Ultrasound and Functional Thyroid Evaluation
- Conditions
- Gland; Functional DisturbanceThyroid
- Registration Number
- NCT04208503
- Lead Sponsor
- Princess Anna Mazowiecka Hospital, Warsaw, Poland
- Brief 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
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation 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) at 32 and 36 weeks of PCA The thyroid volume
Determination of FT4 and TSH values in preterm infants born at 24-28 weeks of gestation 14-21 days of life, at 32 and 36 weeks of PCA FT4 and TSH - blood concentration
Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume at 32 and 36 weeks of PCA comparison of values of FT4, TSH and thyroid volume
- Secondary Outcome Measures
Name Time Method Analysis of TSH values over time (to determine the optimal time for TSH measurement) at 14-21 day of life, at 32 and 36 weeks of PCA Intervention time
Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants at 14-21 day of life, at 32 and 36 weeks of PCA comparison of results
Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants 14-21 days of life, at 32 and 36 weeks of PCA comparison of results
Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants at 32 and 36 weeks of PCA comparison of results
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 at 32 and 36 weeks of PCA correlation of results with the body mass and the head circumference
Trial Locations
- Locations (1)
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
🇵🇱Warsaw, Poland