ThyroidNCT04208503
Ultrasound and Functional Thyroid Evaluation
An observational study of Thyroid and Gland; Functional Disturbance, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 week to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Gland; Functional Disturbance
- What is being tested?
- thyroid ultrasound
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 19 Dec 2019to 31 Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.
Who may be able to join
- preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
- in born or admitted to the unit within one week from birth
- randomization within 7 days from birth
- parental consent
Who cannot join
- preterm delivery <23 weeks of gestation or > 32 weeks (estimated by ultrasound)
- major congenital abnormalities
- no parental consent
- medications used after birth: steroids, vasopressors (up to 12 hours after end of treatment)
- positive thyroid stimulating antibodies (TSAb) in the mother
- mothers with thyroid disease treated with antythyroid drugs
- mothers treated with amiodarone
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315
Joanna Seliga-Siwecka, MD PhD, +48225966155, seliga.joanna@gmail.com
Joanna Seliga-Siwecka
- Not yet recruiting
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw
About this study
Official title: Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation
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.
The 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
Read the detailed description
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.
The 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
- Conditions
- Thyroid, Gland; Functional Disturbance
- Being tested
- thyroid ultrasound
- Keywords
- thyroid volume, ultrasound, preterm infants, thyroid hormone
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid ultrasoundDiagnostic test
Also called Diagnostic test, blood test for TSH and FT4 concentration
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation
FT4 and TSH - blood concentration
Measured: 14-21 days of life, at 32 and 36 weeks of PCA
Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation
FT4 and TSH - blood concentration
Measured: at 14-21 day of life, at 32 and 36 weeks of PCA
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)
The thyroid volume
Measured: at 32 and 36 weeks of PCA
Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume
comparison of values of FT4, TSH and thyroid volume
Measured: at 32 and 36 weeks of PCA
Secondary outcomes (5)
Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants
comparison of results
Measured: at 14-21 day of life, at 32 and 36 weeks of PCA
Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants
comparison of results
Measured: 14-21 days of life, at 32 and 36 weeks of PCA
Analysis of TSH values over time (to determine the optimal time for TSH measurement)
Intervention time
Measured: at 14-21 day of life, at 32 and 36 weeks of PCA
Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants
comparison of results
Measured: at 32 and 36 weeks of PCA
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
correlation of results with the body mass and the head circumference
Measured: at 32 and 36 weeks of PCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start19 Dec 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Mikolajczak, MD PhD, Study chair, Princess Anna Mazowiecka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208503
- Sponsor's protocol ID
- 3/2019
- Status last verified
- Aug 2021
- First submitted
- 13 Dec 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.
Publications
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.
PubMed 29406004McGrath 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.
PubMed 30529133Radetti 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.
PubMed 12244277Vigone 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.
PubMed 24518164Khan 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.
PubMed 30061589Oh 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.
PubMed 25150803Kurtoglu 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.
PubMed 18296580Goldis 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.
PubMed 27241963Knobel 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.
PubMed 17710960Kaluarachchi 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.
PubMed 27906195
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT04208503
- Acronym / sponsor ID
- 3/2019
- Conditions
- Thyroid, Gland; Functional Disturbance
- Keywords
- thyroid volume, ultrasound, preterm infants, thyroid hormone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, PolandUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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
Detailed description
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.
The 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 1 week to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.
Key inclusion criteria (4 listed)
- preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
- in born or admitted to the unit within one week from birth
- randomization within 7 days from birth
- parental consent
Key exclusion criteria (7 listed)
- preterm delivery <23 weeks of gestation or > 32 weeks (estimated by ultrasound)
- major congenital abnormalities
- no parental consent
- medications used after birth: steroids, vasopressors (up to 12 hours after end of treatment)
- positive thyroid stimulating antibodies (TSAb) in the mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroid ultrasoundAlso: Diagnostic test, blood test for TSH and FT4 concentrationAfter 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 | Diagnostic test | – |
Primary outcome
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation
Time frame: 14-21 days of life, at 32 and 36 weeks of PCA
FT4 and TSH - blood concentration
Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation
Time frame: at 14-21 day of life, at 32 and 36 weeks of PCA
FT4 and TSH - blood concentration
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)
Time frame: at 32 and 36 weeks of PCA
The thyroid volume
Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume
Time frame: at 32 and 36 weeks of PCA
comparison of values of FT4, TSH and thyroid volume
5 secondary outcomes
Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants
Time frame: at 14-21 day of life, at 32 and 36 weeks of PCA
Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants
Time frame: 14-21 days of life, at 32 and 36 weeks of PCA
Analysis of TSH values over time (to determine the optimal time for TSH measurement)
Time frame: at 14-21 day of life, at 32 and 36 weeks of PCA
Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants
Time frame: at 32 and 36 weeks of PCA
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
Time frame: at 32 and 36 weeks of PCA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Background: PubMed 29406004Chaudhari 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.
- Background: PubMed 30529133McGrath 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.
- Background: PubMed 12244277Radetti 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.
- Background: PubMed 24518164Vigone 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.
- Background: PubMed 30061589Khan 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.
- Background: PubMed 25150803Oh 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.
- Background: PubMed 18296580Kurtoglu 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.
- Background: PubMed 27241963Goldis 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.
- Background: PubMed 17710960Knobel 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.
- Background: PubMed 27906195Kaluarachchi 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Mikolajczak, MD PhD study chair
Princess Anna Mazowiecka
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Gland; Functional Disturbance, run by Princess Anna Mazowiecka Hospital, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Mikolajczak, MD PhD (+48 603 440 112, aamikolajczak@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation (time frame: 14-21 days of life, at 32 and 36 weeks of PCA). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208503, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.