UnknownNot Applicable

Ultrasound and Functional Thyroid Evaluation

Poland200 participantsStarted 2019-12-19

Plain-language 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. 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

Who can participate

Age range

1 Week – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume

Timeframe: at 32 and 36 weeks of PCA

Trial details

NCT IDNCT04208503

SponsorPrincess Anna Mazowiecka Hospital, Warsaw, Poland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-30

Contact for this trial

Aleksandra Mikolajczak, MD PhD

+48 603 440 112 aamikolajczak@wp.pl

View on ClinicalTrials.gov More Thyroid trials

Plain-language summary

Who can participate

Age range

1 Week – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume

Timeframe: at 32 and 36 weeks of PCA