Departments of Pediatrics and Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada.
Departments of Epidemiology, Biostatistics and Occupational Health, McGill University Faculty of Medicine, Montreal, Canada.
Am J Clin Nutr. 2018 Apr 1;107(4):635-639. doi: 10.1093/ajcn/nqy008.
Previous observational studies have consistently shown slower weight and length gains in infants with prolonged breastfeeding than in those who were formula-fed from birth or breastfed for a shorter duration. These studies inferred that prolonged breastfeeding causes slower growth in infancy.
We compared infant growth associated with ≥12 mo of breastfeeding with a shorter duration of breastfeeding on the basis of 3 different analytic approaches to the same data from a randomized trial: intention-to-treat (ITT; "as randomized"), observational ("as fed"), and instrumental variable (IV; by using randomization as an "instrument" to achieve ≥12 mo of breastfeeding).
This was a cluster-randomized trial of a breastfeeding-promotion intervention. Anthropometric measurements were obtained at birth and at 1, 2, 3, 6, 9, and 12 mo.
The 3 analytic approaches yielded different results. The ITT approach showed more rapid growth in the first 2 mo among infants randomly assigned to the breastfeeding-promotion intervention than among control infants, with a decreasing difference over the ensuing months and nearly identical weight, length, and body mass index by 12 mo. The observational analysis showed a different trend: higher weight and length in infants who were breastfed ≥12 mo than in those who were breastfed <12 mo during the first 3 mo and no difference by 6 mo, while infants who were breastfed <12 mo showed increasingly higher weight and length from 6 to 12 mo. The IV analysis showed a temporal pattern that was similar to that seen in the ITT analysis, but with larger (and less precise) differences between infants breastfed for ≥12 compared with <12 mo.
We observed major differences in experimental (ITT and IV) compared with observational approaches to analyzing data obtained from the same children. These approaches lead to opposite causal inferences about the relation between infant feeding and growth and underline the importance of ensuring that the postulated cause (feeding) temporally precedes its hypothesized effect (growth). This trial is registered at http://www.isrctn.org/ as ISRCTN37687716.
先前的观察性研究一致表明,与从出生起就配方喂养或母乳喂养时间较短的婴儿相比,长时间母乳喂养的婴儿体重和身长增长较慢。这些研究推断,延长母乳喂养会导致婴儿期生长缓慢。
我们根据同一项随机试验的三种不同分析方法,即意向治疗(ITT;“按随机分组”)、观察(“按喂养情况”)和工具变量(IV;通过将随机分组作为实现≥12 个月母乳喂养的“工具”),比较与较短母乳喂养时间相比,≥12 个月母乳喂养与婴儿生长的关系。
这是一项促进母乳喂养的干预措施的集群随机试验。在出生时和 1、2、3、6、9 和 12 个月时进行人体测量。
三种分析方法得出了不同的结果。意向治疗方法显示,随机分配到母乳喂养促进干预组的婴儿在前 2 个月的生长速度比对照组婴儿更快,随后几个月的差异逐渐减小,到 12 个月时体重、身长和体重指数几乎相同。观察性分析显示出不同的趋势:在最初的 3 个月中,母乳喂养≥12 个月的婴儿体重和身长较高,而母乳喂养<12 个月的婴儿在 6 个月时没有差异,而母乳喂养<12 个月的婴儿从 6 个月到 12 个月体重和身长逐渐增加。工具变量分析显示出与意向治疗分析相似的时间模式,但母乳喂养≥12 个月与<12 个月的婴儿之间的差异更大(且精度较低)。
我们观察到,与分析同一批儿童数据的观察性方法相比,实验(ITT 和 IV)方法存在显著差异。这些方法导致关于婴儿喂养与生长之间关系的因果推断完全相反,并强调了确保所假定的原因(喂养)在其假设的效果(生长)之前发生的重要性。这项试验在 http://www.isrctn.org/ 注册,注册号为 ISRCTN37687716。