足月等效龄时接受高剂量二十二碳六烯酸喂养的早产儿7岁时的神经发育结局：一项随机对照试验的随访
Neurodevelopmental outcomes at 7 years' corrected age in preterm infants who were fed high-dose docosahexaenoic acid to term equivalent: a follow-up of a randomised controlled trial.
作者信息
Collins Carmel T, Gibson Robert A, Anderson Peter J, McPhee Andrew J, Sullivan Thomas R, Gould Jacqueline F, Ryan Philip, Doyle Lex W, Davis Peter G, McMichael Judy E, French Noel P, Colditz Paul B, Simmer Karen, Morris Scott A, Makrides Maria
机构信息
Women's and Children's Health Research Institute, North Adelaide, South Australia, Australia Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia School of Paediatrics and Reproductive Health, The University of Adelaide, Adelaide, South Australia, Australia FOODplus Research Centre, The University of Adelaide, Adelaide, South Australia, Australia.
Women's and Children's Health Research Institute, North Adelaide, South Australia, Australia Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia FOODplus Research Centre, The University of Adelaide, Adelaide, South Australia, Australia.
出版信息
BMJ Open. 2015 Mar 18;5(3):e007314. doi: 10.1136/bmjopen-2014-007314.
OBJECTIVE
To determine if improvements in cognitive outcome detected at 18 months' corrected age (CA) in infants born <33 weeks' gestation receiving a high-docosahexaenoic acid (DHA) compared with standard-DHA diet were sustained in early childhood.
DESIGN
Follow-up of a multicentre randomised controlled trial. Randomisation was stratified for sex, birth weight (<1250 vs ≥1250 g) and hospital.
SETTING
Five Australian tertiary hospitals from 2008 to 2013.
PARTICIPANTS
626 of the 657 participants randomised between 2001 and 2005 were eligible to participate.
INTERVENTIONS
High-DHA (≈1% total fatty acids) enteral feeds compared with standard-DHA (≈0.3% total fatty acids) from age 2-4 days until term CA.
PRIMARY OUTCOME
Full Scale IQ of the Wechsler Abbreviated Scale of Intelligence (WASI) at 7 years CA. Prespecified subgroup analyses based on the randomisation strata (sex, birth weight) were conducted.
RESULTS
604 (92% of the 657 originally randomised) consented to participate (291 high-DHA, 313 standard-DHA). To address missing data in the 604 consenting participants (22 for primary outcome), multiple imputation was performed. The Full Scale IQ was not significantly different between groups (high-DHA 98.3, SD 14.0, standard-DHA 98.5, SD 14.9; mean difference adjusted for sex, birthweight strata and hospital -0.3, 95% CI -2.9 to 2.2; p=0.79). There were no significant differences in any secondary outcomes. In prespecified subgroup analyses, there was a significant sex by treatment interaction on measures of parent-reported executive function and behaviour. Scores were within the normal range but girls receiving the high-DHA diet scored significantly higher (poorer outcome) compared with girls receiving the standard-DHA diet.
CONCLUSIONS
Supplementing the diets of preterm infants with a DHA dose of approximately 1% total fatty acids from days 2-4 until term CA showed no evidence of benefit at 7 years' CA.
TRIAL REGISTRATION NUMBER
Australian New Zealand Clinical Trials Registry: ACTRN12606000327583.
目的
确定与接受标准二十二碳六烯酸（DHA）饮食的妊娠不足33周出生的婴儿相比，接受高DHA饮食的婴儿在18个月矫正年龄（CA）时检测到的认知结果改善在幼儿期是否持续存在。
设计
一项多中心随机对照试验的随访。随机分组按性别、出生体重（<1250 vs≥1250 g）和医院进行分层。
地点
2008年至2013年期间的五家澳大利亚三级医院。
参与者
2001年至2005年期间随机分组的657名参与者中有626名符合参与条件。
干预措施
从2至4日龄至足月CA，与标准DHA（约占总脂肪酸的0.3%）相比，高DHA（约占总脂肪酸的1%）肠内喂养。
主要结局
7岁CA时韦氏儿童智力量表简式版（WASI）的全量表智商。基于随机分组分层（性别、出生体重）进行了预先指定的亚组分析。
结果
604名（占最初随机分组的657名的92%）同意参与（291名高DHA组，313名标准DHA组）。为处理604名同意参与的参与者中的缺失数据（主要结局有22例缺失），进行了多重填补。两组之间的全量表智商无显著差异（高DHA组98.3，标准差14.0；标准DHA组98.5，标准差14.9；经性别、出生体重分层和医院校正后的平均差异为-0.3，95%可信区间为-2.9至2.2；p=0.79）。任何次要结局均无显著差异。在预先指定的亚组分析中，在家长报告的执行功能和行为测量方面，治疗与性别之间存在显著交互作用。分数在正常范围内，但接受高DHA饮食的女孩与接受标准DHA饮食的女孩相比得分显著更高（结局更差）。
结论
从2至4日龄至足月CA，用约占总脂肪酸1%的DHA剂量补充早产儿饮食，在7岁CA时未显示出有益证据。
试验注册号
澳大利亚新西兰临床试验注册中心：ACTRN12606000327583。
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