Gland; Functional Disturbance, Thyroid
Conditions
Keywords
thyroid volume, ultrasound, preterm infants, thyroid hormone
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
Interventions
DIAGNOSTIC_TESTthyroid ultrasound
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
Sponsors
Princess Anna Mazowiecka Hospital, Warsaw, Poland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 12 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Poland
Contacts
Primary ContactAleksandra Mikolajczak, MD PhD
Backup ContactRenata Bokiniec, Prof MD P
Outcome results
None listed