Great Ormond Street Institute of Child Health, University College London, London, UK
Great Ormond Street Institute of Child Health, University College London, London, UK.
BMJ Open. 2020 Jul 23;10(7):e035968. doi: 10.1136/bmjopen-2019-035968.
The effect of infant nutrition on long-term cognition is important for parents and policy makers. However, most clinical trials typically have short follow-up periods, when measures of cognition are poorly predictive of later function. The few trials with longer-term follow-up have high levels of attrition, which can lead to selection bias, and in turn to erroneous interpretation of long-term harms and benefits of infant nutrition. We address the need for unbiased, long-term follow-up, by linking measures of educational performance from administrative education records. Educational performance is a meaningful marker of cognitive function in children and it is strongly correlated with IQ. We aim to evaluate educational performance for children who, as infants, were part of a series of trials that randomised participants to either nutritionally modified infant formula or standard formula. Most trialists anticipated positive effects of these interventions on later cognitive function.
Using data from 1923 participants of seven randomised infant formula trials linked to the English National Pupil Database (NPD), this study will provide new insights into the effect of nutrient intake in infancy on school achievement. Our primary outcome will be the mean differences in z-scores between intervention and control groups for a compulsory Mathematics exam sat at age 16. Secondary outcomes will be z-scores for a compulsory English exam at age 16 and z-scores for compulsory Mathematics and English exams at age 11. We will also evaluate intervention effects on the likelihood of receiving special educational needs (SEN) support. All analyses will be performed separately by trial.
Research ethics approval, and approval from the Health Research Authority Confidentiality Advisory Group, has been obtained for this study. The results of this study will be disseminated to scientific, practitioner, and lay audiences, submitted for publication in peer-reviewed journals, and will contribute towards a PhD dissertation.
婴儿营养对长期认知的影响对父母和政策制定者来说很重要。然而，大多数临床试验通常随访时间较短，此时认知测量对以后的功能预测效果不佳。少数随访时间较长的试验存在较高的失访率，这可能导致选择偏倚，进而错误地解释婴儿营养的长期危害和益处。我们通过将教育记录中的教育表现测量结果联系起来，满足了对无偏、长期随访的需求。教育表现是儿童认知功能的一个有意义的标志，与智商高度相关。我们旨在评估那些作为婴儿参加了一系列随机分配参与者接受营养改良婴儿配方或标准配方的试验的儿童的教育表现。大多数试验者预期这些干预措施对以后的认知功能有积极影响。
利用来自 1923 名参与七项随机婴儿配方试验的参与者的数据，并与英国国家学生数据库（NPD）相关联，这项研究将为了解婴儿期营养摄入对学业成绩的影响提供新的见解。我们的主要结果将是干预组和对照组在 16 岁时参加的必修数学考试的 z 分数之间的平均差异。次要结果将是 16 岁时必修英语考试的 z 分数以及 11 岁时必修数学和英语考试的 z 分数。我们还将评估干预对获得特殊教育需求（SEN）支持的可能性的影响。所有分析都将按试验分别进行。
这项研究已获得研究伦理批准以及健康研究管理局保密性咨询小组的批准。这项研究的结果将传播给科学、实践和非专业受众，提交给同行评议期刊发表，并将有助于博士论文的撰写。
