Clinical trial NCT04208503: Ultrasound and Functional Thyroid Evaluation
Official title: Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid
Gland; Functional Disturbance
Keywords: thyroid volume
ultrasound
preterm infants
thyroid hormone
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to recruit all consecutive preterm infants born ≤ 32 weeks of gestation.

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: Evaluation of correlations between circulating thyroid hormone concentrations and thyroid volume
timeFrame: at 32 and 36 weeks of PCA
Secondary outcomes:
measure: Comparison of changes in FT4 evaluated at 32 and 36 weeks of PCA in each group of preterm infants
timeFrame: at 14-21 day of life, at 32 and 36 weeks of PCA
measure: Comparison of changes in TSH evaluated at 32 and 36 weeks of PCA in each group of preterm infants
timeFrame: 14-21 days of life, at 32 and 36 weeks of PCA
measure: Analysis of TSH values over time (to determine the optimal time for TSH measurement)
timeFrame: at 14-21 day of life, at 32 and 36 weeks of PCA
measure: Evaluation of changes in ultrasound thyroid volume examined at 32 and 36 weeks of PCA in each group of preterm infants
timeFrame: at 32 and 36 weeks of PCA
measure: 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
timeFrame: at 32 and 36 weeks of PCA
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Study officials:
affiliation: Princess Anna Mazowiecka
name: Aleksandra Mikolajczak, MD PhD
role: STUDY_CHAIR
References:
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citation: Kaluarachchi 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.