Ultrasound and Functional Thyroid Evaluation in Preterm Infants Born Between 24 and 32 Weeks of Gestation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Determination of FT4 and TSH values in preterm infants born at 29-32 weeks of gestation
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: at 32 and 36 weeks of PCA
comparison of values of FT4, TSH and thyroid volume
次要结局
- 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)
- 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 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 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)
- 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)