Moffatt M E, Longstaffe S, Besant J, Dureski C
Department of Community Health Sciences, University of Manitoba, Winnipeg, Canada.
J Pediatr. 1994 Oct;125(4):527-34. doi: 10.1016/s0022-3476(94)70003-6.
To determine the efficacy of iron-fortified infant formula in preventing developmental delays and abnormal behavior.
Double-blind, randomized, controlled trial.
Urban hospital clinic.
A total of 283 healthy, bottle-fed infants from very low income families. Children with prematurity, low birth weight, and major anomalies and those who had received more than 2 weeks of evaporated-milk feedings were excluded. The groups were similar for sociodemographic background variables. Fifty-eight infants (20.5%) dropped out before any outcome data were gathered; 225, 204, 186, and 154 remained at 6-, 9-, 12-, and 15-month assessments, respectively.
Iron-fortified formula (12.8 mg iron per liter) versus regular formula (1.1 mg iron per liter).
Iron status was measured on venous blood by determination of hemoglobin, serum iron and iron-binding capacity, serum ferritin, and free erythrocyte protoporphyrin values. The Bayley Scales of Infant Development (mental and psychomotor indexes) and two factors of the Infant Behavior Record (test affect and task orientation) were the outcomes of interest.
All measures of iron status were significantly different between groups (p < 0.001). Psychomotor development patterns differed between groups (F3,520, 3.4; p = 0.02) with time. Mean values were similar at 6 months but differed at 9 and 12 months of age (p < 0.001), with a decline of 6.4 points in the regular-formula group. By 15 months of age the differences were no longer significant (p = 0.23). Mental development and behavior were not affected.
Iron-fortified formula significantly reduced iron deficiency in a high-risk group of infants and prevented a decline in psychomotor development quotients. This effect may be transient, and its long-term significance needs further study.
确定铁强化婴儿配方奶粉在预防发育迟缓及异常行为方面的疗效。
双盲、随机、对照试验。
城市医院诊所。
共283名来自低收入家庭的健康瓶喂婴儿。排除早产、低出生体重、有重大畸形以及接受过超过2周蒸发乳喂养的儿童。两组在社会人口学背景变量方面相似。58名婴儿（20.5%）在收集任何结局数据之前退出；分别有225名、204名、186名和154名婴儿在6个月、9个月、12个月和15个月评估时仍参与研究。
铁强化配方奶粉（每升含12.8毫克铁）与常规配方奶粉（每升含1.1毫克铁）。
通过测定血红蛋白、血清铁和铁结合能力、血清铁蛋白以及游离红细胞原卟啉值，对静脉血进行铁状态检测。感兴趣的结局指标为贝利婴儿发育量表（智力和精神运动指数）以及婴儿行为记录的两个因子（测试情感和任务导向）。
两组间所有铁状态指标均有显著差异（p < 0.001）。随着时间推移，两组间精神运动发育模式存在差异（F3,520 = 3.4；p = 0.02）。6个月时均值相似，但在9个月和12个月龄时存在差异（p < 0.001），常规配方奶粉组下降了6.4分。到15个月龄时，差异不再显著（p = 0.23）。智力发育和行为未受影响。
铁强化配方奶粉显著降低了高危组婴儿的缺铁情况，并预防了精神运动发育商数的下降。这种效果可能是短暂的，其长期意义需要进一步研究。
