评估早产儿（<29 周）认知能力是否可以通过干预ω-3 长链多不饱和脂肪酸二十二碳六烯酸（DHA）改善的方案：一项随机对照试验的随访。
Protocol for assessing whether cognition of preterm infants <29 weeks' gestation can be improved by an intervention with the omega-3 long-chain polyunsaturated fatty acid docosahexaenoic acid (DHA): a follow-up of a randomised controlled trial.
机构信息
Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia
School of Psychology & Discipline of Paediatrics, Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.
出版信息
BMJ Open. 2021 Feb 5;11(2):e041597. doi: 10.1136/bmjopen-2020-041597.
INTRODUCTION
Docosahexaenoic acid (DHA) is an omega-3 (n-3) fatty acid that accumulates into neural tissue during the last trimester of pregnancy, as the fetal brain is undergoing a growth spurt. Infants born <29 weeks' gestation are deprived the normal in utero supply of DHA during this period of rapid brain development. Insufficient dietary DHA postnatally may contribute to the cognitive impairments common among this population. This follow-up of the N-3 fatty acids for improvement in respiratory outcomes (N3RO) randomised controlled trial aims to determine if enteral DHA supplementation in infants born <29 weeks' gestation during the first months of life improves cognitive development at 5 years of age corrected for prematurity.
METHODS AND ANALYSIS
N3RO was a randomised controlled trial of enteral DHA supplementation (60 mg/kg/day) or a control emulsion (without DHA) in 1273 infants born <29 weeks' gestation to determine the effect on bronchopulmonary dysplasia (BPD). We showed that DHA supplementation did not reduce the risk of BPD and may have increased the risk.In this follow-up at 5 years' corrected age, a predefined subset (n=655) of children from five Australian sites will be invited to attend a cognitive assessment with a psychologist. Children will be administered the Wechsler Preschool and Primary Scale of Intelligence (fourth edition) and a measure of inhibitory control (fruit stroop), while height, weight and head circumference will be measured.The primary outcome is full-scale IQ. To ensure 90% power, a minimum of 592 children are needed to detect a four-point difference in IQ between the groups.Research personnel and families remain blinded to group assignment.
ETHICS AND DISSEMINATION
The Women's and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/17/WCHN/187). Caregivers will give informed consent prior to taking part in this follow-up study. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
ACTRN12612000503820.
简介
二十二碳六烯酸（DHA）是一种 ω-3（n-3）脂肪酸，在妊娠最后三个月胎儿大脑快速发育时积聚到神经组织中。妊娠 29 周以下出生的婴儿在这段大脑快速发育期间，无法正常获得宫内供应的 DHA。出生后 DHA 摄入不足可能导致该人群常见的认知障碍。本项 N-3 脂肪酸改善呼吸结局（N3RO）随机对照试验的随访旨在确定在生命的第一个月内，给妊娠 29 周以下出生的婴儿补充经口 DHA（60mg/kg/天）是否能改善 5 岁时的认知发育，以矫正早产。
方法和分析
N3RO 是一项关于经口 DHA 补充（60mg/kg/天）或不含 DHA 的对照乳剂在 1273 名妊娠 29 周以下出生的婴儿中的随机对照试验，以确定其对支气管肺发育不良（BPD）的影响。我们发现 DHA 补充并没有降低 BPD 的风险，反而可能增加了这种风险。在这项随访研究中，将邀请来自澳大利亚五个地点的 655 名儿童参加认知评估，由心理学家进行评估。儿童将接受韦氏学前和小学智力量表（第四版）和抑制控制测试（水果斯特鲁普测试），同时测量身高、体重和头围。主要结果是全量表智商。为确保 90%的效力，需要至少 592 名儿童才能检测到两组之间智商差异为 4 分。研究人员和家庭仍对分组保持盲态。
伦理和传播
妇女和儿童健康网络人类研究伦理委员会审查并批准了该研究（HREC/17/WCHN/187）。在参与这项随访研究之前，照顾者将给予知情同意。本研究的结果将通过同行评审的出版物和会议演讲进行传播。
试验注册号
ACTRN12612000503820。
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