 'Thyroid disorders are most commonly concomitant with prematurity and still remains a controversial topic. Preterm infants are susceptible to thyroid disorders due to many reasons including immaturity of hypothalamopituitary-thyroid axis, non-thyroidal illness, impaired synthesis and metabolism of thyroid hormones, medication administration like dopamine, steroids, caffeine.The incidence of a temporary form of hypothyroidism among preterm neonates is higher than in the general population. Transient prematurity hypothyroxinemia is defined as a temporary reduction in FT4 values without increase in TSH values. It is a diagnostic challenge in order to differentiate it from thyroid disfunction in the critically ill patient. Currently, there is no consensus about normal thyrotropine (TSH) and free thyroxine (FT4) values in preterm infants. Given the delayed appearance of TSH value increase in preterm newborns additional thyroid evaluation methods are sought. We believe the thyroid ultrasound might prove helpful.\n\nThe aim of this study is to determine the volume of the thyroid gland in preterm infants born between 24 and 32 weeks of gestation inborn or admitted to the unit within 14 days from birth and compare it with the results of TSH and FT4 blood concentration. We will performed the thyroid ultrasound to estimate the thyroid volume to aid in the comparative evaluation of infants with suspected thyroid disease. The value of sonography thyroid volume will give specialists possibility to identify a gland as normal, small or enlarged. Besides, the objective of the study is to determine value of thyroid hormones in premature infants born before 33 wk gestation to help neonatologist to interpreter the thyroid hormone results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '1 Week', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)\n* in born or admitted to the unit within one week from birth\n* randomization within 7 days from birth\n* parental consent\n\nExclusion Criteria:\n\n* preterm delivery \\<23 weeks of gestation or \\> 32 weeks (estimated by ultrasound)\n* major congenital abnormalities\n* no parental consent\n* medications used after birth: steroids, vasopressors (up to 12 hours after end of treatment)\n* positive thyroid stimulating antibodies (TSAb) in the mother\n* mothers with thyroid disease treated with antythyroid drugs\n* mothers treated with amiodarone'}, 'identificationModule': {'nctId': 'NCT04208503', 'briefTitle': 'Ultrasound and Functional Thyroid Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland'}, 'officialTitle': 'Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation', 'orgStudyIdInfo': {'id': '3/2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'thyroid ultrasound', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diagnostic test', 'blood test for TSH and FT4 concentration'], 'description': 'After meeting enrolment criteria the thyroid ultrasound will be performed at 32 and 36 weeks of gestation, blood test for TSH and FT4 will be obtained at 14-21 day of life, at 32 and 36 weeks of gestation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-315', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Joanna Seliga-Siwecka, MD PhD', 'role': 'CONTACT', 'email': 'seliga.joanna@gmail.com', 'phone': '+48225966155'}, {'name': 'Joanna Seliga-Siwecka', 'role': 'CONTACT'}], 'facility': 'Department of Neonatology and Neonatal Intensive Care Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Warsaw', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Department of Neonatology and Neonatal Intensive Care Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Aleksandra Mikolajczak, MD PhD', 'role': 'CONTACT', 'email': 'aamikolajczak@wp.pl', 'phone': '+48 603 440 112'}, {'name': 'Renata Bokiniec, Prof MD P', 'role': 'CONTACT', 'email': 'r.bokiniec@wp.pl', 'phone': '+48 22 59 66 155'}], 'overallOfficials': [{'name': 'Aleksandra Mikolajczak, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Anna Mazowiecka'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'January 2021-December 2021', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.', 'accessCriteria': 'Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}