A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,275
- 试验地点
- 19
- 主要终点
- Appreciable neurodevelopmental impairment at 2 years corrected age. As measured by the three main domains of the Bayley III score: i.e. cognitive score, language composite score and motor composite score.
研究概览
简要总结
The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.
详细描述
Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal brain development in utero and for the first 2-3 years of life. The recommended iodine intake in parenteral nutrition regimens is 1 μg/kg/day and commercially available parenteral solutions for infants reflect these recommendations. In the absence of other iodine sources, infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants are fed parenterally for prolonged periods with solutions which have been shown to be iodine-deficient, the I2S2 Trial was designed as a UK multicentre randomised controlled trial to establish whether iodine supplementation of preterm infants benefits neurodevelopment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 42 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants born under 31 weeks gestation
排除标准
- •Mother exposed to excess iodine during pregnancy or delivery
研究组 & 干预措施
Iodine
This is the hypothetical active arm
干预措施: sodium iodide (Drug)
Placebo
this is the hypothetical placebo
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
Appreciable neurodevelopmental impairment at 2 years corrected age. As measured by the three main domains of the Bayley III score: i.e. cognitive score, language composite score and motor composite score.
时间窗: at 2 years corrected age
P ≤0.05 will be the level used to indicate statistical significance.Deaths and those infants with severe neurodevelopment disability will be scored 55 in the cognitive domain, 46 in the motor domain and 47 in the language domain. The primary outcome will be ordered as cognitive score, motor composite score and language composite score in all results presented.
次要结局
- Hearing and vision impairment(2 years corrected age)
- BAPM level of care(2 years corrected age)
- Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.(2 years corrected age)
- Neurodevelopment impairment as a composite of death or a Bayley III score of <85 in any of the score's three main subsets domains: cognitive, language and motor composites.(2 years corrected age)
- Type and severity of illness: necrotising enterocolitis(2 years corrected age)
- Type and severity of illness:persistent ductus arteriosus(2 years corrected age)
- Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age)(2 years corrected age)
- Acquired infection(2 years corrected age)
- Nutritional status(2 years corrected age)
- Neurodevelopmental impairment assessed as a difference between the iodine supplemented and placebo groups in each of the four subset scores of the Bayley III i.e. receptive communication, expressive communication, fine motor or gross motor.(2 years corrected age)
- Cranial ultrasound changes(2 years corrected age)
- Type and severity of illness: respiratory distress(2 years corrected age)
- Postnatal drug use(2 years corrected age)
- Highest recorded bilirubin levels(2 years corrected age)
- Death - immediate and underlying causes.(2 years corrected age)