Gould Jacqueline F, Colombo John, Collins Carmel T, Makrides Maria, Hewawasam Erandi, Smithers Lisa G
Department of Healthy Mothers, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
School of Psychology, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, South Australia, Australia.
BMJ Open. 2018 May 26;8(5):e020043. doi: 10.1136/bmjopen-2017-020043.
Docosahexaenoic acid (DHA) accumulates in the frontal lobes (responsible for higher-order cognitive skills) of the fetal brain during the last trimester of pregnancy. Infants born preterm miss some of this in utero provision of DHA, and have an increased risk of suboptimal neurodevelopment. It is thought that supplementing infants born preterm with DHA may improve developmental outcomes. The aim of this follow-up is to determine whether DHA supplementation in infants born preterm can improve areas of the brain associated with frontal lobe function, namely attention and distractibility.
We will assess a subset of children from the N-3 (omega-3) Fatty Acids for Improvement in Respiratory Outcomes (N3RO) multicentre double-blind randomised controlled trial of DHA supplementation. Infants born <29 weeks' completed gestation were randomised to receive an enteral emulsion containing 60 mg/kg/day of DHA or a control emulsion from within the first 3 days of enteral feeding until 36 weeks' postmenstrual age.Children will undergo multiple measures of attention at 18 months' corrected age. The primary outcome is the average time to be distracted when attention is focused on a toy. Secondary outcomes are other aspects of attention, and (where possible) an assessment of cognition, language and motor development with the Bayley Scales of Infant and Toddler Development, Third Edition.A minimum of 72 children will be assessed to ensure 85% power to detect an effect on the primary outcome. Families, and research personnel are blinded to group assignment. All analyses will be conducted according to the intention-to-treat principal.
All procedures were approved by the relevant institutional ethics committees prior to commencement of the study. Results will be disseminated in peer-reviewed journal publications and academic presentations.
ACTRN12612000503820; Pre-results.
在妊娠晚期,二十二碳六烯酸(DHA)会在胎儿大脑的额叶(负责高阶认知技能)中蓄积。早产婴儿在子宫内无法获得部分DHA,其神经发育欠佳的风险会增加。人们认为,给早产婴儿补充DHA可能会改善发育结局。本次随访的目的是确定给早产婴儿补充DHA是否能改善与额叶功能相关的脑区,即注意力和易分心程度。
我们将评估来自“N-3(ω-3)脂肪酸改善呼吸结局(N3RO)”多中心双盲随机对照DHA补充试验的部分儿童。妊娠<29周的婴儿在开始肠内喂养的头3天内被随机分配,接受含60毫克/千克/天DHA的肠内乳剂或对照乳剂,直至月经后年龄36周。儿童将在矫正年龄18个月时接受多项注意力测试。主要结局是注意力集中在玩具上时被分散注意力的平均时间。次要结局是注意力的其他方面,以及(如有可能)使用贝利婴幼儿发展量表第三版对认知、语言和运动发育进行评估。至少将评估72名儿童,以确保有85%的把握度检测到对主要结局的影响。家庭和研究人员对分组情况不知情。所有分析将按照意向性分析原则进行。
在研究开始前,所有程序均获得相关机构伦理委员会的批准。研究结果将在同行评审的期刊出版物和学术报告中发表。
ACTRN12612000503820;预结果。