An observational study in Thyroid and Gland; Functional Disturbance, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Status unknown at 2 sites in Poland. Open to participants aged 1 Week to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-16.
Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Observational
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
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
976 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's planned enrollment of 200 is above the median of 155 across 387 observational studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: Diagnostic test, blood test for TSH and FT4 concentration
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation
FT4 and TSH - blood concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 32 and 36 weeks of PCA
Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants
comparison of results
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
comparison of results
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)
Intervention time
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
comparison of results
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
correlation of results with the body mass and the head circumference
Time frame: at 32 and 36 weeks of PCA
Plan to share: Yes — All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: January 2021-December 2021
Access criteria: Documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
Started Dec 2019 (actual). Primary completion is estimated for Dec 2021, 24 months after the start.
Of 138 non-industry observational studies under Thyroid Diseases, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 131. This study's planned 24 months is below that.
Counting every sponsor, half of 147 studies reached it within 30 months; a quarter within 16 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Princess Anna Mazowiecka Hospital, Warsaw, Poland