Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 3
- 主要终点
- Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.
研究概览
简要总结
Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.
In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 < 12 pmol/L and a level of TSH < 15 mUI/L before 15 days of life or < 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born before or at 3032 weeks of gestation
- •For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.
排除标准
- •Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
- •Associated polymalformative sindrome
研究组 & 干预措施
THOP treated
Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulatingon thyro-stimulating hormone < 15 mUI/L if the sample was realiszed before or on the fifteenth day of life OR < 58 mUI/L if the sample was realiszed after the fifteenth day of life, and L-thyroxine treatment is recorded in the medical record (at any dose and with any duration)
干预措施: L-thyroxine at a dose of 7.5 µg/kg/d for THOP (Drug)
THOP un-treated
Level of circulating T4 < 12 pmol/L at any time of life associated, on the same date, with a level of circulation thyro-stimulating hormone < 15 mUI/L if sample was realiszed before or on the fifteenth day of life OR < 5 mUI/L if sample was realiszed after the fifteenth day of life, and no L-thyroxine treatment recorded in the medical record.
干预措施: THOP without treatment (Other)
No-THOP
all level of circulating T4 > 12 pmol/L at any time in life
干预措施: NoTHOP (Other)
结局指标
主要结局
Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.
时间窗: Evaluation at two years of corrected age.
Neuro-development is evaluated routinely by paediatricians during consultation, and this evaluation is reported in medical files.
次要结局
未报告次要终点