一项解释性随机安慰剂对照试验，评估左旋甲状腺素补充剂对 <28 周龄早产儿的作用：TIPIT 试验结果。
An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trial.
机构信息
Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.
出版信息
Trials. 2013 Jul 11;14:211. doi: 10.1186/1745-6215-14-211.
BACKGROUND
Babies born before 28 weeks' gestation have lower plasma thyroid hormone concentrations than more mature infants. This may contribute to their risk of poor developmental outcome. Previous studies have suggested that thyroxine supplementation for extremely preterm neonates may be beneficial. The aim of this study was to investigate the effect of administration of supplemental thyroxine to very premature babies on brain size and somatic growth at 36 weeks' corrected gestational age (CGA).
METHODS
In this explanatory multicentre double blind randomised placebo controlled trial, 153 infants born below 28 weeks' gestation were randomised to levothyroxine (LT4) supplementation or placebo until 32 weeks' CGA. The primary outcome was brain size assessed by the width of the subarachnoid space measured by cranial ultrasound at 36 weeks' CGA. Lower leg length was measured by knemometry.
RESULTS
Babies in the LT4-supplemented and placebo groups had similar baseline characteristics. There were no significant differences between infants given LT4 (n=78) or placebo (n=75) for width of the subarachnoid space, head circumference at 36 weeks' CGA, body weight at 36 weeks' CGA or mortality. Infants who received LT4 had significantly shorter leg lengths at 36 weeks' CGA although adjusted analysis for baseline length did not find a statistical difference. There was a significant correlation between low FT4 and wider subarachnoid space. No unexpected serious adverse events were noted and incidence of adverse events did not differ between the two groups.
CONCLUSION
This is the only randomised controlled trial of thyroxine supplementation targeting extremely premature infants. Supplementing all babies below 28 weeks' gestation with LT4 had no apparent effect on brain size. These results do not support routine supplementation with LT4 for all babies born below 28 weeks' gestation.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN89493983EUDRACT number: 2005-003-09939.
背景
28 周胎龄前出生的婴儿的血浆甲状腺激素浓度低于更成熟的婴儿。这可能导致他们发育不良的风险增加。先前的研究表明，给极早产儿补充甲状腺素可能是有益的。本研究旨在探讨给非常早产儿补充甲状腺素对 36 周校正胎龄（CGA）时大脑大小和躯体生长的影响。
方法
在这项解释性多中心双盲随机安慰剂对照试验中，153 名胎龄低于 28 周的婴儿被随机分配至左甲状腺素（LT4）补充组或安慰剂组，直至 32 周 CGA。主要结局是通过 36 周 CGA 时的颅超声测量的蛛网膜下腔宽度评估的大脑大小。通过 knemometry 测量小腿长度。
结果
LT4 补充组和安慰剂组的婴儿具有相似的基线特征。给予 LT4（n=78）或安慰剂（n=75）的婴儿在蛛网膜下腔宽度、36 周 CGA 时的头围、36 周 CGA 时的体重或死亡率方面无显著差异。接受 LT4 的婴儿在 36 周 CGA 时的腿长明显较短，但对基线长度进行调整分析后并未发现统计学差异。FT4 低与蛛网膜下腔增宽有显著相关性。未发现意外的严重不良事件，两组的不良事件发生率无差异。
结论
这是唯一一项针对极早产儿的甲状腺素补充随机对照试验。给所有胎龄低于 28 周的婴儿补充 LT4 对大脑大小没有明显影响。这些结果不支持常规给所有胎龄低于 28 周的婴儿补充 LT4。
试验注册
当前对照试验 ISRCTN89493983EUDRACT 编号：2005-003-09939。
Zotero 插件